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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00371683
Registration number
NCT00371683
Ethics application status
Date submitted
30/08/2006
Date registered
4/09/2006
Date last updated
30/12/2015
Titles & IDs
Public title
Study of Apixaban for the Prevention of Thrombosis-related Events Following Knee Replacement Surgery
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Scientific title
A Phase 3 Randomized, Double-Blind Active-Controlled (Enoxaparin), Parallel-Group, Multi-Center Study to Evaluate the Safety and Efficacy of Oral Apixaban in Subjects Undergoing Elective Total Knee Replacement Surgery
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Secondary ID [1]
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CV185-034
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Deep Vein Thrombosis
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Pulmonary Embolism
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Condition category
Condition code
Cardiovascular
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Diseases of the vasculature and circulation including the lymphatic system
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Blood
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Clotting disorders
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Respiratory
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Other respiratory disorders / diseases
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Cardiovascular
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Other cardiovascular diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Enoxaparin + Placebo
Treatment: Drugs - Apixaban + Placebo
Active comparator: A1 - + placebo
Experimental: A2 - + placebo
Treatment: Drugs: Enoxaparin + Placebo
Syringes + tablets, Subcutaneous + Oral, 30mg, twice daily, 12 day treatment period
Treatment: Drugs: Apixaban + Placebo
Tablet + Syringes, Oral + subcutaneous, 2.5 mg, twice daily, 12 day treatment period
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Event Rate of the Composite of Adjudicated Venous Thromboembolism (VTE) Events and All-Cause Death With Onset During the Intended Treatment Period - Primary Subjects
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Assessment method [1]
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An Independent Central Adjudication Committee (ICAC) adjudicated all venograms, suspected symptomatic deep vein thrombosis (DVT) and pulmonary embolism (PE), acute clinically overt bleeding events, suspected thrombocytopenia, suspected acute MI, suspected acute stroke, and cause of death. Event rate was number of participants with the composite endpoint divided by the number of participants analyzed and reported as percentage (%). Surgery=Day 1; Randomization/Treatment started on Day of Surgery or the next day (Day 1 or Day 2). A mandatory bilateral ascending contrast venogram was performed on all participants after 12 days (±2 days) of study treatment. Intended Treatment Period=starts on the day of randomization; for treated participants, the period ends at the latter of 2 days after last dose of study drug or 14 days after the first dose of study drug; for randomized participants who were not treated, the period ends 14 days after randomization.
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Timepoint [1]
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From Day 1 or Day 2 to last dose, plus 2 days or 14 days post randomization
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Primary outcome [2]
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Event Rate for Participants With Major Bleeding, Clinically Relevant Non-Major Bleeding, Major or Clinically Relevant Non-Major Bleeding, Any Bleeding With Onset During the Treatment Period - Treated Population
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Assessment method [2]
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ICAC adjudicated acute clinically overt bleeding events as per International Society on Thrombosis and Hemostasis (ISTH) guidelines modified for surgical patients. Event rate was number of participants with the composite endpoint divided by the number of participants analyzed (%). Clinically relevant (CR); Non-Major (N-M) Bleeding. Day 1=Day of surgery. Treatment started (first dose) day of surgery or next day. Treatment continued for 12 days.
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Timepoint [2]
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First dose of study drug to last dose, plus 2 days post last dose
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Primary outcome [3]
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Event Rate for Participants With Major Bleeding, Clinically Relevant (CR) Non-Major (N-M) Bleeding , Major or Clinically Relevant (CR) Non-Major (N-M) Bleeding, Any Bleeding With Onset During the Follow-Up Period
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Assessment method [3]
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ICAC adjudicated acute clinically overt bleeding events as per International Society on Thrombosis and Hemostasis (ISTH) guidelines modified for surgical patients. Event rate was number of participants with the composite endpoint divided by the number of participants analyzed (%). Follow up Period was from the end of the treatment period (last dose) up to 60 days post last dose, Day 72.
