Clinical trial NCT02293395
Conditions: Acute Coronary Syndrome
Keywords: Acute Coronary Syndrome Myocardial infarction Unstable angina Acetylsalicylic acid Rivaroxaban JNJ-39039039 Bay 59-7939 Xarelto Clopidogrel Ticagrelor Plavix Brilinta Effient
Sponsor: Janssen Research & Development, LLC
Start date: 2015-04-20; Completion date: 2016-10-14
Enrollment: 3037 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to estimate the risk of bleeding with rivaroxaban, compared with acetylsalicylic acid (ASA), in addition to a single antiplatelet/ platelet adenosine diphosphate P2Y12 receptor antagonist (P2Y12 inhibitor agent: clopidogrel or ticagrelor), in participants with a recent acute coronary syndrome (ACS: including ST segment elevation myocardial infarction \[STEMI\] and non-ST-segment elevation acute coronary syndrome \[NSTE-ACS\]).

Detailed description:
This is a prospective, randomized (the study drug is assigned by chance), double-blind (neither physician nor participant knows the treatment that the participant receives), active-controlled (study in which the experimental treatment or procedure is compared to a standard treatment or procedure), parallel group (each group of participants will be treated at the same time), multicenter (when more than one hospital or medical school team work on a medical research study) study in participants with a recent ACS (STEMI or NSTE-ACS). All the eligible participants receiving background treatment of ASA plus clopidogrel (Stratum 1) or ASA plus ticagrelor (Stratum 2) will be randomly assigned to either receive ASA or rivaroxaban on background of P2Y12 receptor antagonists treatment. This study will include 3 phases: Screening Phase (up to 10 days, before study start on Day 1), Double-blind Treatment Phase (up to either 180 days after randomization of the last enrolled participant in the study or Day 360, whichever occurs earlier), and Follow-up Phase (up to 30 days). Participants' safety will be monitored throughout the study.

Arms: arm 1: Acetylsalicylic acid (ASA) 100 milligram (mg) enteric-coated tablet once daily orally along with clopidogrel 75 mg once daily orally, up to either 180 days after randomization of the last enrolled participant in the study or Day 360, whichever occurs earlier. arm 2: Rivaroxaban 2.5 mg tablet twice daily orally along with clopidogrel 75 mg once daily orally, up to either 180 days after randomization of the last enrolled participant in the study or Day 360, whichever occurs earlier. arm 3: ASA 100 mg enteric-coated tablet once daily orally along with ticagrelor 90 mg twice daily orally, up to either 180 days after randomization of the last enrolled participant in the study or Day 360, whichever occurs earlier. arm 4: Rivaroxaban 2.5 mg tablet twice daily orally along with ticagrelor 90 mg twice daily orally, up to either 180 days after randomization of the last enrolled participant in the study or Day 360, whichever occurs earlier.
Interventions: intervention 1: Acetylsalicylic acid intervention 2: Rivaroxaban intervention 3: Clopidogrel intervention 4: Ticagrelor
Intervention descriptions: intervention 1: ASA 100 mg enteric-coated tablet once daily orally. intervention 2: Rivaroxaban 2.5 mg tablet twice daily orally. intervention 3: Clopidogrel 75 mg once daily orally. intervention 4: Ticagrelor 90 mg twice daily orally.

Protocol documents: