Acute Medically Ill VTE Prevention With Extended Duration Betrixaban Study (The APEX Study)
APEX
(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
1 other identifier
interventional
7,513
32 countries
452
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Mar 2012
Typical duration for phase_3
452 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2012
CompletedFirst Submitted
Initial submission to the registry
April 16, 2012
CompletedFirst Posted
Study publicly available on registry
April 23, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2016
CompletedResults Posted
Study results publicly available
September 20, 2017
CompletedAugust 7, 2023
August 1, 2023
3.8 years
April 16, 2012
July 19, 2017
August 3, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
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
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).
mITT Cohort 1: Between randomization and Day 47 (max)
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
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).
mITT Cohort 2: Between randomization and Day 47 (max)
mITT: Percentage of Participants Experiencing the Composite Event of Symptomatic DVT, Non-fatal PE, VTE-related Death, or Asymptomatic Proximal DVT, Through Visit 3
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).
mITT: Between randomization and Day 47 (max)
Percentage of Participants Experiencing Major Bleeding Through Seven Days After Discontinuation of All Study Medication
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.
Between randomization and Day 49 (max)
Secondary Outcomes (3)
mITT Cohort 1: Percentage of Participants Experiencing the Composite Event of Symptomatic DVT, Non-fatal PE, or VTE-related Death, Through Visit 3
mITT Cohort 1: Between randomization and Day 42 (max)
mITT Cohort 2: Percentage of Participants Experiencing the Composite Event of Symptomatic DVT, Non-fatal PE, or VTE-related Death, Through Visit 3
mITT Cohort 2: Between randomization and Day 42 (max)
mITT: Percentage of Participants Experiencing the Composite Event of Symptomatic DVT, Non-fatal PE, or VTE-related Death, Through Visit 3
mITT: Between randomization and Day 42 (max)
Study Arms (2)
Betrixaban
EXPERIMENTALDaily oral (PO) betrixaban capsules for 35 to 42 days and subcutaneous (SQ) injections of enoxaparin placebo for 10 ± 4 days
Enoxaparin
ACTIVE COMPARATORDaily subcutaneous (SQ) injections of enoxaparin for 10 ± 4 days and oral (PO) betrixaban placebo capsules for 35 to 42 days
Interventions
Betrixaban 80 mg PO once daily (QD) for 35 day + 7 days. Enoxaparin Placebo: Once daily, 6-14 days
Enoxaparin 40 mg subcutaneous (SC) QD for 10 ± 4 days. Betrixaban Placebo: once daily, 35 days
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (462)
Unknown Facility
Birmingham, Alabama, 35294, United States
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Bakersfield, California, 93308, United States
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Fresno, California, 93701, United States
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La Mesa, California, 91942, United States
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Long Beach, California, 90822, United States
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Los Angeles, California, 90073, United States
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Modesto, California, 95350, United States
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San Diego, California, 92120, United States
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Stanford, California, 94305, United States
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Torrance, California, 90509, United States
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Englewood, Colorado, 80113, United States
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Bay Pines, Florida, 33744, United States
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Clearwater, Florida, 33756, United States
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Jacksonville, Florida, 32216, United States
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Miami, Florida, 33143, United States
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Pensacola, Florida, 32504, United States
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Sarasota, Florida, 34232, United States
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Vero Beach, Florida, 32960, United States
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Columbus, Georgia, 31904, United States
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Decatur, Georgia, 30030, United States
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Chicago, Illinois, 60611, United States
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Oak Park, Illinois, 60302, United States
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Carmel, Indiana, 46032, United States
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Davenport, Iowa, 52803, United States
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Windsor Heights, Iowa, 50324, United States
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Topeka, Kansas, 66604, United States
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Hazard, Kentucky, 41701, United States
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Annapolis, Maryland, 21401, United States
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Baltimore, Maryland, 21287, United States
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Detroit, Michigan, 48202, United States
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Grand Blanc, Michigan, 48439, United States
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Royal Oak, Michigan, 48073, United States
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Troy, Michigan, 48085, United States
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Duluth, Minnesota, 55805, United States
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Picayune, Mississippi, 39466, United States
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Kansas City, Missouri, 64111, United States
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St Louis, Missouri, 63110, United States
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Butte, Montana, 59701, United States
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Omaha, Nebraska, 68131, United States
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Las Vegas, Nevada, 89109, United States
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Reno, Nevada, 89502, United States
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Atlantic City, New Jersey, 08401, United States
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Pomona, New Jersey, 08240, United States
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Somerville, New Jersey, 08876, United States
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Summit, New Jersey, 07901, United States
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Buffalo, New York, 14209, United States
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Manhasset, New York, 11030, United States