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Timepoint [3]
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Last dose of study drug to Day 72 (60 days)
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Secondary outcome [1]
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Event Rate of Composite of Adjudicated Proximal DVT, Non-Fatal PE and All-Cause Death With Onset During the Intended Treatment Period PE and All-cause Death During the Intended Treatment Period
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Assessment method [1]
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A mandatory bilateral ascending contrast venogram was performed on all participants after 12 days (±2 days) of study treatment. An ICAC adjudicated all venograms, suspected proximal DVT and non-fatal PE, and all-cause of death. Event rate was number of participants with the composite endpoint divided by the number of participants analyzed and reported as percentage (%).
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Timepoint [1]
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From Day 1 or Day 2 to last dose, plus 2 days or 14 days post randomization
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Secondary outcome [2]
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Event Rate of Adjudicated VTE / VTE-related Death With Onset During the Treatment Period
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Assessment method [2]
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VTE / VTE-related death was defined as the combination of fatal or non-fatal PE, and symptomatic or asymptomatic DVT. A mandatory bilateral ascending contrast venogram was performed on all participants after 12 days (±2 days) of study treatment. An ICAC adjudicated all venograms, suspected symptomatic DVT and PE, and cause of death. Event rate was number of participants with the endpoint divided by the number of participant's analyzed (%).
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Timepoint [2]
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From Day 1 or Day 2 to last dose, plus 2 days or 14 days post randomization
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Secondary outcome [3]
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Event Rate for Participants With Proximal DVT/Non-Fatal PE/ VTE-Related Death With Onset During the Intended Treatment Period
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Assessment method [3]
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An ICAC adjudicated all venograms, suspected symptomatic DVT and PE, and cause of death. Event rate was number of participants with the endpoint divided by the number of participant's analyzed (%).
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Timepoint [3]
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From Day 1 or Day 2 to last dose, plus 2 days or 14 days post randomization
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Secondary outcome [4]
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Event Rate for Total Participants With Adjudicated VTE/All-Cause Death With Onset During the Intended Treatment Period
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Assessment method [4]
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ICAC adjudicated all venograms, suspected symptomatic DVT and PE, and cause of death. Event rate was number of participants with the endpoint divided by the number of participant's analyzed (%).
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Timepoint [4]
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From Day 1 or Day 2 to last dose, plus 2 days or 14 days post randomization
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Secondary outcome [5]
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Event Rate for Total Participants With VTE/ VTE-Related Death With Onset During the Intended Treatment Period
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Assessment method [5]
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ICAC adjudicated all venograms, suspected symptomatic DVT and PE, and cause of death. VTE includes DVT and PE. Event rate was number of participants with the endpoint divided by the number of participant's analyzed (%).
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Timepoint [5]
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From Day 1 or Day 2 to last dose, plus 2 days or 14 days post randomization
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Secondary outcome [6]
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Event Rate for Participants With All-Cause Death During the Intended Treatment Period
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Assessment method [6]
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Event rate was number of participants with all-cause death divided by the number of participant's analyzed (%).
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Timepoint [6]
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From Day 1 or Day 2 to last dose, plus 2 days or 14 days post randomization
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Secondary outcome [7]
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Event Rate for Participants With VTE-Related Death With Onset During the Intended Treatment Period
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Assessment method [7]
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ICAC adjudicated cause of death. Event rate was number of participants with the endpoint divided by the number of participant's analyzed (%).
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Timepoint [7]
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From Day 1 or Day 2 to last dose, plus 2 days or 14 days post randomization
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Secondary outcome [8]
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Event Rate for Participants With Symptomatic VTE/ All-Cause Death With Onset During the Intended Treatment Period
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Assessment method [8]
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ICAC adjudicated suspected symptomatic DVT and PE, and cause of death. Event rate was number of participants with the endpoint divided by the number of participant's analyzed (%).
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Timepoint [8]
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From Day 1 or Day 2 to last dose, plus 2 days or 14 days post randomization
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Secondary outcome [9]
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Event Rate for Participants With Symptomatic VTE/ VTE-Related Death With Onset During the Intended Treatment Period
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Assessment method [9]
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ICAC adjudicated suspected symptomatic DVT and PE, and cause of death. Event rate was number of participants with the endpoint divided by the number of participant's analyzed (%).
