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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT01583218
Registration number
NCT01583218
Ethics application status
Date submitted
16/04/2012
Date registered
23/04/2012
Date last updated
7/08/2023
Titles & IDs
Public title
Acute Medically Ill VTE Prevention With Extended Duration Betrixaban Study (The APEX Study)
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Scientific title
(Apex) Multicenter, Randomized, Active-Controlled Efficacy And Safety Study Comparing Extended Duration Betrixaban With Standard Of Care Enoxaparin For The Prevention Of Venous Thromboembolism In Acute Medically Ill Patients
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Secondary ID [1]
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0
11-019
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Universal Trial Number (UTN)
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Trial acronym
APEX
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Venous Thromboembolism (VTE)
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0
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Condition category
Condition code
Cardiovascular
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0
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Diseases of the vasculature and circulation including the lymphatic system
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Blood
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0
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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 - Betrixaban
Treatment: Drugs - Enoxaparin
Experimental: Betrixaban - Daily oral (PO) betrixaban capsules for 35 to 42 days and subcutaneous (SQ) injections of enoxaparin placebo for 10 ± 4 days
Active comparator: Enoxaparin - Daily subcutaneous (SQ) injections of enoxaparin for 10 ± 4 days and oral (PO) betrixaban placebo capsules for 35 to 42 days
Treatment: Drugs: Betrixaban
Betrixaban 80 mg PO once daily (QD) for 35 day + 7 days.
Enoxaparin Placebo: Once daily, 6-14 days
Treatment: Drugs: Enoxaparin
Enoxaparin 40 mg subcutaneous (SC) QD for 10 ± 4 days.
Betrixaban Placebo: once daily, 35 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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Modified Intent-to-Treat (mITT) Cohort 1: Percentage of Participants Experiencing the Composite Event of Symptomatic Deep Vein Thrombosis (DVT), Non-fatal Pulmonary Emboli (PE), VTE-related Death, or Asymptomatic Proximal DVT, Through Visit 3
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Assessment method [1]
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mITT Cohort 1: Percentage of participants experiencing either symptomatic DVT, non-fatal PE, venous thromboembolism (VTE) related death adjudicated by a blinded independent Clinical Events Committee (CEC) between randomization and on or before Visit 3 or Day 42 if patient did not have a Visit 3, or a blinded ultrasound core laboratory measuring of asymptomatic proximal DVT between randomization and Day 47. Visit 3 is between day 35-42 after randomization (day 1).
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Timepoint [1]
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mITT Cohort 1: Between randomization and Day 47 (max)
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Primary outcome [2]
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mITT Cohort 2: Percentage of Participants Experiencing the Composite Event of Symptomatic DVT, Non-fatal PE, VTE-related Death, or Asymptomatic Proximal DVT, Through Visit 3
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Assessment method [2]
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mITT Cohort 2: Percentage of participants experiencing either symptomatic DVT, non-fatal PE, VTE related death adjudicated by a blinded independent CEC between randomization and on or before Visit 3 or Day 42 if patient did not have a Visit 3, or a blinded ultrasound core laboratory measuring of asymptomatic proximal DVT between randomization and Day 47. Visit 3 is between day 35-42 after randomization (day 1).
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Timepoint [2]
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mITT Cohort 2: Between randomization and Day 47 (max)
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Primary outcome [3]
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mITT: Percentage of Participants Experiencing the Composite Event of Symptomatic DVT, Non-fatal PE, VTE-related Death, or Asymptomatic Proximal DVT, Through Visit 3
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Assessment method [3]
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mITT: Percentage of participants experiencing either symptomatic DVT, non-fatal PE, VTE related death adjudicated by a blinded independent CEC between randomization and on or before Visit 3 or Day 42 if patient did not have a Visit 3, or a blinded ultrasound core laboratory measuring of asymptomatic proximal DVT between randomization and Day 47. Visit 3 is between day 35-42 after randomization (day 1).
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Timepoint [3]
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mITT: Between randomization and Day 47 (max)
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Primary outcome [4]
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Percentage of Participants Experiencing Major Bleeding Through Seven Days After Discontinuation of All Study Medication
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Assessment method [4]
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Percentage of participants experiencing at least one major bleeding adjudicated by a blinded independent CEC between randomization (day 1) and up to seven days after discontinuation of all study medication.