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Staten Island, New York, 10305, United States
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Valhalla, New York, 10595, United States
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Durham, North Carolina, 27710, United States
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Cincinnati, Ohio, 45267, United States
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Cleveland, Ohio, 44106-5072, United States
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Columbus, Ohio, 43210, United States
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Camp Hill, Pennsylvania, 17011, United States
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Philadelphia, Pennsylvania, 19107, United States
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Charleston, South Carolina, 29425, United States
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Orangeburg, South Carolina, 29118, United States
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Austin, Texas, 78705, United States
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Austin, Texas, 78752, United States
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Bellaire, Texas, 77401, United States
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Corsicana, Texas, 75110, United States
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Dallas, Texas, 75216, United States
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Fort Worth, Texas, 76104, United States
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Houston, Texas, 77024, United States
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Houston, Texas, 77030, United States
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McAllen, Texas, 78501, United States
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Mission, Texas, 78572, United States
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San Antonio, Texas, 78205, United States
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San Antonio, Texas, 78258, United States
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Victoria, Texas, 77901, United States
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Colchester, Vermont, 05401, United States
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Charlottesville, Virginia, 22908, United States
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Richmond, Virginia, 23249, United States
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Everett, Washington, 98201, United States
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Huntington, West Virginia, 25701, United States
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Buenos Aires, 1280, Argentina
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Buenos Aires, C1181ACH, Argentina
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Coronel Suarez, Buenos Aires, B7540DOL, Argentina
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Corrientes, W3400AMZ, Argentina
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Córdoba, 5000, Argentina
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El Talar, 1618, Argentina
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Rosario, Santa Fe, S2000DSV, Argentina
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San Miguel de Tucumán, T4000JCU, Argentina
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Redcliffe, Queensland, 4020, Australia
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Bedford Park, South Australia, 5042, Australia
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Nedlands, Western Australia, 6009, Australia
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Milton, Qld 4064, Australia
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Parkville, Vic 3050, Australia
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Randwick, Australia
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Richmond, Vic 3121, Australia
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Feldkirch, 6800, Austria
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Gratwein, 8112, Austria
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Graz, 8036, Austria
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Hartberg, 8230, Austria
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Linz, 4020, Austria
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Vienna, 1100, Austria
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Vienna, 1160, Austria
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Zams, 6511, Austria
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Brussels, 1070, Belgium
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Huy, 4500, Belgium
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Leper, 8900, Belgium
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Leuven, 3000, Belgium
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Yvoir, 5530, Belgium
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Belo Horizonte - MG, 30150-221, Brazil
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Botucatu, 18618-970, Brazil
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Brasilia/DF, 70710-905, Brazil
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Brasília, 70710, Brazil
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Campinas, 13083-970, Brazil
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Campinas, Sao Paulo, 13059-740, Brazil
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Curitiba - PR, 80030-001, Brazil
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Porto Alegre, 90620-001, Brazil
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Porto Alegre, 90880-480, Brazil
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Porto Alegre/RS, 90620-001, Brazil
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Salvador, 41810-011, Brazil
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Salvador/BA, 40140-110, Brazil
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Salvador/BA, 41810-011, Brazil
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São José Do Rio Preto- SP, 15090-000, Brazil
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São Paulo, 01308-050, Brazil
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São Paulo, 01323-903, Brazil
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São Paulo, 04012-909, Brazil
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Gabrovo, 5300, Bulgaria
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Pleven, 5800, Bulgaria
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Plovdiv, 4002, Bulgaria
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Sandanski, 2800, Bulgaria
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Sliven, 8800, Bulgaria
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Sofia, 1202, Bulgaria
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Sofia, 1233, Bulgaria
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Sofia, 1407, Bulgaria
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Sofia, 1606, Bulgaria
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Sofia, 1784, Bulgaria