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Timepoint [9]
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From Day 1 or Day 2 to last dose, plus 2 days or 14 days post randomization
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Secondary outcome [10]
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Event Rate for Participants With VTE/Major Bleeding/All-Cause Death With Onset During the Intended Treatment Period
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Assessment method [10]
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ICAC adjudicated VTE, acute clinically overt bleeding events, suspected thrombocytopenia, and cause of death. Event rate was number of participants with the composite endpoint divided by the number of participants analyzed (%).
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Timepoint [10]
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From Day 1 or Day 2 to last dose, plus 2 days or 14 days post randomization
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Secondary outcome [11]
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Event Rate for Participants With PE (Fatal or Non-Fatal), DVT (All, Symptomatic Proximal, and Distal, Asymptomatic) With Onset During the Intended Treatment Period
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Assessment method [11]
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An ICAC adjudicated all venograms, suspected symptomatic deep vein thrombosis (DVT) and pulmonary embolism (PE), acute clinically overt bleeding events, suspected thrombocytopenia, suspected acute MI, suspected acute stroke, and cause of death. Event rate was number of participants with the composite endpoint divided by the number of participants analyzed (%).
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Timepoint [11]
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From Day 1 or Day 2 to last dose, plus 2 days or 14 days post randomization
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Secondary outcome [12]
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Event Rate for Participants With Proximal DVT, Distal DVT, Asymptomatic Proximal DVT, Asymptomatic Distal DVT With Onset During the Intended Treatment Period
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Assessment method [12]
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ICAC adjudicated all venograms and suspected symptomatic DVT. Event rate was number of participants with the endpoint divided by the number of participant's analyzed (%).
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Timepoint [12]
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From Day 1 or Day 2 to last dose, plus 2 days or 14 days post randomization
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Secondary outcome [13]
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Event Rate for Participants With Adjudicated Myocardial Infarction (MI) Acute Ischemic Stroke and Thromboembolic Events With Onset During the Treatment Period
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Assessment method [13]
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ICAC adjudicated acute clinically overt bleeding events, suspected thrombocytopenia, suspected acute MI, suspected acute stroke per International Society on Thrombosis and Hemostasis (ISTH) guidelines modified for surgical patients. Event rate was number of participants with the composite endpoint divided by the number of participants analyzed (%).
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Timepoint [13]
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From first dose to last dose, plus 2 days (12 days, plus 2)
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Secondary outcome [14]
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Event Rate of Adjudicated MI, Stroke, and Thrombocytopenia Events During the Follow-Up Period
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Assessment method [14]
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A 60-day follow-up period started after the last dose of study drug and continued until the End of Study Visit on Day 72 (60 days ± 3 days, after the last dose of study drug). Event rate was number of participants with the endpoint divided by the number of participants analyzed (%). ICAC adjudicated acute clinically overt bleeding events, suspected thrombocytopenia, suspected acute MI, suspected acute stroke per ISTH guidelines modified for surgical patients.
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Timepoint [14]
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Post last dose of study drug to Day 72 (60 days)
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Secondary outcome [15]
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Number of Participants With Serious Adverse Events (SAEs), Bleeding Adverse Events (AEs), AEs Leading to Discontinuation, and Deaths - Treated Population
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Assessment method [15]
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AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization.
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Timepoint [15]
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First dose to last dose, plus 2 days for AEs (12 + 2 days) or plus 30 days for SAEs (12 + 30 days)
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Secondary outcome [16]
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Mean Change From Baseline in Systolic and Diastolic Blood Pressure During the Treatment Period
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Assessment method [16]
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Treatment Period=the period from first dose of study drug through 2 days after discontinuation of study drug (12 + 2 days). Baseline=measurement prior to first dose of study drug. Blood pressures (BP) were measured during screening (pre-operative, post-operative) and in the treatment period on Days 1 (day of first dose), 2, 3, 4,12 (end of treatment). Systolic and diastolic pressures were measured in millimeters of mercury (mmHg).