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Timepoint [4]
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Between randomization and Day 49 (max)
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Secondary outcome [1]
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mITT Cohort 1: Percentage of Participants Experiencing the Composite Event of Symptomatic DVT, Non-fatal PE, or VTE-related Death, Through Visit 3
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Assessment method [1]
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mITT Cohort 1: Percentage of participants experiencing either symptomatic DVT, non-fatal PE, or VTE related death adjudicated by a blinded independent CEC between randomization and on or before Visit 3 or Day 42 if patient did not have a Visit 3. Visit 3 is between day 35-42 after randomization (day 1).
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Timepoint [1]
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mITT Cohort 1: Between randomization and Day 42 (max)
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Secondary outcome [2]
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mITT Cohort 2: Percentage of Participants Experiencing the Composite Event of Symptomatic DVT, Non-fatal PE, or VTE-related Death, Through Visit 3
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Assessment method [2]
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mITT Cohort 2: Percentage of participants experiencing either symptomatic DVT, non-fatal PE, or VTE related death adjudicated by a blinded independent CEC between randomization and on or before Visit 3 or Day 42 if patient did not have a Visit 3. Visit 3 is between day 35-42 after randomization (day 1).
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Timepoint [2]
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mITT Cohort 2: Between randomization and Day 42 (max)
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Secondary outcome [3]
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mITT: Percentage of Participants Experiencing the Composite Event of Symptomatic DVT, Non-fatal PE, or VTE-related Death, Through Visit 3
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Assessment method [3]
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mITT: Percentage of participants experiencing either symptomatic DVT, non-fatal PE, or VTE related death adjudicated by a blinded independent CEC between randomization and on or before Visit 3 or Day 42 if patient did not have a Visit 3. Visit 3 is between day 35-42 after randomization (day 1).
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Timepoint [3]
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mITT: Between randomization and Day 42 (max)
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Eligibility
Key inclusion criteria
* men and non-pregnant, non-breastfeeding women
* anticipated to be severely immobilized for at least 24 hours after randomization
* hospitalized with one of the following
* congestive heart failure
* acute respiratory failure,
* acute infection without septic shock,
* acute rheumatic disorders
* acute ischemic stroke with lower extremity hemiparesis or hemi paralysis
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Minimum age
40
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
* a condition requiring prolonged anticoagulation or anti-platelets
* active bleeding or at high risk of bleeding
* contraindication to anticoagulant therapy
* general conditions in which subjects are not suitable to participate in the study
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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 administering the treatment/s
The people assessing the outcomes
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
1/03/2012
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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
1/01/2016
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Sample size
Target
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Accrual to date
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Final
7513
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Recruitment in Australia
Recruitment state(s)
QLD,SA,WA
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Recruitment hospital [1]
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- Redcliffe
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Recruitment hospital [2]
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- Bedford Park
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Recruitment hospital [3]
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- Nedlands
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- Milton
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Recruitment hospital [5]
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- Parkville
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Recruitment hospital [6]
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- Randwick
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Recruitment hospital [7]
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- Richmond
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Recruitment postcode(s) [1]
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4020 - Redcliffe
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Recruitment postcode(s) [2]
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5042 - Bedford Park
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Recruitment postcode(s) [3]
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6009 - Nedlands
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Qld 4064 - Milton
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Recruitment postcode(s) [5]
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Vic 3050 - Parkville
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Recruitment postcode(s) [6]
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- Randwick
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Recruitment postcode(s) [7]
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Vic 3121 - Richmond
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Recruitment outside Australia
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State/province [113]
0
0
Hellerup
Query!
Country [114]
0
0
Denmark
Query!
State/province [114]
0
0
Hillerod
Query!
Country [115]
0
0
Denmark
Query!
State/province [115]
0
0
Hvidovre
Query!
Country [116]
0
0
Denmark
Query!
State/province [116]
0
0
Kobenhavn NV
Query!
Country [117]
0
0
Denmark
Query!
State/province [117]
0
0
Silkeborg
Query!
Country [118]
0
0
Denmark
Query!
State/province [118]
0
0
Slagelse
Query!
Country [119]
0
0
Estonia
Query!
State/province [119]
0
0
Tallinn
Query!
Country [120]
0
0
Estonia
Query!
State/province [120]
0
0
Tartu
Query!
Country [121]
0
0
Finland
Query!
