Phase 3
N=15,526
An Efficacy and Safety Study for Rivaroxaban in Patients With Acute Coronary Syndrome
Acute Coronary Syndrome · Myocardial Infarction · Myocardial Ischemia · Unstable Angina
Bottom Line
View on ClinicalTrials.gov: NCT00809965 ↗Enrolled (actual)
15,526
Serious AEs
20.4%
Results posted
Jun 2014
Primary outcome: Primary: The Percentage of Patients With the Composite Endpoint of Cardiovascular Death, Myocardial Infarction, or Stroke — 7.4; 6.1; 6.1 Percentage of patients — p=0.020
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Rivaroxaban 2.5 mg (Drug); Rivaroxaban 5 mg (Drug); Placebo (Drug); Standard of care (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- Primary completion
- Sep 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Percentage of Patients With the Composite Endpoint of Cardiovascular Death, Myocardial Infarction, or Stroke |
7.4; 6.1; 6.1 | 0.020 sig |
| SECONDARY The Percentage of Patients With the Composite of All Cause Death, Myocardial Infarction, or Stroke |
7.5; 6.3; 6.3 | 0.016 sig |
| SECONDARY 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 |
7.6; 7.1; 7.2 | 0.320 |
| SECONDARY The Percentage of Patients With the Composite of Cardiovascular Death, Myocardial Infarction, Stroke, or Severe Recurrent Ischemia Requiring Revascularization |
9.4; 8.5; 8.2 | 0.185 |
| SECONDARY The Percentage of Patients With the Composite of Cardiovascular Death, Myocardial Infarction, Stroke, or Severe Recurrent Ischemia Leading to Hospitalization |
8.7; 7.3; 7.6 | 0.011 sig |
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.
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
Data sourced from ClinicalTrials.gov (NCT00809965). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.