Clinical trial NCT00809965: An Efficacy and Safety Study for Rivaroxaban in Patients With Acute Coronary Syndrome
Official title: A Randomized, Double-Blind, Placebo-Controlled, Event-Driven Multicenter Study to Evaluate the Efficacy and Safety of Rivaroxaban in Subjects With a Recent Acute Coronary Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acute Coronary Syndrome
Myocardial Infarction
Myocardial Ischemia
Unstable Angina
Keywords: Rivaroxaban
Acute Coronary Syndrome
ACS
Aspirin
Thienopyridine
Unstable Angina
Myocardial Infarction
Anticoagulation
Clopidogrel (Plavix)
Lead sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Sponsor class: INDUSTRY
Collaborators: name: Bayer
First posted: 2008-12-17
Enrollment: 15526
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether rivaroxaban in addition to standard care reduces the risk of the composite of cardiovascular death, myocardial infarction, or stroke in patients with a recent acute coronary syndrome compared with placebo.

Detailed description: Acute coronary syndrome (ACS) is a serious and life threatening condition. Following an acute coronary syndrome event patients are at risk of important additional clinical events such as death, myocardial infarction, and stroke. Six months after patients present with an index event of ST-segment myocardial infarction, approximately 15% will either have died or had another episode of myocardial ischemia, and a similar situation exists for non-ST-segment elevation myocardial infarction/unstable angina patients. This randomized; double-blind; placebo controlled study will evaluate the efficacy and safety of rivaroxaban in addition to standard care in patients with a recent ACS. Patients will be given rivaroxaban (2.5 mg twice daily or 5 mg twice daily) or placebo (twice daily) in addition to standard care.

Eligibility criteria: Inclusion Criteria:

* Patients must be currently receiving aspirin therapy alone or in combination with a thienopyridine per national or local dosing recommendation
* Have been hospitalized for symptoms suggestive of acute coronary syndrome that lasted at least 10 minutes at rest and occurred 48 hours or less before going to the hospital

Exclusion Criteria:

* Any condition that, in the opinion of the investigator, contraindicates anticoagulant therapy or would have an unacceptable risk of bleeding
* Need for continued anticoagulant therapy
* Significant renal impairment or known significant liver disease