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Sofia, Bulgaria
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Yambol, 8600, Bulgaria
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Edmonton, Alberta, T6K4B3, Canada
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Halifax, Nova Scotia, B3H 3A7, Canada
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Hamilton, Ontario, L8L 2X2, Canada
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Hamilton, Ontario, L8N 4A6, Canada
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Kitchener, Ontario, N2M1B2, Canada
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Ottawa, Ontario, K1H 8L6, Canada
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Thunder Bay, Ontario, P7B 6R4, Canada
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Montreal, Quebec, H1T2M4, Canada
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Ontario, N8X 5A6, Canada
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Québec, G1V 4G5, Canada
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La Serena, 170000, Chile
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Osorno, Chile
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Santiago, 7650568, Chile
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Santiago, Chile
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Temuco, 4781173, Chile
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Viña del Mar, 2570017, Chile
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Krapinske Toplice, 49217, Croatia
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Pula, 52100, Croatia
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Rijeka, 51000, Croatia
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Varaždin, 42000, Croatia
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Zadar, 23000, Croatia
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Zagreb, 10000, Croatia
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Zagreb, 1000, Croatia
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Chrudim, 537 27, Czechia
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Čáslav, 286 01, Czechia
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Hradec Králové, 500 05, Czechia
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Kladno, 272 01, Czechia
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Kroměříž, 76701, Czechia
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Kyjov, 697 33, Czechia
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Liberec, 460 63, Czechia
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Litomyšl, 570 14, Czechia
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Olomouc, 771 11, Czechia
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Ostrava, 703 84, Czechia
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Plzen - Bory, 305 99, Czechia
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Prague, 100 34, Czechia
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Prague, 110 00, Czechia
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Prague, 118 00, Czechia
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Prague, 128 08, Czechia
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Prague, 150 06, Czechia
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Slaný, 274 01, Czechia
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Strakonice, 386 29, Czechia
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Teplice, 415 29, Czechia
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Ústí nad Labem, 401 13, Czechia
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Zlín, 762 75, Czechia
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Znojmo, 669 02, Czechia
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Aarhus N, DK-8200, Denmark
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Frederiksberg, DK-2000, Denmark
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Glostrup Municipality, DK-2600, Denmark
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Haderslev, DK-6100, Denmark
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Hellerup, DK-2900, Denmark
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Hillerød, DK-3400, Denmark
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Hvidovre, DK-2650, Denmark
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København NV, DK-2400, Denmark
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Silkeborg, DK-8600, Denmark
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Slagelse, DK-4200, Denmark
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Tallinn, EE-10138, Estonia
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Tallinn, EE-13419, Estonia
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Tartu, EE-51014, Estonia
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Helsinki, FI-00290, Finland
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Jyväskylä, FI-40620, Finland
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Kouvola, FI-45750, Finland
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Mikkeli, FI-50100, Finland
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Pori, FI-28500, Finland
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Tampere, Finland
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Turku, FI-20520, Finland
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Angers, 49100, France
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Arras, 62022, France
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Avignon, 84918, France
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Bois-Guillaume, 76230, France
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Bordeaux, 33075, France
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Brest, 29200, France
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Brest, 29609, France
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Cambrai, 59400, France
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Castelnau-le-Lez, 34170, France
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Clermont-Ferrand, 63003, France
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Colombes, 92700, France
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Dijon, 21079, France
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La Tronche, 38043, France
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Le Mans, 72037, France
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Lille, 59020, France
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Limoges, 87 042, France
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Montpellier, 34295, France
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Nantes, 44093, France
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Nîmes, 30029 cedex 9, France
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Paris, 75004, France
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Paris, 75010, France
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Paris, 75908, France
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Pierre-Bénite, 69495, France