State/province [121]
0
0
Helsinki
Query!
Country [122]
0
0
Finland
Query!
State/province [122]
0
0
Jyväskylä
Query!
Country [123]
0
0
Finland
Query!
State/province [123]
0
0
Kouvola
Query!
Country [124]
0
0
Finland
Query!
State/province [124]
0
0
Mikkeli
Query!
Country [125]
0
0
Finland
Query!
State/province [125]
0
0
Pori
Query!
Country [126]
0
0
Finland
Query!
State/province [126]
0
0
Tampere
Query!
Country [127]
0
0
Finland
Query!
State/province [127]
0
0
Turku
Query!
Country [128]
0
0
France
Query!
State/province [128]
0
0
Angers
Query!
Country [129]
0
0
France
Query!
State/province [129]
0
0
Arras
Query!
Country [130]
0
0
France
Query!
State/province [130]
0
0
Avignon
Query!
Country [131]
0
0
France
Query!
State/province [131]
0
0
Bois-Guillaume
Query!
Country [132]
0
0
France
Query!
State/province [132]
0
0
Bordeaux
Query!
Country [133]
0
0
France
Query!
State/province [133]
0
0
Brest
Query!
Country [134]
0
0
France
Query!
State/province [134]
0
0
Cambrai
Query!
Country [135]
0
0
France
Query!
State/province [135]
0
0
Castelnau-le-Lez
Query!
Country [136]
0
0
France
Query!
State/province [136]
0
0
Clermont-Ferrand
Query!
Country [137]
0
0
France
Query!
State/province [137]
0
0
Colombes
Query!
Country [138]
0
0
France
Query!
State/province [138]
0
0
Dijon
Query!
Country [139]
0
0
France
Query!
State/province [139]
0
0
La Tronche
Query!
Country [140]
0
0
France
Query!
State/province [140]
0
0
Le Mans
Query!
Country [141]
0
0
France
Query!
State/province [141]
0
0
Lille
Query!
Country [142]
0
0
France
Query!
State/province [142]
0
0
Limoges
Query!
Country [143]
0
0
France
Query!
State/province [143]
0
0
Montpellier
Query!
Country [144]
0
0
France
Query!
State/province [144]
0
0
Nantes
Query!
Country [145]
0
0
France
Query!
State/province [145]
0
0
Nimes
Query!
Country [146]
0
0
France
Query!
State/province [146]
0
0
Paris
Query!
Country [147]
0
0
France
Query!
State/province [147]
0
0
Pierre Benite
Query!
Country [148]
0
0
France
Query!
State/province [148]
0
0
Quimper
Query!
Country [149]
0
0
France
Query!
State/province [149]
0
0
Rennes
Query!
Country [150]
0
0
France
Query!
State/province [150]
0
0
Saint-Priest En Jarrez
Query!
Country [151]
0
0
France
Query!
State/province [151]
0
0
Tourcoing
Query!
Country [152]
0
0
France
Query!
State/province [152]
0
0
Valenciennes
Query!
Country [153]
0
0
France
Query!
State/province [153]
0
0
Vernon
Query!
Country [154]
0
0
Georgia
Query!
State/province [154]
0
0
Tbilisi
Query!
Country [155]
0
0
Germany
Query!
State/province [155]
0
0
Altenburg
Query!
Country [156]
0
0
Germany
Query!
State/province [156]
0
0
Bad Friedrichshall
Query!
Country [157]
0
0
Germany
Query!
State/province [157]
0
0
Berlin
Query!
Country [158]
0
0
Germany
Query!
State/province [158]
0
0
Bonn
Query!
Country [159]
0
0
Germany
Query!
State/province [159]
0
0
Dresden
Query!
Country [160]
0
0
Germany
Query!
State/province [160]
0
0
Essen
Query!
Country [161]
0
0
Germany
Query!
State/province [161]
0
0
Hamburg
Query!
Country [162]
0
0
Germany
Query!
State/province [162]
0
0
Heidelberg
Query!
Country [163]
0
0
Germany
Query!
State/province [163]
0
0
Karlbad
Query!
Country [164]
0
0
Germany
Query!
State/province [164]
0
0
Ludwigshafen
Query!
Country [165]
0
0
Germany
Query!
State/province [165]
0
0
Magdeburg
Query!
Country [166]
0
0
Germany
Query!
