A Study to Compare the Safety of Rivaroxaban Versus Acetylsalicylic Acid in Addition to Either Clopidogrel or Ticagrelor Therapy in Participants With Acute Coronary Syndrome
Condition: Acute Coronary Syndrome
MeSH terms: Acute Coronary Syndrome; Syndrome
Intervention: Acetylsalicylic acid; Rivaroxaban; Clopidogrel; Ticagrelor
Intervention description: ASA 100 mg enteric-coated tablet once daily orally.; Rivaroxaban 2.5 mg tablet twice daily orally.; Clopidogrel 75 mg once daily orally.; Ticagrelor 90 mg twice daily orally.
Intervention MeSH terms: Aspirin; Rivaroxaban; Clopidogrel; Ticagrelor
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 3037.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Acute Coronary Syndrome; Myocardial infarction; Unstable angina; Acetylsalicylic acid; Rivaroxaban; JNJ-39039039; Bay 59-7939; Xarelto; Clopidogrel; Ticagrelor; Plavix; Brilinta; Effient

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]).
    

Eligibility 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:

          -  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