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Quimper, 29107, France
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Rennes, 35203, France
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Saint-Priest En Jarrez, 42055, France
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Tourcoing, 59200, France
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Valenciennes, 59300, France
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Vernon, 27207, France
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Tbilisi, 0144, Georgia
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Tbilisi, 0159, Georgia
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Tbilisi, 0183, Georgia
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Altenburg, 04600, Germany
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Bad Friedrichshall, 74173, Germany
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Berlin, 10787, Germany
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Bonn, 53115, Germany
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Dresden, 01067, Germany
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Dresden, 01307, Germany
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Essen, 45147, Germany
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Hamburg, 22559, Germany
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Heidelberg, 69120, Germany
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Karlbad, 76307, Germany
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Ludwigshafen, 67063, Germany
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Magdeburg, 39120, Germany
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Mainz, 55131, Germany
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Minden, 32429, Germany
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Möchengladbach, 41063, Germany
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Neuss, 41464, Germany
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Oberhausen, 46045, Germany
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Paderborn, 33098, Germany
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Rüsselsheim am Main, 65428, Germany
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Troisdorf, Germany
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Weiden, 92637, Germany
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Wesel, 46483, Germany
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Wiesbaden, 65199, Germany
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Witten, 58455, Germany
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Baja, 6500, Hungary
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Balassagyarmat, 2660, Hungary
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Balatonfüred, 8231, Hungary
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Berettyóújfalu, 4100, Hungary
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Budapest, 1097, Hungary
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Budapest, 1122, Hungary
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Budapest, 1125, Hungary
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Budapest, 1134, Hungary
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Budapest, 1145, Hungary
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Cegléd, 2700, Hungary
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Debrecen, 4032, Hungary
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Debrecen, H-4012, Hungary
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Eger, 3300, Hungary
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Gyula, 5700, Hungary
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Hódmezövásárhely, 6800, Hungary
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Kistarcsa, 2143, Hungary
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Mohács, 7700, Hungary
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Nagykanizsa, 8800, Hungary
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Szekszárd, 7100, Hungary
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Szolnok, 5000, Hungary
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Veszprém, 8200, Hungary
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Zalaegerszeg, 8900, Hungary
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Afula, 18101, Israel
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Ashkelon, 78278, Israel
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Haifa, 31048, Israel
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Haifa, 31096, Israel
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Jerusalem, 91120, Israel
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Kfar Saba, 44281, Israel
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Petah Tikva, 49100, Israel
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Safed, 13100, Israel
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Tel Aviv, 64239, Israel
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Ẕerifin, 70300, Israel
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Castelfranco Veneto, Treviso, 31033, Italy
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Bollate, 20021, Italy
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Frenze, 50134, Italy
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Genova, 16128, Italy
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Milan, 20085, Italy
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Milan, 20132, Italy
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Napoli, 80131, Italy
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Parma, 43100, Italy
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Pavia, 27100, Italy
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Piacenza, 29121, Italy
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Reggio Emilia, 42100, Italy
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Roma, 00168, Italy
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Varese, 21100, Italy
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Venezia, 30122, Italy
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Vittorio Veneto TV, 31029, Italy
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Daugavpils, LV-5417, Latvia
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Liepāja, LV-3414, Latvia
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Riga, LV-1002, Latvia
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Riga, LV-1038, Latvia
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Valmiera, LV-4201, Latvia
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Alytus, LT-62114, Lithuania
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Kaunas, LT-44320, Lithuania
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Kaunas, LT-45130, Lithuania
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Kaunas, LT-47144, Lithuania
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Klaipėda, LT-92231, Lithuania
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Klaipėda, LT-92288, Lithuania
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Šiauliai, LT-76231, Lithuania
