Phase 2
N=3,462
Rivaroxaban in Combination With Aspirin Alone or With Aspirin and a Thienopyridine in Patients With Acute Coronary Syndromes (The ATLAS ACS TIMI 46 Trial)
Acute Coronary Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT00402597 ↗Enrolled (actual)
3,462
Serious AEs
21.1%
Results posted
Aug 2012
Primary outcome: Primary: Thrombolysis in Myocardial Infarction (TIMI) Clinically Significant Bleeding Events (Primary Safety) — 36; 17; 109; 43 Patients
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Rivaroxaban/Placebo (Drug); Placebo (Drug); Rivaroxaban (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- Primary completion
- Oct 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Thrombolysis in Myocardial Infarction (TIMI) Clinically Significant Bleeding Events (Primary Safety) |
36; 17; 109; 43; 89 | — |
| PRIMARY The Composite Endpoint of All Cause Death, Myocardial Infarction (MI) (Including Repeat MI), Stroke (Ischemic, Hemorrhagic or Unknown), or Severe Recurrent Ischemia Requiring Revascularization (Primary Efficacy) |
83; 23; 55; 27; 36 | — |
| SECONDARY The Composite Endpoint of Death (All Cause), Myocardial Infarction (MI) (or Repeat MI), or Stroke |
66; 18; 40; 21; 22 | — |
| SECONDARY The Composite Endpoint of Cardiovascular Death, Myocardial Infarction (MI), or Stroke |
63; 18; 40; 21; 21 | — |
| SECONDARY The Number of Deaths (All Cause) |
18; 11; 9; 4; 9 | — |
| SECONDARY The Composite Endpoint of Death (All Cause), MI (or reMI), Stroke, Severe Recurrent Ischemia Requiring Revascularization, or Thrombolysis in Myocardial Infarction (TIMI) (Major or Minor Bleeding) to Assess the Net Clinical Benefit |
88; 24; 71; 35; 48 | — |
Summary
The purpose of this study is to evaluate the safety of rivaroxaban in patients with recent acute coronary syndrome (ACS) and to assess the ability of rivaroxaban to reduce the occurrence of death, myocardial infarction (heart attack), repeat myocardial infarctions, stroke, and ischemia (inadequate blood supply to a local area) in patients with recent ACS.
Eligibility Criteria
Inclusion Criteria
- Have symptoms suggestive of ACS that lasted at least 10 minutes at rest occurring within 7 days of randomization
- Have a diagnosis of ST-elevation myocardial infarction or non-ST elevation myocardial infarction/unstable angina (ie, chest pain or discomfort) (ST elevation is an abnormal finding from an ECG test) with at least 1 protocol-defined high risk feature
Exclusion Criteria
- Active bleeding or high risk of bleeding or intracranial hemorrhage (bleeding within the skull enclosing the brain)
- Need for continued anticoagulant therapy
- Significantly impaired renal (kidney) or hepatic (liver) function
- Severe concomitant diseases such as cardiogenic shock (heart damage that results in insufficient blood supply to other parts or organs of the body), refractory ventricular arrhythmias (irregular contractions of the heart unresponsive to treatment), or any severe condition that would limit life expectancy of the patient to less than 6 months
Data sourced from ClinicalTrials.gov (NCT00402597). 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.