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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT02981472
Registration number
NCT02981472
Ethics application status
Date submitted
18/11/2016
Date registered
5/12/2016
Date last updated
3/10/2022
Titles & IDs
Public title
A Study of the Safety and Pharmacokinetics of Apixaban Versus Vitamin K Antagonist (VKA) or Low Molecular Weight Heparin (LMWH) in Pediatric Subjects With Congenital or Acquired Heart Disease Requiring Anticoagulation
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Scientific title
A Prospective, Randomized, Open Label, Multi-center Study of the Safety and Pharmacokinetics of Apixaban Versus Vitamin K Antagonist or LMWH in Pediatric Subjects With Congenital or Acquired Heart Disease Requiring Chronic Anticoagulation for Thromboembolism Prevention
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Secondary ID [1]
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2016-001247-39
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Secondary ID [2]
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CV185-362
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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:
Thrombosis
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Condition category
Condition code
Cardiovascular
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Coronary heart disease
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Cardiovascular
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Other cardiovascular diseases
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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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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Apixaban
Treatment: Drugs - Vitamin K Antagonist (VKA)
Treatment: Drugs - Low Molecular Weight Heparin (LMWH)
Experimental: Apixaban -
Active comparator: LMWH/VKA -
Treatment: Drugs: Apixaban
Specified dose on specified days
Treatment: Drugs: Vitamin K Antagonist (VKA)
Specified dose on specified days
Treatment: Drugs: Low Molecular Weight Heparin (LMWH)
Specified dose on specified days
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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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Composite of Adjudicated Major or Clinically Relevant Non-Major (CRNM) Bleeding Events
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Assessment method [1]
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The number of participants with adjudicated major or CRNM bleeding events per the Perinatal and Paediatric Haemostasis Subcommittee of International Society on Thrombosis and Haemostasis (ISTH) criteria. Events are adjudicated by a blinded, independent events adjudication committee (EAC).
Major bleeding satisfies one or more of the following criteria: fatal bleeding, clinically overt bleeding associated with a decrease in hemoglobin of at least 20 g/L (i.e., 2 g/dL) in a 24-hour period, bleeding that is retroperitoneal, pulmonary, intracranial, or otherwise involves the CNS, or bleeding that requires surgical intervention in an operating suite, including interventional radiology.
CRNM bleeding satisfies one or both of the following criteria: overt bleeding for which blood product is administered and not directly attributable to the subject's underlying medical condition or bleeding that requires medical or surgical intervention to restore hemostasis, other than in an operating room.
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Timepoint [1]
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From first dose to 2 days after last dose (Up to approximately 12 months)
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Secondary outcome [1]
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The Number of Participants With Thrombotic Events and Thromboembolic Event-Related Death
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Assessment method [1]
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The number of participants with thromboembolic events (intra-cardiac, shunt, inside Fontan pathway, pulmonary embolism (PE), stroke, other arterial or venous thromboembolic events, etc.) and thromboembolic event-related death detected by imaging or clinical diagnosis.
Death and thromboembolic events are adjudicated by a blinded, independent events adjudication committee (EAC)
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Timepoint [1]
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From randomization to 2 days after last dose (Up to approximately 12 months)
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Secondary outcome [2]
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The Number of Participants With Adjudicated Major Bleeding
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Assessment method [2]
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The number of participants with adjudicated major bleeding events per the Perinatal and Paediatric Haemostasis Subcommittee of International Society on Thrombosis and Haemostasis (ISTH) criteria. Major bleeding events are adjudicated by a blinded, independent events adjudication committee (EAC).
Major bleeding is defined as bleeding that satisfies one or more of the following criteria:
* fatal bleeding
* clinically overt bleeding associated with a decrease in hemoglobin of at least 20 g/L (i.e., 2 g/dL) in a 24-hour period
* bleeding that is retroperitoneal, pulmonary, intracranial, or otherwise involves the CNS
* bleeding that requires surgical intervention in an operating suite, including interventional radiology
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Timepoint [2]
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From first dose to 2 days after last dose (Up to approximately 12 months)
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Secondary outcome [3]
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The Number of Participants With Adjudicated CRNM Bleeding
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Assessment method [3]
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The number of participants with adjudicated clinically relevant non-major (CRNM) bleeding events per the Perinatal and Paediatric Haemostasis Subcommittee of International Society on Thrombosis and Haemostasis (ISTH) criteria. CRNM bleeding events are adjudicated by a blinded, independent events adjudication committee (EAC).