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Utena, 28151, Lithuania
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Vilnius, LT-04130, Lithuania
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Vilnius, LT-08411, Lithuania
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Vilnius, LT-10207, Lithuania
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Picayune, MS, 39466, Montserrat
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Arequipa, 05154, Peru
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Callao, CALLAO 2, Peru
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Lima, 01, Peru
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Lima, 18, Peru
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Lima, Lima 11, Peru
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Lima, LIMA 13, Peru
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Bialystok, 15-276, Poland
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Bydgoszcz, 85-168, Poland
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Bydgoszcz, 85-681, Poland
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Czeladź, 41-250, Poland
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Gdansk, 80-803, Poland
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Krakow, 31-121, Poland
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Krakow, 31-913, Poland
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Skierniewice, 96-100, Poland
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Tarnobrzeg, 39-400, Poland
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Warsaw, 01-138, Poland
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Warsaw, 02-097, Poland
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Włocławek, 87-800, Poland
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Baia, 430031, Romania
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Bucharest, 020475, Romania
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Bucharest, 021659, Romania
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Bucharest, 022328, Romania
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Bucharest, 041915, Romania
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Cluj-Napoca, 400006, Romania
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Cluj-Napoca, 40001, Romania
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Craiova, 200642, Romania
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Iași, 700620, Romania
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Oradea, 410169, Romania
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Piteşti, 110884, Romania
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Târgu Mureş, 540136, Romania
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Timișoara, 300736, Romania
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Arkhangelsk, 163045, Russia
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Barnaul, 656024, Russia
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Barnaul, 656045, Russia
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Belgorod, 308007, Russia
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Chelyabinsk, 454048, Russia
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Chelyabinsk, 454091, Russia
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Irkutsk, 664049, Russia
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Kaluga, 428007, Russia
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Kazan', 420012, Russia
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Kazan', 420043, Russia
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Kemerovo, 650002, Russia
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Kirov, 610014, Russia
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Krasnodar, 350086, Russia
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Lubertsy, 140006, Russia
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Moscow, 111539, Russia
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Moscow, 117292, Russia
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Moscow, 119881, Russia
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Moscow, 119992, Russia
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Moscow, 121552, Russia
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Moscow, 127473, Russia
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Murmansk, 183047, Russia
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Novosibirsk, 630007, Russia
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Novosibirsk, 630051, Russia
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Novosibirsk, 630054, Russia
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Rostov-on-Don, 344022, Russia
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Saint Petersburg, 191025, Russia
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Saint Petersburg, 192242, Russia
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Saint Petersburg, 195067, Russia
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Saint Petersburg, 196247, Russia
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Saint Petersburg, 197022, Russia
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Saint Petersburg, 198205, Russia
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Saint Petersburg, 199106, Russia
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Samara, 443070, Russia
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Saratov, 410028, Russia
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Saratov, 410053, Russia
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Saratov, 410054, Russia
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Smolensk, 214018, Russia
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Tomsk, 643012, Russia
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Yaroslavl, 150003, Russia
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Yaroslavl, 150030, Russia
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Yekaterinburg, 620039, Russia
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Yekaterinburg, 620219, Russia
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Belgrade, 11000, Serbia
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Kamenitz, 21204, Serbia
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Kragujevac, 34000, Serbia
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Niš, 18000, Serbia
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Niška Banja, 18205, Serbia
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Pančevo, 26000, Serbia
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Singapore, 119074, Singapore
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Singapore, 169608, Singapore
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Singapore, 169609, Singapore
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Bratislava, 83305, Slovakia
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Nitra, 949 01, Slovakia
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Nitra, 94901, Slovakia
