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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
15,526
One tablet twice daily
One tablet twice daily
One placebo tablet twice daily
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.
Time frame: From the time of randomization (Day 1) up to completion of the treatment phase (Month 6)
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.
Time frame: 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.
Time frame: 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.
Time frame: 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
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Unnamed facility
Birmingham, Alabama, United States
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Geneva, Alabama, United States
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Mobile, Alabama, United States
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Anaheim, California, United States
Unnamed facility
Burbank, California, United States
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Los Angeles, California, United States
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Mission Hills, California, United States
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San Diego, California, United States
Unnamed facility
Aurora, Colorado, United States
Unnamed facility
Littleton, Colorado, United States
...and 546 more locations
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.
Time frame: From the time of randomization (Day 1) up to completion of the treatment phase (Month 6)