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Timepoint [16]
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Baseline to last dose of study drug, plus 2 days
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Secondary outcome [17]
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Mean Change From Baseline in Heart Rate During the Treatment Period
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Assessment method [17]
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Treatment Period=the period from first dose of study drug through 2 days after discontinuation of study drug (12 + 2 days). Baseline=measurement prior to first dose of study drug. Heart rate was measured during screening (pre-operative, post-operative) and in the treatment period on Days 1 (day of first dose), 2, 3, 4,12 (end of treatment). Heart rate was measured in beats per minute (bpm).
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Timepoint [17]
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Baseline to last dose of study drug, plus 2 days
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Secondary outcome [18]
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Number of Participants With Hematology Laboratory Marked Abnormality During the Treatment Period
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Assessment method [18]
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Treatment Period=the period from first dose of study drug through 2 days after discontinuation of study drug. Hematology profile was measured during screening (pre-operative, post-operative) and in the Treatment Period on Days 2, 3, 4, 12 (end of treatment). Upper limit of normal (ULN); lower limit of normal (LLN). Platelet Count low: \< 100,000/mm\^3 (or \< 100\*109 cells/L). Erythrocytes low: \< 0.75 \*pre-dose. Hemoglobin low: \> 2 g/dL decrease compared to pre-dose or Value = 8 g/dL. Hematocrit low: \< 0.75\*pre-dose . Leukocytes: \< 0.75\*LLN or \> 1.25\* ULN, or if pre-dose \< LLN then use \< 0.8\*predose or \> ULN if pre-dose \> ULN then use \> 1.2\*predose or \< LLN. Lymphocytes (absolute): \< 0.750\*10\^3 cells/µL or \> 7.50\*10\^3 cells/ µL. Eosinophils (absolute) high: \> 0.750\*10\^3 cells/µL. Basophils(absolute) high: \> 400/mm\^3 (or \> 0.4\*103 cells/µL). Monocytes (absolute) high: \> 2000/mm\^3 (or \> 2\*103 cells/µL). Neutrophils(absolute) high: \< 1.0\*103 cells/µL.
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Timepoint [18]
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First dose to last dose of study drug (12 days), plus 2 days
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Secondary outcome [19]
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Number of Participants With Liver and Kidney Function Chemistry Laboratory Marked Abnormalities During the Treatment Period
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Assessment method [19]
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Treatment Period=the period from first dose of study drug through 2 days after discontinuation of study drug. Laboratory Chemistry profile was measured during screening (pre-operative, post-operative) and in the Treatment Period on Days 4, and 12 (end of treatment). Bilirubin (direct) high: \> 1.5\*ULN. Total bilirubin: : \> 2\*ULN, Alanine Aminotransferase (ALT) high: \> 3\*ULN. Alkaline Phosphatase (ALP): \> 2\*ULN. Aspartate Aminotransferase (AST): \> 3\*ULN. Creatinine: \> 1.5\*ULN.
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Timepoint [19]
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First dose to last dose of study drug (12 days), plus 2 days
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Secondary outcome [20]
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Number of Participants With Electrolyte Chemistry Laboratory Marked Abnormalities During the Treatment Period
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Assessment method [20]
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Laboratory Chemistry profile was measured during screening (pre-operative, post-operative) and in the Treatment Period on Days 4, and 12 (end of treatment). Potassium: \< 0.9\*LLN or \> 1.1\*ULN, or if pre-dose \< LLN then use \< 0.9\*predose or \> ULN if pre-dose \> ULN then use \> 1.1\*predose or \< LLN. Calcium: \< 0.8\*LLN or \> 1.2\*ULN, or if pre-dose \< LLN then use \< 0.75\*predose or \> ULN If pre-dose \> ULN then use \> 1.25\*predose or \< LLN. Chloride: \< 0.9\*LLN or \> 1.1\*ULN, or if pre-dose \< LLN then use \< 0.9\*predose or \> ULN if pre-dose \> ULN then use \> 1.1\*predose or \< LLN. Sodium: \< 0.95\*LLN or \> 1.05\*ULN, or if pre-dose \< LLN then use \< 0.95\*predose or \>ULN if pre-dose \> ULN then use \> 1.05\*predose or \< LLN. Bicarbonate: \< 0.75\*LLN or \> 1.25\*ULN, or if pre-dose \< LLN then use \< 0.75\*predose or \> ULN if pre-dose \> ULN then use \> 1.25\*predose or \< LLN.
