An Efficacy and Safety Study for Rivaroxaban in Patients With Acute Coronary Syndrome


Tracking Information

Start Date  ICMJENovember 2008
Estimated Primary Completion DateJune 2011   (final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE 
 (submitted: December 16, 2008)		The primary outcome measure is the reduction in the risk of the composite endpoint of CV death, MI, or stroke.
Original Primary Outcome Measures  ICMJESame as current
Change HistoryComplete list of historical versions of study NCT00809965 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE 
 (submitted: December 23, 2008)		Secondary outcome include assessments of the composite of all cause of death, MI, or stroke, assessments of the composite primary endpoint including severe recurrent ischemia and the net clinical outcome (the composite of efficacy and safety endpoints).
Original Secondary Outcome Measures  ICMJE 
 (submitted: December 16, 2008)		Secondary outcome include assessments of the composite of all cause of death, MI, or stroke, assessments of the composite primary endpoint including severe recurent ischemia and the net clinical outcome (the composite of efficacy and safety endpoints).

Descriptive Information

Brief Title  ICMJEAn Efficacy and Safety Study for Rivaroxaban in Patients With Acute Coronary Syndrome.
Official Title  ICMJEA 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
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 subjects 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 subjects 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.

Study PhasePhase III
Study Type  ICMJEInterventional
Study Design  ICMJETreatment, Randomized, Double-Blind, Single Group Assignment, Safety/Efficacy Study
Condition  ICMJE
  • Acute Coronary Syndrome
  • Myocardial Infarction
  • Myocardial Ischemia
  • Unstable Angina
Intervention  ICMJEDrug: Rivaroxaban; Placebo

Recruitment Information

Estimated Enrollment  ICMJE16000
Estimated Completion DateJune 2011
Estimated Primary Completion DateJune 2011   (final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
GenderBoth
Ages18 Years and older
Accepts Healthy VolunteersNo
Contacts  ICMJE
Contact: Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions:info1@veritasmedicine.com
Location Countries  ICMJEUnited States,   Argentina,   Australia,   Belgium,   Brazil,   Bulgaria,   Canada,   Chile,   China,   Colombia,   Croatia,   Czech Republic,   Denmark,   Egypt,   France,   Germany,   Greece,   Hungary,   India,   Israel,   Japan,   Korea, Republic of,   Latvia,   Lithuania,   Malaysia,   Mexico,   Morocco,   Netherlands,   New Zealand,   Philippines,   Poland,   Portugal,   Romania,   Russian Federation,   Serbia,   Slovakia,   Spain,   Sweden,   Thailand,   Tunisia,   Turkey,   Ukraine,   United Kingdom

Administrative Information

NCT ID  ICMJENCT00809965
Responsible Party 
Study ID Numbers  ICMJECR014710
Study Sponsor  ICMJEJohnson & Johnson Pharmaceutical Research & Development, L.L.C.
Collaborators  ICMJEBayer
Investigators  ICMJE
Study Director:Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical TrialJohnson & Johnson Pharmaceutical Research & Development, L.L.C.
Information Provided ByJohnson & Johnson Pharmaceutical Research & Development, L.L.C.