Clinical trial NCT01583218: Acute Medically Ill VTE Prevention With Extended Duration Betrixaban Study (The APEX Study)
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Venous Thromboembolism (VTE)
Keywords: Phase III
Lead sponsor: Alexion Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2012-04-23
Enrollment: 7513
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

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

Primary outcomes:
measure: 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
timeFrame: mITT Cohort 1: Between randomization and Day 47 (max)
measure: 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
timeFrame: mITT Cohort 2: Between randomization and Day 47 (max)
measure: mITT: Percentage of Participants Experiencing the Composite Event of Symptomatic DVT, Non-fatal PE, VTE-related Death, or Asymptomatic Proximal DVT, Through Visit 3
timeFrame: mITT: Between randomization and Day 47 (max)
measure: Percentage of Participants Experiencing Major Bleeding Through Seven Days After Discontinuation of All Study Medication
timeFrame: Between randomization and Day 49 (max)
Secondary outcomes:
measure: mITT Cohort 1: Percentage of Participants Experiencing the Composite Event of Symptomatic DVT, Non-fatal PE, or VTE-related Death, Through Visit 3
timeFrame: mITT Cohort 1: Between randomization and Day 42 (max)
measure: mITT Cohort 2: Percentage of Participants Experiencing the Composite Event of Symptomatic DVT, Non-fatal PE, or VTE-related Death, Through Visit 3
timeFrame: mITT Cohort 2: Between randomization and Day 42 (max)
measure: mITT: Percentage of Participants Experiencing the Composite Event of Symptomatic DVT, Non-fatal PE, or VTE-related Death, Through Visit 3
timeFrame: mITT: Between randomization and Day 42 (max)
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Bakersfield
country: United States
state: California
city: Fresno
country: United States
state: California
city: La Mesa
country: United States
state: California
city: Long Beach
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state: California
city: Los Angeles
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state: California
city: Modesto
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state: California
city: San Diego
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state: California
city: Stanford
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state: California
city: Torrance
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state: California
city: Englewood
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state: Colorado
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city: Pensacola
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city: Sarasota
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state: Florida
city: Vero Beach
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city: Columbus
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state: Georgia
city: Decatur
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state: Illinois
city: Oak Park
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city: Carmel
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city: Windsor Heights
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city: Pierre Benite
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city: Saint-Priest En Jarrez
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city: Tourcoing
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city: Vittorio Veneto TV
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city: Daugavpils
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city: Liepaja
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city: Riga
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city: Klaipeda
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state: MS
city: Arequipa
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city: Lima
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city: Lima
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city: Bialystok
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city: Bydgoszcz
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city: Bydgoszcz
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city: Gdansk
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city: Baia
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city: Cluj Napoca
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city: Cluj-Napoca
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city: Arkhangelsk
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city: Novosibirsk
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city: Novosibirsk
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city: Rostov-on-Don
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city: Samara
country: Russian Federation
city: Saratov
country: Russian Federation
city: Saratov
country: Russian Federation
city: Saratov
country: Russian Federation
city: Smolensk
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city: St. Petersburg
country: Russian Federation
city: St. Petersburg
country: Russian Federation
city: St. Petersburg
country: Russian Federation
city: St. Petersburg
country: Russian Federation
city: St. Petersburg
country: Russian Federation
city: St.Petersburg
country: Russian Federation
city: Tomsk
country: Russian Federation
city: Yaroslavl
country: Russian Federation
city: Yaroslavl
country: Russian Federation
city: Belgrade
country: Serbia
city: Kragujevac
country: Serbia
city: Niska Banja
country: Serbia
city: Nis
country: Serbia
city: Pancevo
country: Serbia
city: Sremska Kamenica
country: Serbia
city: Singapore
country: Singapore
city: Singapore
country: Singapore
city: Singapore
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city: Bratislava
country: Slovakia
city: Nitra
country: Slovakia
city: Nitra
country: Slovakia
city: Johannesburg
country: South Africa
state: Gauteng
city: Johannesburg
country: South Africa
state: Gauteng
city: Cape Town
country: South Africa
state: Western Cape
city: Pretoria
country: South Africa
city: Worcester
country: South Africa
city: Barcelona
country: Spain
state: Cataluña
city: Barcelona
country: Spain
state: Cataluña
city: L'Hospitalet de Llobregat
country: Spain
state: Cataluña
city: Sabadell
country: Spain
state: Cataluña
city: Sant Boi de Llobregat
country: Spain
state: Cataluña
city: Tarragona
country: Spain
state: Cataluña
city: Madrid
country: Spain
state: Communidad De
city: Orihuela
country: Spain
state: Comunidad Valenciana
city: Vigo
country: Spain
state: Galicia
city: Madrid
country: Spain
state: Madrid, Communidad De
city: Majadahonda
country: Spain
state: Madrid, Communidad De
city: San Sebastián de los Reyes
country: Spain
state: Madrid, Communidad De
city: Barcelona
country: Spain
city: Barcelona
country: Spain
city: Cartagena
country: Spain
city: Girona
country: Spain
city: Olot
country: Spain
city: Pontevedra
country: Spain
city: Salamanca
country: Spain
city: Terrassa
country: Spain
city: Donetsk
country: Ukraine
city: Donetsk
country: Ukraine
city: Ivano-Frankivsk
country: Ukraine
city: Ivano-Frankivsk
country: Ukraine
city: Kharkiv,
country: Ukraine
city: Kharkiv
country: Ukraine
city: Kharkiv
country: Ukraine
city: Kharkiv
country: Ukraine
city: Kherson
country: Ukraine
city: Kirovograd
country: Ukraine
city: Kyiv
country: Ukraine
city: Kyiv
country: Ukraine
city: Kyiv
country: Ukraine
city: Kyiv
country: Ukraine
city: Kyiv
country: Ukraine
city: Lugansk
country: Ukraine
city: Lutsk
country: Ukraine
city: Lviv
country: Ukraine
city: Odesa
country: Ukraine
city: Odesa
country: Ukraine
city: Odesa
country: Ukraine
city: Rivne
country: Ukraine
city: Simferopol
country: Ukraine
city: Uzhgorod
country: Ukraine
city: Vinnytsya
country: Ukraine
city: Yevpatoriya
country: Ukraine
city: Zaporizhzhya
country: Ukraine
city: Zaporizhzhya
country: Ukraine
city: London
country: United Kingdom
city: London
country: United Kingdom
city: London
country: United Kingdom
city: Manchester
country: United Kingdom
city: Newcastle Upon Tyne
country: United Kingdom
city: Romford
country: United Kingdom
city: Southall
country: United Kingdom
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.