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Timepoint [20]
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First dose to last dose of study drug (12 days), plus 2 days
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Secondary outcome [21]
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Number of Participants With Other Chemistry Laboratory Marked Abnormalities During the Treatment Period
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Assessment method [21]
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Treatment Period=the period from first dose of study drug through 2 days after discontinuation of study drug. Laboratory Chemistry profile was measured during screening (pre-operative, post-operative) and in the Treatment Period on Days 4, and 12 (end of treatment). Fasting Glucose: if pre-dose \< LLN then use \< 0.8\*predose; or \> ULN if pre-dose \> ULN then use \> 2.0\*predose or \<LLN. Total Protein: \< 0.9\*LLN or \> 1.1\*ULN, or if pre-dose \< LLN then use 0.9\*predose or \> ULN if pre-dose \> ULN then use 1.1\*predose or \< LLN. Uric Acid: \> 1.5\*ULN, or if pre-dose \> ULN then use \> 2\*predose. Creatine Kinase (CK): \> 5\*ULN.
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Timepoint [21]
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First dose to last dose of study drug (12 days), plus 2 days
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Eligibility
Key inclusion criteria
Key
* Men and non-pregnant, non-breastfeeding women
* 18 years or older
* Scheduled for knee replacement surgery
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* hereditary or acquired bleeding disorders
* clotting disorders
* bleeding or high risk for bleeding
* drugs that affect bleeding or coagulation
* need for ongoing parenteral or oral anticoagulation
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/11/2006
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/05/2008
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Sample size
Target
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Accrual to date
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Final
3608
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Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,VIC,WA
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Recruitment hospital [1]
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Local Institution - Garran
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Recruitment hospital [2]
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0
Local Institution - Camperdown
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Recruitment hospital [3]
0
0
Local Institution - Caringbah
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Recruitment hospital [4]
0
0
Local Institution - Lismore
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Recruitment hospital [5]
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0
Local Institution - Gold Coast
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Recruitment hospital [6]
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Local Institution - Adelaide
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Recruitment hospital [7]
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Local Institution - Bedford Park
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Recruitment hospital [8]
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Local Institution - Box Hill
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Recruitment hospital [9]
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Local Institution - Windsor
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Recruitment hospital [10]
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Local Institution - Perth
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Recruitment postcode(s) [1]
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2605 - Garran
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Recruitment postcode(s) [2]
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NSW 2050 - Camperdown
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Recruitment postcode(s) [3]
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2229 - Caringbah
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Recruitment postcode(s) [4]
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0
2480 - Lismore
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Recruitment postcode(s) [5]
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0
4215 - Gold Coast
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Recruitment postcode(s) [6]
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0
5011 - Adelaide
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Recruitment postcode(s) [7]
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0
5042 - Bedford Park
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Recruitment postcode(s) [8]
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0
3128 - Box Hill
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Recruitment postcode(s) [9]
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0
3181 - Windsor
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Recruitment postcode(s) [10]
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0
6001 - Perth
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Recruitment outside Australia
Country [1]
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0
United States of America
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State/province [1]
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0
Alabama
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Country [2]
0
0
United States of America
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State/province [2]
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0
Arkansas
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Country [3]
0
0
United States of America
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State/province [3]
0
0
Colorado
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Country [4]
0
0
United States of America
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State/province [4]
0
0
Connecticut
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Country [5]
0
0
United States of America
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State/province [5]
0
0
District of Columbia
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Country [6]
0
0
United States of America
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State/province [6]
0
0
Florida
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Country [7]
0
0
United States of America
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State/province [7]
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0
Georgia
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Country [8]
0
0
United States of America
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State/province [8]
0
0
Idaho
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Country [9]
0
0
United States of America
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State/province [9]
0
0
Kentucky
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Country [10]
0
0
United States of America
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State/province [10]
0
0
South Carolina
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Country [11]
0
0
United States of America
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State/province [11]
0
0
Texas
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Country [12]
0
0
Argentina
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State/province [12]
0
0
Buenos Aires