State/province [166]
0
0
Mainz
Query!
Country [167]
0
0
Germany
Query!
State/province [167]
0
0
Minden
Query!
Country [168]
0
0
Germany
Query!
State/province [168]
0
0
Möchengladbach
Query!
Country [169]
0
0
Germany
Query!
State/province [169]
0
0
Neuss
Query!
Country [170]
0
0
Germany
Query!
State/province [170]
0
0
Oberhausen
Query!
Country [171]
0
0
Germany
Query!
State/province [171]
0
0
Paderborn
Query!
Country [172]
0
0
Germany
Query!
State/province [172]
0
0
Rüsselsheim
Query!
Country [173]
0
0
Germany
Query!
State/province [173]
0
0
Troisdorf
Query!
Country [174]
0
0
Germany
Query!
State/province [174]
0
0
Weiden
Query!
Country [175]
0
0
Germany
Query!
State/province [175]
0
0
Wesel
Query!
Country [176]
0
0
Germany
Query!
State/province [176]
0
0
Wiesbaden
Query!
Country [177]
0
0
Germany
Query!
State/province [177]
0
0
Witten
Query!
Country [178]
0
0
Hungary
Query!
State/province [178]
0
0
Baja
Query!
Country [179]
0
0
Hungary
Query!
State/province [179]
0
0
Balassagyarmat
Query!
Country [180]
0
0
Hungary
Query!
State/province [180]
0
0
Balatonfüred
Query!
Country [181]
0
0
Hungary
Query!
State/province [181]
0
0
Berettyóújfalu
Query!
Country [182]
0
0
Hungary
Query!
State/province [182]
0
0
Budapest,
Query!
Country [183]
0
0
Hungary
Query!
State/province [183]
0
0
Budapest
Query!
Country [184]
0
0
Hungary
Query!
State/province [184]
0
0
Cegléd
Query!
Country [185]
0
0
Hungary
Query!
State/province [185]
0
0
Debrecen
Query!
Country [186]
0
0
Hungary
Query!
State/province [186]
0
0
Eger
Query!
Country [187]
0
0
Hungary
Query!
State/province [187]
0
0
Gyula
Query!
Country [188]
0
0
Hungary
Query!
State/province [188]
0
0
Hódmezövásárhely
Query!
Country [189]
0
0
Hungary
Query!
State/province [189]
0
0
Kistarcsa
Query!
Country [190]
0
0
Hungary
Query!
State/province [190]
0
0
Mohács
Query!
Country [191]
0
0
Hungary
Query!
State/province [191]
0
0
Nagykanizsa
Query!
Country [192]
0
0
Hungary
Query!
State/province [192]
0
0
Szekszárd
Query!
Country [193]
0
0
Hungary
Query!
State/province [193]
0
0
Szolnok
Query!
Country [194]
0
0
Hungary
Query!
State/province [194]
0
0
Veszprém
Query!
Country [195]
0
0
Hungary
Query!
State/province [195]
0
0
Zalaegerszeg
Query!
Country [196]
0
0
Israel
Query!
State/province [196]
0
0
Afula
Query!
Country [197]
0
0
Israel
Query!
State/province [197]
0
0
Ashkelon
Query!
Country [198]
0
0
Israel
Query!
State/province [198]
0
0
Haifa
Query!
Country [199]
0
0
Israel
Query!
State/province [199]
0
0
Jerusalem
Query!
Country [200]
0
0
Israel
Query!
State/province [200]
0
0
Kfar Saba
Query!
Country [201]
0
0
Israel
Query!
State/province [201]
0
0
Petach Tikva
Query!
Country [202]
0
0
Israel
Query!
State/province [202]
0
0
Safed
Query!
Country [203]
0
0
Israel
Query!
State/province [203]
0
0
Tel Aviv
Query!
Country [204]
0
0
Israel
Query!
State/province [204]
0
0
Zerifin
Query!
Country [205]
0
0
Italy
Query!
State/province [205]
0
0
Treviso
Query!
Country [206]
0
0
Italy
Query!
State/province [206]
0
0
Bollate
Query!
Country [207]
0
0
Italy
Query!
State/province [207]
0
0
Frenze
Query!
Country [208]
0
0
Italy
Query!
State/province [208]
0
0
Genova
Query!
Country [209]
0
0
Italy
Query!
State/province [209]
0
0
Milano
Query!
