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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Unstable Angina, Acute Coronary Syndrome, Myocardial Infarction, Myocardial Ischemia

Intervention / Treatment
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* Drug: Rivaroxaban 2.5 mg
* Drug: Rivaroxaban 5 mg
* Drug: Placebo
* Drug: Standard of care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rivaroxaban 2.5 mg bid<br>One 2.5 mg rivaroxaban tablet twice daily for up to 6 months | Drug: Rivaroxaban 2.5 mg<br>* One tablet twice daily<br>Drug: Standard of care<br> <br> |
| Experimental: Rivaroxaban 5 mg bid<br>One 5 mg rivaroxaban tablet twice daily for up to 6 months | Drug: Rivaroxaban 5 mg<br>* One tablet twice daily<br>Drug: Standard of care<br> <br> |
| Placebo Comparator: Placebo<br>One placebo tablet twice daily for up to 6 months | Drug: Placebo<br>* One placebo tablet twice daily<br>Drug: Standard of care<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Percentage of Patients With the Composite Endpoint of Cardiovascular Death, Myocardial Infarction, or Stroke | 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. | From the time of randomization (Day 1) up to completion of the treatment phase (Month 6) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Percentage of Patients With the Composite of All Cause Death, Myocardial Infarction, or Stroke | 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. | From the time of randomization (Day 1) up to completion of the treatment phase (Month 6) | 
| 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 | 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. | From the time of randomization (Day 1) up to completion of the treatment phase (Month 6) | 
| The Percentage of Patients With the Composite of Cardiovascular Death, Myocardial Infarction, Stroke, or Severe Recurrent Ischemia Requiring Revascularization | 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. | From the time of randomization (Day 1) up to completion of the treatment phase (Month 6) | 
| The Percentage of Patients With the Composite of Cardiovascular Death, Myocardial Infarction, Stroke, or Severe Recurrent Ischemia Leading to Hospitalization | 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. | From the time of randomization (Day 1) up to completion of the treatment phase (Month 6) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rivaroxaban, Acute Coronary Syndrome, ACS, Aspirin, Thienopyridine, Unstable Angina, Myocardial Infarction, Anticoagulation, Clopidogrel (Plavix)