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Country [13]
0
0
Argentina
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State/province [13]
0
0
Cordoba
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Country [14]
0
0
Brazil
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State/province [14]
0
0
Parana
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Country [15]
0
0
Brazil
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State/province [15]
0
0
Rio Grande Do Sul
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Country [16]
0
0
Brazil
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State/province [16]
0
0
Sao Paulo
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Country [17]
0
0
Canada
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State/province [17]
0
0
Alberta
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Country [18]
0
0
Canada
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State/province [18]
0
0
Ontario
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Country [19]
0
0
Canada
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State/province [19]
0
0
Prince Edward Island
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Country [20]
0
0
Canada
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State/province [20]
0
0
Quebec
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Country [21]
0
0
Denmark
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State/province [21]
0
0
Horsholm
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Country [22]
0
0
Denmark
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State/province [22]
0
0
Kopenhamn S
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Country [23]
0
0
Hungary
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State/province [23]
0
0
Kecskemet
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Country [24]
0
0
Hungary
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State/province [24]
0
0
Szekesfehervar
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Country [25]
0
0
Hungary
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State/province [25]
0
0
Szolnok
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Country [26]
0
0
Israel
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State/province [26]
0
0
Afula
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Country [27]
0
0
Israel
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State/province [27]
0
0
Beer-Sheva
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Country [28]
0
0
Israel
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State/province [28]
0
0
Haifa
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Country [29]
0
0
Israel
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State/province [29]
0
0
Holon
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Country [30]
0
0
Israel
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State/province [30]
0
0
Kfar-Saba
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Country [31]
0
0
Israel
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State/province [31]
0
0
Petach-Tikva
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Country [32]
0
0
Israel
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State/province [32]
0
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Rehovot
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Israel
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Zerifin
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Mexico
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Baja California
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Mexico
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Distrito Federal
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Mexico
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Jalisco
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Mexico
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Nuevo Leon
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Tamaulipas
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Veracruz
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Yucatan
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Chihuahua
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Poland
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Bialystok
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Poland
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Krakow
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Poland
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Lodz
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Poland
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Lublin
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Poland
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Szczecin
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Poland
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Warszawa
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Russian Federation
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Moscow
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Russian Federation
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Samara
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Russian Federation
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St. Petersburg
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Sweden
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Goteborg
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Turkey
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Adana
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Turkey
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Bursa
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Turkey
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Mersin
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Turkey
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Trabzon
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Bristol-Myers Squibb
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Address
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Ethics approval
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Summary
Brief summary
The purpose of this study is to learn if apixaban can prevent blood clots in the leg (deep vein Thrombosis \[DVT\]) and lung (pulmonary embolism \[PE\]) that sometimes occur after knee replacement surgery and to learn how apixaban compares to enoxaparin (Lovenox®) for preventing these clots. The safety of apixaban will also be studied.
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Trial website
https://clinicaltrials.gov/study/NCT00371683
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Trial related presentations / publications
Jamieson MJ, Byon W, Dettloff RW, Crawford M, Gargalovic PS, Merali SJ, Onorato J, Quintero AJ, Russ C. Apixaban Use in Obese Patients: A Review of the Pharmacokinetic, Interventional, and Observational Study Data. Am J Cardiovasc Drugs. 2022 Nov;22(6):615-631. doi: 10.1007/s40256-022-00524-x. Epub 2022 May 16. Lassen MR, Raskob GE, Gallus A, Pineo G, Chen D, Portman RJ. Apixaban or enoxaparin for thromboprophylaxis after knee replacement. N Engl J Med. 2009 Aug 6;361(6):594-604. doi: 10.1056/NEJMoa0810773. Erratum In: N Engl J Med. 2009 Oct 29;361(18):1814.
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Public notes
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Contacts
Principal investigator
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Bristol-Myers Squibb
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Bristol-Myers Squibb
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT00371683
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