Country [210]
0
0
Italy
Query!
State/province [210]
0
0
Napoli
Query!
Country [211]
0
0
Italy
Query!
State/province [211]
0
0
Parma
Query!
Country [212]
0
0
Italy
Query!
State/province [212]
0
0
Pavia
Query!
Country [213]
0
0
Italy
Query!
State/province [213]
0
0
Piacenza
Query!
Country [214]
0
0
Italy
Query!
State/province [214]
0
0
Reggio Emilia
Query!
Country [215]
0
0
Italy
Query!
State/province [215]
0
0
Roma
Query!
Country [216]
0
0
Italy
Query!
State/province [216]
0
0
Varese
Query!
Country [217]
0
0
Italy
Query!
State/province [217]
0
0
Venezia
Query!
Country [218]
0
0
Italy
Query!
State/province [218]
0
0
Vittorio Veneto TV
Query!
Country [219]
0
0
Latvia
Query!
State/province [219]
0
0
Daugavpils
Query!
Country [220]
0
0
Latvia
Query!
State/province [220]
0
0
Liepaja
Query!
Country [221]
0
0
Latvia
Query!
State/province [221]
0
0
Riga
Query!
Country [222]
0
0
Latvia
Query!
State/province [222]
0
0
Valmiera
Query!
Country [223]
0
0
Lithuania
Query!
State/province [223]
0
0
Alytus
Query!
Country [224]
0
0
Lithuania
Query!
State/province [224]
0
0
Kaunas
Query!
Country [225]
0
0
Lithuania
Query!
State/province [225]
0
0
Klaipeda
Query!
Country [226]
0
0
Lithuania
Query!
State/province [226]
0
0
Siauliai
Query!
Country [227]
0
0
Lithuania
Query!
State/province [227]
0
0
Utena
Query!
Country [228]
0
0
Lithuania
Query!
State/province [228]
0
0
Vilnius
Query!
Country [229]
0
0
Montserrat
Query!
State/province [229]
0
0
MS
Query!
Country [230]
0
0
Peru
Query!
State/province [230]
0
0
Arequipa
Query!
Country [231]
0
0
Peru
Query!
State/province [231]
0
0
Callao
Query!
Country [232]
0
0
Peru
Query!
State/province [232]
0
0
Lima
Query!
Country [233]
0
0
Poland
Query!
State/province [233]
0
0
Bialystok
Query!
Country [234]
0
0
Poland
Query!
State/province [234]
0
0
Bydgoszcz
Query!
Country [235]
0
0
Poland
Query!
State/province [235]
0
0
Czeladz
Query!
Country [236]
0
0
Poland
Query!
State/province [236]
0
0
Gdansk
Query!
Country [237]
0
0
Poland
Query!
State/province [237]
0
0
Krakow
Query!
Country [238]
0
0
Poland
Query!
State/province [238]
0
0
Skierniewice
Query!
Country [239]
0
0
Poland
Query!
State/province [239]
0
0
Tarnobrzeg
Query!
Country [240]
0
0
Poland
Query!
State/province [240]
0
0
Warszawa
Query!
Country [241]
0
0
Poland
Query!
State/province [241]
0
0
Wloclawek
Query!
Country [242]
0
0
Romania
Query!
State/province [242]
0
0
Baia
Query!
Country [243]
0
0
Romania
Query!
State/province [243]
0
0
Bucharest
Query!
Country [244]
0
0
Romania
Query!
State/province [244]
0
0
Cluj Napoca
Query!
Country [245]
0
0
Romania
Query!
State/province [245]
0
0
Cluj-Napoca
Query!
Country [246]
0
0
Romania
Query!
State/province [246]
0
0
Craiova
Query!
Country [247]
0
0
Romania
Query!
State/province [247]
0
0
Iasi
Query!
Country [248]
0
0
Romania
Query!
State/province [248]
0
0
Oradea
Query!
Country [249]
0
0
Romania
Query!
State/province [249]
0
0
Pitesti
Query!
Country [250]
0
0
Romania
Query!
State/province [250]
0
0
Targu Mures
Query!
Country [251]
0
0
Romania
Query!
State/province [251]
0
0
Timisoara
Query!
Country [252]
0
0
Russian Federation
Query!
State/province [252]
0
0
Arkhangelsk
Query!
Country [253]
0
0
Russian Federation
Query!
