Infarction unstable angina
Conditions
Interventions
PAtient will be assigned rivaroxaban + placebo together with ticagrelor or
clopidogrel ór ASA + placebo togehter with ticagrelor or clopidogrel.
There are 2 treatment groups in this study:
• Rivaroxa
Acute Coronary Syndrome
Anticoagulans
Myocardial Infarction
Unstable Angina
Sponsors
Janssen-Cilag
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: - 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
Exclusion criteria
Exclusion criteria: - 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint of the study is the composite of TIMI clinically significant bleeding events that consists of non CABG-related TIMI major bleeding events, TIMI minor bleeding events, and TIMI bleeding events requiring medical attention. | — |
Secondary
| Measure | Time frame |
|---|---|
| The efficacy of Rivaroxaban compared with ASA, in addition to a single antipletelet agent (clopidogrel or ticagrelor), will be explored, in reducing the risk of the composite of CV death, MI, ischemic stroke and stent thrombosis in subjects with a recent ACS. | — |
Countries
The Netherlands
Outcome results
None listed