Primary outcomes:
measure: The Percentage of Patients With the Composite Endpoint of Cardiovascular Death, Myocardial Infarction, or Stroke
timeFrame: From the time of randomization (Day 1) up to completion of the treatment phase (Month 6)
Secondary outcomes:
measure: The Percentage of Patients With the Composite of All Cause Death, Myocardial Infarction, or Stroke
timeFrame: From the time of randomization (Day 1) up to completion of the treatment phase (Month 6)
measure: The Percentage of Patients With the Composite of Cardiovascular Death, Myocardial Infarction, Ischemic Stroke, or TIMI Major Bleeding Event Not Associated With Coronary Artery Bypass Graft Surgery
timeFrame: From the time of randomization (Day 1) up to completion of the treatment phase (Month 6)
measure: The Percentage of Patients With the Composite of Cardiovascular Death, Myocardial Infarction, Stroke, or Severe Recurrent Ischemia Requiring Revascularization
timeFrame: From the time of randomization (Day 1) up to completion of the treatment phase (Month 6)
measure: The Percentage of Patients With the Composite of Cardiovascular Death, Myocardial Infarction, Stroke, or Severe Recurrent Ischemia Leading to Hospitalization
timeFrame: From the time of randomization (Day 1) up to completion of the treatment phase (Month 6)
Other outcomes:
Locations:
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country: United States
state: Alabama
city: Geneva
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state: Alabama
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city: Burbank
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city: Krasnoyarsk
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city: Lyubertsy
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country: Russian Federation
city: Moscow
country: Russian Federation
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country: Russian Federation
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country: Russian Federation
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country: Russian Federation
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country: Russian Federation
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country: Russian Federation
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country: Russian Federation
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country: Russian Federation
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country: Russian Federation
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country: Russian Federation
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country: Russian Federation
city: Saint-Petersburg
country: Russian Federation
city: Sestroretsk, Saint-Petersburg
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country: Russian Federation
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country: Russian Federation
city: St. Petersburg
country: Russian Federation
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country: Spain
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country: Spain
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country: Spain
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country: Spain
city: Huelva N/A
country: Spain
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country: Spain
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country: Spain
city: Málaga
country: Spain
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country: Spain
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city: Tunis
country: Tunisia
city: Ankara
country: Turkey
city: Aydin
country: Turkey
city: Bursa
country: Turkey
city: Erzurum
country: Turkey
city: Istanbul
country: Turkey
city: Izmir
country: Turkey
city: Kayseri
country: Turkey
city: Samsun
country: Turkey
city: Sivas
country: Turkey
city: Cherkassy
country: Ukraine
city: Dnepropetrovsk
country: Ukraine
city: Donetsk
country: Ukraine
city: Ivano-Frankivsk
country: Ukraine
city: Kharkov
country: Ukraine
city: Khemelnitskiy
country: Ukraine
city: Kiev
country: Ukraine
city: Lugansk
country: Ukraine
city: Lutsk
country: Ukraine
city: Lviv
country: Ukraine
city: Nikolaev
country: Ukraine
city: Poltava
country: Ukraine
city: Sumy
country: Ukraine
city: Ternopol
country: Ukraine
city: Uzhgorod
country: Ukraine
city: Vinnitsa
country: Ukraine
city: Zaporozhye
country: Ukraine
city: Zhytomir
country: Ukraine
city: Birmingham
country: United Kingdom
city: Blackpool
country: United Kingdom
city: Bristol
country: United Kingdom
city: Chertsey
country: United Kingdom
city: Chesterfield
country: United Kingdom
city: East Sussex
country: United Kingdom
city: Exeter
country: United Kingdom
city: Hampshire
country: United Kingdom
city: Harrow
country: United Kingdom
city: Hull
country: United Kingdom
city: Leicester
country: United Kingdom
city: Lincoln
country: United Kingdom
city: Manchester
country: United Kingdom
city: Middlesbrough
country: United Kingdom
city: Portadown
country: United Kingdom
city: Stockport
country: United Kingdom
city: Warwick
country: United Kingdom
city: Worcester
country: United Kingdom
Study officials:
affiliation: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
name: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
role: STUDY_DIRECTOR
References:
citation: Gibson WJ, Nafee T, Travis R, Yee M, Kerneis M, Ohman M, Gibson CM. Machine learning versus traditional risk stratification methods in acute coronary syndrome: a pooled randomized clinical trial analysis. J Thromb Thrombolysis. 2020 Jan;49(1):1-9. doi: 10.1007/s11239-019-01940-8.
citation: Gibson CM, Levitan B, Gibson WJ, Yee MK, Murphy SA, Yuan Z, Chakrabarti AK, Lee M, Braunwald E. Fatal or Irreversible Bleeding and Ischemic Events With Rivaroxaban in Acute Coronary Syndrome. J Am Coll Cardiol. 2018 Jul 10;72(2):129-136. doi: 10.1016/j.jacc.2018.04.055.
citation: Cavender MA, Gibson CM, Braunwald E, Wiviott SD, Murphy SA, Toda Kato E, Plotnikov AN, Amuchastegui M, Oude Ophuis T, van Hessen M, Mega JL. The effect of rivaroxaban on myocardial infarction in the ATLAS ACS 2 - TIMI 51 trial. Eur Heart J Acute Cardiovasc Care. 2015 Oct;4(5):468-74. doi: 10.1177/2048872614554109. Epub 2014 Oct 15.
citation: Gibson CM, Chakrabarti AK, Mega J, Bode C, Bassand JP, Verheugt FW, Bhatt DL, Goto S, Cohen M, Mohanavelu S, Burton P, Stone G, Braunwald E; ATLAS-ACS 2 TIMI 51 Investigators. Reduction of stent thrombosis in patients with acute coronary syndromes treated with rivaroxaban in ATLAS-ACS 2 TIMI 51. J Am Coll Cardiol. 2013 Jul 23;62(4):286-90. doi: 10.1016/j.jacc.2013.03.041. Epub 2013 Apr 16.
citation: Mega JL, Braunwald E, Murphy SA, Plotnikov AN, Burton P, Kiss RG, Parkhomenko A, Tendera M, Widimsky P, Gibson CM. Rivaroxaban in patients stabilized after a ST-segment elevation myocardial infarction: results from the ATLAS ACS-2-TIMI-51 trial (Anti-Xa Therapy to Lower Cardiovascular Events in Addition to Standard Therapy in Subjects with Acute Coronary Syndrome-Thrombolysis In Myocardial Infarction-51). J Am Coll Cardiol. 2013 May 7;61(18):1853-9. doi: 10.1016/j.jacc.2013.01.066. Epub 2013 Mar 7.
citation: Mega JL, Braunwald E, Wiviott SD, Bassand JP, Bhatt DL, Bode C, Burton P, Cohen M, Cook-Bruns N, Fox KA, Goto S, Murphy SA, Plotnikov AN, Schneider D, Sun X, Verheugt FW, Gibson CM; ATLAS ACS 2-TIMI 51 Investigators. Rivaroxaban in patients with a recent acute coronary syndrome. N Engl J Med. 2012 Jan 5;366(1):9-19. doi: 10.1056/NEJMoa1112277. Epub 2011 Nov 13.
citation: Gibson CM, Mega JL, Burton P, Goto S, Verheugt F, Bode C, Plotnikov A, Sun X, Cook-Bruns N, Braunwald E. Rationale and design of the Anti-Xa therapy to lower cardiovascular events in addition to standard therapy in subjects with acute coronary syndrome-thrombolysis in myocardial infarction 51 (ATLAS-ACS 2 TIMI 51) trial: a randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of rivaroxaban in subjects with acute coronary syndrome. Am Heart J. 2011 May;161(5):815-821.e6. doi: 10.1016/j.ahj.2011.01.026.