State/province [253]
0
0
Barnaul
Query!
Country [254]
0
0
Russian Federation
Query!
State/province [254]
0
0
Belgorod
Query!
Country [255]
0
0
Russian Federation
Query!
State/province [255]
0
0
Chelyabinsk
Query!
Country [256]
0
0
Russian Federation
Query!
State/province [256]
0
0
Ekaterinburg
Query!
Country [257]
0
0
Russian Federation
Query!
State/province [257]
0
0
Irkutsk
Query!
Country [258]
0
0
Russian Federation
Query!
State/province [258]
0
0
Kaluga
Query!
Country [259]
0
0
Russian Federation
Query!
State/province [259]
0
0
Kazan
Query!
Country [260]
0
0
Russian Federation
Query!
State/province [260]
0
0
Kemerovo
Query!
Country [261]
0
0
Russian Federation
Query!
State/province [261]
0
0
Kirov
Query!
Country [262]
0
0
Russian Federation
Query!
State/province [262]
0
0
Krasnodar
Query!
Country [263]
0
0
Russian Federation
Query!
State/province [263]
0
0
Lubertsy
Query!
Country [264]
0
0
Russian Federation
Query!
State/province [264]
0
0
Moscow
Query!
Country [265]
0
0
Russian Federation
Query!
State/province [265]
0
0
Murmansk
Query!
Country [266]
0
0
Russian Federation
Query!
State/province [266]
0
0
Novosibirsk
Query!
Country [267]
0
0
Russian Federation
Query!
State/province [267]
0
0
Rostov-on-Don
Query!
Country [268]
0
0
Russian Federation
Query!
State/province [268]
0
0
Samara
Query!
Country [269]
0
0
Russian Federation
Query!
State/province [269]
0
0
Saratov
Query!
Country [270]
0
0
Russian Federation
Query!
State/province [270]
0
0
Smolensk
Query!
Country [271]
0
0
Russian Federation
Query!
State/province [271]
0
0
St. Petersburg
Query!
Country [272]
0
0
Russian Federation
Query!
State/province [272]
0
0
St.Petersburg
Query!
Country [273]
0
0
Russian Federation
Query!
State/province [273]
0
0
Tomsk
Query!
Country [274]
0
0
Russian Federation
Query!
State/province [274]
0
0
Yaroslavl
Query!
Country [275]
0
0
Serbia
Query!
State/province [275]
0
0
Belgrade
Query!
Country [276]
0
0
Serbia
Query!
State/province [276]
0
0
Kragujevac
Query!
Country [277]
0
0
Serbia
Query!
State/province [277]
0
0
Niska Banja
Query!
Country [278]
0
0
Serbia
Query!
State/province [278]
0
0
Nis
Query!
Country [279]
0
0
Serbia
Query!
State/province [279]
0
0
Pancevo
Query!
Country [280]
0
0
Serbia
Query!
State/province [280]
0
0
Sremska Kamenica
Query!
Country [281]
0
0
Singapore
Query!
State/province [281]
0
0
Singapore
Query!
Country [282]
0
0
Slovakia
Query!
State/province [282]
0
0
Bratislava
Query!
Country [283]
0
0
Slovakia
Query!
State/province [283]
0
0
Nitra
Query!
Country [284]
0
0
South Africa
Query!
State/province [284]
0
0
Gauteng
Query!
Country [285]
0
0
South Africa
Query!
State/province [285]
0
0
Western Cape
Query!
Country [286]
0
0
South Africa
Query!
State/province [286]
0
0
Pretoria
Query!
Country [287]
0
0
South Africa
Query!
State/province [287]
0
0
Worcester
Query!
Country [288]
0
0
Spain
Query!
State/province [288]
0
0
Cataluña
Query!
Country [289]
0
0
Spain
Query!
State/province [289]
0
0
Communidad De
Query!
Country [290]
0
0
Spain
Query!
State/province [290]
0
0
Comunidad Valenciana
Query!
Country [291]
0
0
Spain
Query!
State/province [291]
0
0
Galicia
Query!
Country [292]
0
0
Spain
Query!
State/province [292]
0
0
Madrid, Communidad De
Query!
Country [293]
0
0
Spain
Query!
State/province [293]
0
0
Barcelona
Query!
Country [294]
0
0
Spain
Query!
