A Randomized, Double-blind, Double-dummy, Active-controlled, Parallel-group, Multicenter Study to Compare the Safety of Rivaroxaban versus Acetylsalicylic Acid in Addition to Either Clopidogrel or Ticagrelor Therapy in Subjects with Acute Coronary Syndrome
- Conditions
- Infarctionunstable angina10028593
- Registration Number
- NL-OMON42240
- Lead Sponsor
- Janssen-Cilag
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 130
- Participants, 18 years or older, must have symptoms suggestive of acute coronary syndrome (ACS) (angina, or symptoms thought to be equivalent) within 48 hours of hospital presentation, or developed ACS while being hospitalized, and has a diagnosis of:
a) ST segment elevation myocardial infarction (STEMI);
b) non-ST-segment elevation acute coronary syndrome (NSTE-ACS).
However, participant who is 54 years of age or younger must also have either diabetes mellitus or a history of a prior myocardial infarction (MI), in addition to the presenting ACS event ;- Participant must be randomized within the screening window of 10 days after hospital admission for the index ACS event. Participant should have received acute phase treatment for the index ACS, such as intravenous anticoagulant or antiplatelet, and are receiving maintenance dual antiplatelet therapy (DAPT) with either clopidogrel plus acetyl salicylic acid (ASA), or ticagrelor plus ASA, with the intent to continue the treatment with a platelet adenosine diphosphate P2Y12 receptor antagonist (P2Y12 inhibitor) after randomization;;- Participants must agree to provide a pharmacogenomics deoxyribonucleic acid (DNA) sample
- Participant has any conditions that, in the opinion of the investigator, contraindicates anticoagulant therapy or would have an unacceptable risk;- Participant with a prior stroke of any etiology or transient ischemic attack (TIA);- Participant who received thrombolytic therapy as treatment for the index ACS event cannot be enrolled in the ticagrelor stratum ;- Participant has anticipated need for chronic administration of omeprazole or esomeprazole concomitantly with clopidogrel ;- Participant has known allergy or intolerance to ASA or rivaroxaban
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary endpoint of the study is the composite of TIMI clinically<br /><br>significant bleeding events that<br /><br>consists of non CABG-related TIMI major bleeding events, TIMI minor bleeding<br /><br>events, and TIMI<br /><br>bleeding events requiring medical attention.</p><br>
- Secondary Outcome Measures
Name Time Method <p>The efficacy of Rivaroxaban compared with ASA, in addition to a single<br /><br>antipletelet agent (clopidogrel or ticagrelor), will be explored, in reducing<br /><br>the risk of the composite of CV death, MI, ischemic stroke and stent thrombosis<br /><br>in subjects with a recent ACS.</p><br>