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Johannesburg, Gauteng, 2021, South Africa
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Johannesburg, Gauteng, 2193, South Africa
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Cape Town, Western Cape, 7530, South Africa
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Pretoria, Gauteng 0084, South Africa
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Worcester, 6850, South Africa
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Barcelona, Catalonia, 08003, Spain
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Barcelona, Catalonia, 08036, Spain
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L'Hospitalet de Llobregat, Catalonia, 08907, Spain
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Sabadell, Catalonia, 08208, Spain
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Sant Boi de Llobregat, Catalonia, '08830, Spain
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Tarragona, Catalonia, 43007, Spain
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Madrid, Communidad de, 28007, Spain
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Vigo, Galicia, 36204, Spain
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Madrid, Madrid, Communidad de, 28034, Spain
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Majadahonda, Madrid, Communidad de, 28222, Spain
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San Sebastián de los Reyes, Madrid, Communidad de, 28702, Spain
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Orihuela, Valencia, 03314, Spain
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Barcelona, 08023, Spain
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Barcelona, 08041, Spain
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Cartagena, 30202, Spain
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Girona, 17007, Spain
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Olot, 17800, Spain
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Pontevedra, 36001, Spain
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Salamanca, 37007, Spain
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Terrassa, 08221, Spain
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Donetsk, 83045, Ukraine
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Donetsk, 83114, Ukraine
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Ivano-Frankivsk, 76008, Ukraine
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Ivano-Frankivsk, Ukraine
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Kharkiv, 61018, Ukraine
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Kharkiv, 61039, Ukraine
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Kharkiv, 61058, Ukraine
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Kharkiv, 61176, Ukraine
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Kherson, 73039, Ukraine
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Kirovograd, 25006, Ukraine
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Kyiv, 01023, Ukraine
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Kyiv, 02091, Ukraine
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Kyiv, 02660, Ukraine
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Kyiv, 03680, Ukraine
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Kyiv, 04060, Ukraine
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Luhansk, 91011, Ukraine
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Lutsk, 43024, Ukraine
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Lviv, 79010, Ukraine
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Odesa, 65009, Ukraine
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Odesa, 65014, Ukraine
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Odesa, 65025, Ukraine
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Rivne, 33001, Ukraine
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Simferopol, 95026, Ukraine
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Uzhhorod, 88000, Ukraine
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Vinnytsia, 21005, Ukraine
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Yevpatoria, 97400, Ukraine
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Zaporizhzhya, 69000, Ukraine
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Zaporizhzhya, 69065, Ukraine
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London, EC1M 6BQ, United Kingdom
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London, SE5 9RS, United Kingdom
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London, WC1E 6HX, United Kingdom
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Manchester, M23 9LT, United Kingdom
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Newcastle upon Tyne, NE7 7DN, United Kingdom
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Romford, RM7 0AG, United Kingdom
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Southall, UB1 3HW, United Kingdom
Related Publications (18)
Chi G, Violi F, Pignatelli P, Vestri A, Spagnoli A, Loffredo L, Hernandez AF, Hull RD, Cohen AT, Harrington RA, Goldhaber SZ, Gibson CM. External validation of the ADA score for predicting thrombosis among acutely ill hospitalized medical patients from the APEX Trial. J Thromb Thrombolysis. 2023 Feb;55(2):211-221. doi: 10.1007/s11239-022-02757-8. Epub 2022 Dec 24.
PMID: 36566304DERIVEDJamil 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.
PMID: 32657973DERIVEDYee 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.
PMID: 31249989DERIVEDGuy 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.
PMID: 31215264DERIVEDChi 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.
PMID: 30778649DERIVEDKalayci 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.
PMID: 30419597DERIVEDChi 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.
PMID: 30252149DERIVEDChi 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.
PMID: 29212126DERIVEDYee 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.
PMID: 29188425DERIVEDChi 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.
PMID: 28905172DERIVEDArbetter 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.
PMID: 28840662DERIVEDChi 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.
PMID: 28762617DERIVEDGibson 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.
PMID: 28698258DERIVEDGibson 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.
PMID: 28625365DERIVEDMarszalek 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.
PMID: 28617144DERIVEDGibson 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.
PMID: 27881569DERIVEDCohen 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.
PMID: 27232649DERIVEDCohen 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.
PMID: 24576517DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Head of Clinical Development
- Organization
- Portola Pharmaceuticals, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 16, 2012
First Posted
April 23, 2012
Study Start
March 1, 2012
Primary Completion
December 1, 2015
Study Completion
January 1, 2016
Last Updated
August 7, 2023
Results First Posted
September 20, 2017
Record last verified: 2023-08