State/province [294]
0
0
Cartagena
Query!
Country [295]
0
0
Spain
Query!
State/province [295]
0
0
Girona
Query!
Country [296]
0
0
Spain
Query!
State/province [296]
0
0
Olot
Query!
Country [297]
0
0
Spain
Query!
State/province [297]
0
0
Pontevedra
Query!
Country [298]
0
0
Spain
Query!
State/province [298]
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Funding & Sponsors
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Portola Pharmaceuticals
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Summary
Brief summary
The purpose of this study is to evaluate whether extended prophylaxis with oral betrixaban can prevent blood clots in the leg and lung that sometime occur in patients hospitalized for an acute medical illness and to compare these results with standard of care enoxaparin. The safety of betrixaban will also be studied.
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Trial website
https://clinicaltrials.gov/study/NCT01583218
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Trial related presentations / publications
Jamil A, Jamil U, Singh K, Khan F, Chi G. Extended Thromboprophylaxis With Betrixaban or Rivaroxaban for Acutely Ill Hospitalized Medical Patients: Meta-Analysis of Prespecified Subgroups. Crit Pathw Cardiol. 2021 Mar 1;20(1):16-24. doi: 10.1097/HPC.0000000000000232. Yee MK, Gibson CM, Nafee T, Kerneis M, Daaboul Y, Korjian S, Chi G, AlKhalfan F, Hernandez AF, Hull RD, Cohen AT, Goldhaber SZ. Characterization of Major and Clinically Relevant Non-Major Bleeds in the APEX Trial. TH Open. 2019 Apr 17;3(2):e103-e108. doi: 10.1055/s-0039-1685496. eCollection 2019 Apr. Guy H, Laskier V, Fisher M, Bucior I, Deitelzweig S, Cohen AT. Budget impact analysis of betrixaban for venous thromboembolism prophylaxis in nonsurgical patients with acute medical illness in the United Kingdom. Expert Rev Pharmacoecon Outcomes Res. 2020 Jun;20(3):259-267. doi: 10.1080/14737167.2019.1629905. Epub 2019 Jun 19. Chi G, Gibson CM, Kalayci A, Cohen AT, Hernandez AF, Hull RD, Kahe F, Jafarizade M, Sharfaei S, Liu Y, Harrington RA, Goldhaber SZ. Extended-duration betrixaban versus shorter-duration enoxaparin for venous thromboembolism prophylaxis in critically ill medical patients: an APEX trial substudy. Intensive Care Med. 2019 Apr;45(4):477-487. doi: 10.1007/s00134-019-05565-6. Epub 2019 Feb 18. Kalayci A, Gibson CM, Chi G, Yee MK, Korjian S, Datta S, Nafee T, Gurin M, Haroian N, Qamar I, Hull RD, Hernandez AF, Cohen AT, Harrington RA, Goldhaber SZ. Asymptomatic Deep Vein Thrombosis is Associated with an Increased Risk of Death: Insights from the APEX Trial. Thromb Haemost. 2018 Dec;118(12):2046-2052. doi: 10.1055/s-0038-1675606. Epub 2018 Nov 12. Chi G, Gibson CM, Liu Y, Hernandez AF, Hull RD, Cohen AT, Harrington RA, Goldhaber SZ. Inverse relationship of serum albumin to the risk of venous thromboembolism among acutely ill hospitalized patients: Analysis from the APEX trial. Am J Hematol. 2019 Jan;94(1):21-28. doi: 10.1002/ajh.25296. Epub 2018 Oct 17. Chi G, Goldhaber SZ, Hull RD, Hernandez AF, Kerneis M, Al Khalfan F, Cohen AT, Harrington RA, Gibson CM. Thrombus Burden of Deep Vein Thrombosis and Its Association with Thromboprophylaxis and D-Dimer Measurement: Insights from the APEX Trial. Thromb Haemost. 2017 Dec;117(12):2389-2395. doi: 10.1160/TH17-08-0538. Epub 2017 Dec 6. Yee MK, Nafee T, Daaboul Y, Korjian S, AlKhalfan F, Kerneis M, Wiest C, Goldhaber SZ, Hernandez AF, Hull RD, Cohen AT, Harrington RA, Gibson CM. Increased benefit of betrixaban among patients with a history of venous thromboembolism: a post-hoc analysis of the APEX trial. J Thromb Thrombolysis. 