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

Phase 3

Completed

• Conditions: Myocardial Infarction; Myocardial Ischemia; Acute Coronary Syndrome; Unstable Angina
• Interventions: Drug: Rivaroxaban 2.5 mg; Drug: Placebo; Drug: Rivaroxaban 5 mg; Drug: Standard of care

• Registration Number: NCT00809965
• Lead Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

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.

Study Timeline

• Study Start: 2008-11
• Study First Submitted: 2008-12-16
• Study First Submitted QC: 2008-12-16
• Study First Posted: 2008-12-17
• Primary Completion: 2011-09
• Study Completion: 2011-09
• Disposition First Submitted: 2012-10-11
• Disposition First Submitted QC: 2012-10-11
• Disposition First Posted: 2012-10-15
• Results First Submitted: 2014-05-05
• Results First Submitted QC: 2014-05-05
• Results First Posted: 2014-06-02
• Status Verified: 2014-08
• Last Update Submitted: 2014-08-26
• Last Update Posted: 2014-09-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15526

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Rivaroxaban 2.5 mg bid	Standard of care	One 2.5 mg rivaroxaban tablet twice daily for up to 6 months
Rivaroxaban 2.5 mg bid	Rivaroxaban 2.5 mg	One 2.5 mg rivaroxaban tablet twice daily for up to 6 months
Rivaroxaban 5 mg bid	Standard of care	One 5 mg rivaroxaban tablet twice daily for up to 6 months
Placebo	Placebo	One placebo tablet twice daily for up to 6 months
Placebo	Standard of care	One placebo tablet twice daily for up to 6 months
Rivaroxaban 5 mg bid	Rivaroxaban 5 mg	One 5 mg rivaroxaban tablet twice daily for up to 6 months

Primary Outcome Measures

Name	Time	Method
The Percentage of Patients With the Composite Endpoint of Cardiovascular Death, Myocardial Infarction, or Stroke	From the time of randomization (Day 1) up to completion of the treatment phase (Month 6)	The percentage of patients with the first occurrence of the composite of death, myocardial infarction, or stroke. The statistical analysis was based on the time from randomization to the first occurrence of the event while on treatment.

Secondary Outcome Measures

Name	Time	Method
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	From the time of randomization (Day 1) up to completion of the treatment phase (Month 6)	The percentage of patients with the first occurrence of the composite endpoint. The statistical analysis was based on the time from randomization to the first occurrence of the event while on treatment.
The Percentage of Patients With the Composite of Cardiovascular Death, Myocardial Infarction, Stroke, or Severe Recurrent Ischemia Leading to Hospitalization	From the time of randomization (Day 1) up to completion of the treatment phase (Month 6)	The percentage of patients with the first occurrence of the composite endpoint. The statistical analysis was based on the time from randomization to the first occurrence of the event while on treatment.
The Percentage of Patients With the Composite of Cardiovascular Death, Myocardial Infarction, Stroke, or Severe Recurrent Ischemia Requiring Revascularization	From the time of randomization (Day 1) up to completion of the treatment phase (Month 6)	The percentage of patients with the first occurrence of the composite endpoint. The statistical analysis was based on the time from randomization to the first occurrence of the event while on treatment.
The Percentage of Patients With the Composite of All Cause Death, Myocardial Infarction, or Stroke	From the time of randomization (Day 1) up to completion of the treatment phase (Month 6)	The percentage of patients with the first occurrence of the composite endpoint. The statistical analysis was based on the time from randomization to the first occurrence of the event while on treatment.