CRNM bleeding is defined as bleeding that satisfies one or both of the following criteria:
* overt bleeding for which blood product is administered and not directly attributable to the subject's underlying medical condition
* bleeding that requires medical or surgical intervention to restore hemostasis, other than in an operating room
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Timepoint [3]
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From first dose to 2 days after last dose (Up to approximately 12 months)
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Secondary outcome [4]
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The Number of Participants With All Adjudicated Bleeding
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Assessment method [4]
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The number of participants with all adjudicated bleeding events
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Timepoint [4]
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From first dose to 2 days after last dose (Up to approximately 12 months)
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Secondary outcome [5]
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The Number of Participants With Drug Discontinuation Due to Adverse Effects, Intolerability, or Bleeding
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Assessment method [5]
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The number of participants with drug discontinuation due to adverse effects, intolerability, or bleeding.
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Timepoint [5]
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From first dose to 2 days after last dose (Up to approximately 12 months)
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Secondary outcome [6]
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The Number of Participant Deaths in the Study
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Assessment method [6]
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The number of participant deaths in the study.
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Timepoint [6]
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From first dose to 2 days after last dose (Up to approximately 12 months)
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Secondary outcome [7]
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Maximum Observed Concentration (Cmax)
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Assessment method [7]
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Timepoint [7]
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From first dose up to 6 months after first dose
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Secondary outcome [8]
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Trough Observed Concentration (Cmin)
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Assessment method [8]
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Timepoint [8]
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From first dose up to 6 months after first dose
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Secondary outcome [9]
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Area Under the Concentration-Time Curve in One Dosing Interval (AUC (TAU))
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Assessment method [9]
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Timepoint [9]
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From first dose up to 6 months after first dose
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Secondary outcome [10]
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Time of Maximum Observed Concentration (Tmax)
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Assessment method [10]
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Timepoint [10]
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From first dose up to 6 months after first dose
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Secondary outcome [11]
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Anti-FXa Activity
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Assessment method [11]
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Anti-FXa Activity was measured to assess participant plasma apixaban levels.
125 participants received at least one dose of apixaban and had anti-FXa samples collected that contributed measurements to at least one of the timepoints below.
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Timepoint [11]
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From first dose up to 6 months after first dose
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Secondary outcome [12]
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Chromogenic FX Assay (Apparent FX Level)
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Assessment method [12]
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Chromogenic FX was measured to assess (apparent) FX levels in participants and inhibition of FXa by apixaban.
125 participants received at least one dose of apixaban and had chromogenic FX assay samples collected that contributed measurements to at least one of the timepoints below.
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Timepoint [12]
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From first dose up to 6 months after first dose
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Secondary outcome [13]
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The Child and Parent Reports of Pediatric Quality of Life Inventory (PedsQL)
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Assessment method [13]
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Subjects' quality of life was measured using the PedsQL instrument administered only to English-speaking children/parents. Only subjects who completed the questionnaires at both baseline and post-baseline visits were included in the analyses.
PedsQL consists of 23 items scored on a 5-point Likert scale from 0 (never) to 4 (almost always) or for the child report for younger children ages 5-7, a 3-point Likert scale: 0 (Not at all), 2 (Sometimes), and 4 (A lot).
Scores are reverse scored and transformed to a 0-100 scale as follows: 0=100, 1=75, 3=25, 4=0. Higher scores indicate a better HRQOL and/or lower problems.
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Timepoint [13]
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from randomization up to 12 months after randomization
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Secondary outcome [14]
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Kids Informed Decrease Complications Learning on Thrombosis (KIDCLOT) IMPACT Score
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Assessment method [14]
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Subjects' quality of life was measured using the KIDCLOT instrument administered only to English-speaking children/parents. Only subjects who completed the questionnaires at both baseline and post-baseline visits were included in the analyses.
KIDCLOT Parent inventory uses a 5 point Likert scale from 1 (N/A), 2 (Never), 3 (Rarely), 4 ( Now and then), 5 (Often). Child inventory uses a 4 point Likert scale 1 (N/A), 2 (Never), 3 (Now and then), 5 (Always). Values are scores as follows 1=0, 2=1, 3=2, 4=3, 5=4. Score interpretation is 0 to 100 percent IMPACT of anticoagulation on a child's life therefore, higher scores indicates a more negative effect.