2018 Jan;45(1):1-8. doi: 10.1007/s11239-017-1583-0. Chi G, Januzzi JL, Korjian S, Daaboul Y, Goldhaber SZ, Hernandez AF, Hull RD, Gold A, Cohen AT, Harrington RA, Gibson CM. N-terminal pro-B-type natriuretic peptide and the risk of stroke among patients hospitalized with acute heart failure: an APEX trial substudy. J Thromb Thrombolysis. 2017 Nov;44(4):457-465. doi: 10.1007/s11239-017-1552-7. Arbetter DF, Jain P, Yee MK, Michalak N, Hernandez AF, Hull RD, Goldhaber SZ, Harrington RA, Gold A, Cohen AT, Gibson CM. Competing risk analysis in a large cardiovascular clinical trial: An APEX substudy. Pharm Stat. 2017 Nov;16(6):445-450. doi: 10.1002/pst.1823. Epub 2017 Aug 24. Chi G, Goldhaber SZ, Kittelson JM, Turpie AGG, Hernandez AF, Hull RD, Gold A, Curnutte JT, Cohen AT, Harrington RA, Gibson CM. Effect of extended-duration thromboprophylaxis on venous thromboembolism and major bleeding among acutely ill hospitalized medical patients: a bivariate analysis. J Thromb Haemost. 2017 Oct;15(10):1913-1922. doi: 10.1111/jth.13783. Epub 2017 Sep 4. Gibson CM, Korjian S, Chi G, Daaboul Y, Jain P, Arbetter D, Goldhaber SZ, Hull R, Hernandez AF, Lopes RD, Gold A, Cohen AT, Harrington RA; APEX Investigators. Comparison of Fatal or Irreversible Events With Extended-Duration Betrixaban Versus Standard Dose Enoxaparin in Acutely Ill Medical Patients: An APEX Trial Substudy. J Am Heart Assoc. 2017 Jul 11;6(7):e006015. doi: 10.1161/JAHA.117.006015. Gibson CM, Goldhaber SZ, Cohen AT, Nafee T, Hernandez AF, Hull R, Korjian S, Daaboul Y, Chi G, Yee M, Harrington RA. When academic research organizations and clinical research organizations disagree: Processes to minimize discrepancies prior to unblinding of randomized trials. Am Heart J. 2017 Jul;189:1-8. doi: 10.1016/j.ahj.2017.03.018. Epub 2017 Mar 31. No abstract available. Marszalek J, Mehrsefat S, Chi G. The risk of stroke among acutely ill hospitalized medical patients: lessons from recent trials on extended-duration thromboprophylaxis. Expert Rev Hematol. 2017 Aug;10(8):679-684. doi: 10.1080/17474086.2017.1343662. Epub 2017 Jun 21. Gibson CM, Chi G, Halaby R, Korjian S, Daaboul Y, Jain P, Arbetter D, Goldhaber SZ, Hull R, Hernandez AF, Gold A, Bandman O, Harrington RA, Cohen AT; APEX Investigators. Extended-Duration Betrixaban Reduces the Risk of Stroke Versus Standard-Dose Enoxaparin Among Hospitalized Medically Ill Patients: An APEX Trial Substudy (Acute Medically Ill Venous Thromboembolism Prevention With Extended Duration Betrixaban). Circulation. 2017 Feb 14;135(7):648-655. doi: 10.1161/CIRCULATIONAHA.116.025427. Epub 2016 Nov 14. Cohen AT, Harrington RA, Goldhaber SZ, Hull RD, Wiens BL, Gold A, Hernandez AF, Gibson CM; APEX Investigators. Extended Thromboprophylaxis with Betrixaban in Acutely Ill Medical Patients. N Engl J Med. 2016 Aug 11;375(6):534-44. doi: 10.1056/NEJMoa1601747. Epub 2016 May 27. Cohen AT, Harrington R, Goldhaber SZ, Hull R, Gibson CM, Hernandez AF, Kitt MM, Lorenz TJ. The design and rationale for the Acute Medically Ill Venous Thromboembolism Prevention with Extended Duration Betrixaban (APEX) study. Am Heart J. 2014 Mar;167(3):335-41. doi: 10.1016/j.ahj.2013.11.006. Epub 2013 Dec 10.
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Results are available at
https://clinicaltrials.gov/study/NCT01583218
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