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Timepoint [14]
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from randomization up to 12 months after randomization
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Eligibility
Key inclusion criteria
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
* Males and Females, 28 days to < 18 years of age, inclusive
* Congenital or acquired heart diseases requiring chronic anticoagulation for thromboprophylaxis (eg, single ventricle physiology including all 3 stages of palliation, dilated cardiomyopathy, Kawasaki disease with coronary aneurysms, and pulmonary hypertension)
* Eligible participants include those who newly start anticoagulants and those who are currently on VKA or LMWH or other anticoagulants for thromboprophylaxis
* Able to tolerate enteral medication [eg, by mouth, nasogastric tube, or gastric tube]
* Participants 28 days to < 3 months must be able to tolerate oral/nasogastric tube (NGT)/gastric tube (GT) feeds for at least 5 days prior to randomization
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Minimum age
28
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Maximum age
17
Years
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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
* Recent thromboembolic events less than 6 months prior to enrollment
* Weight < 3 kg
* Use of aggressive life-saving therapies such as ventricular assist devices (VAD) or extracorporeal membrane oxygenation (ECMO) at the time of enrollment
* Artificial heart valves and mechanical heart valves
* Known inherited bleeding disorder or coagulopathy (e.g. hemophilia, von Willebrand disease, etc.)
* Active bleeding at the time of enrollment
* Any major bleeding other than perioperative in the preceding 3 months
* Known intracranial congenital vascular malformation or tumor
* Confirmed diagnosis of a GI ulcer
* Known antiphospholipid syndrome (APS).
Other protocol defined inclusion/exclusion criteria apply
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Study design
Purpose of the study
Treatment
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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
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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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
19/01/2017
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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
18/10/2021
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Sample size
Target
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Accrual to date
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Final
192
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Local Institution - 0030 - Parkville
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Recruitment postcode(s) [1]
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3052 - Parkville
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Arizona
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Country [2]
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United States of America
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State/province [2]
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California
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Country [3]
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United States of America
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State/province [3]
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Colorado
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Country [4]
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United States of America
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State/province [4]
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Georgia
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Country [5]
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0
United States of America
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State/province [5]
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Indiana
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Country [6]
0
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United States of America
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State/province [6]
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Massachusetts
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Country [7]
0
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United States of America
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State/province [7]
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Michigan
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Country [8]
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United States of America
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State/province [8]
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Missouri
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Country [9]
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United States of America
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Ohio
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Country [10]
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United States of America
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State/province [10]
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Pennsylvania
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Country [11]
0
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United States of America
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State/province [11]
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South Carolina
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Country [12]
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United States of America
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State/province [12]
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Texas
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Country [13]
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United States of America
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State/province [13]
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Utah
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Country [14]
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United States of America
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Washington
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Argentina
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Buenos Aires
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Country [16]
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Austria
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Vienna
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Country [17]
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Brazil
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Parana
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Country [18]
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Brazil
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State/province [18]
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Rio Grande Do Sul
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Brazil
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Sao Paulo
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Canada
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Ontario
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Finland
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HUS
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Germany
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Freiburg
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Germany
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Hamburg
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Germany
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Muenchen
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Israel
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Petach Tikva
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Israel
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Tel Hashomer
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Italy
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Roma
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Italy
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Bologna
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Italy
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Milano
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Mexico
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Distrito Federal
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Mexico
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Guanajuato
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Russian Federation
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Ekaterinburg
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Russian Federation
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Kazan
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Russian Federation
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Kemerovo
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Russian Federation
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Novosibirsk
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Spain
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Barcelona
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Spain
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Madrid
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United Kingdom
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Leicestershire
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Country [39]
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United Kingdom
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State/province [39]
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Somerset
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Country [40]
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United Kingdom
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State/province [40]
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Manchester
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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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Country
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Other collaborator category [1]
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Other
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Name [1]
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Pediatric Heart Network
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Address [1]
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Other collaborator category [2]
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Commercial sector/industry
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Name [2]
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Pfizer
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Address [2]
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Ethics approval
Ethics application status
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Summary
Brief summary
To investigate the safety and pharmacokinetics of apixaban in children with congenital or acquired heart disease who have a need for anticoagulation.
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Trial website
https://clinicaltrials.gov/study/NCT02981472
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Bristol-Myers Squibb
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Address
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Bristol-Myers Squibb
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Phone
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Fax
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Email
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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
Type
Other Details
Attachment
Study protocol
Study Protocol and Statistical Analysis Plan
https://cdn.clinicaltrials.gov/large-docs/72/NCT02981472/Prot_SAP_000.pdf
Statistical analysis plan
Study Protocol and Statistical Analysis Plan
https://cdn.clinicaltrials.gov/large-docs/72/NCT02981472/Prot_SAP_000.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT02981472
Download to PDF