Status:
COMPLETED
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
Lead Sponsor:
Janssen Research & Development, LLC
Collaborating Sponsors:
Bayer
Duke Clinical Research Institute
Conditions:
Acute Coronary Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 rec...
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 i...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 20 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 14 2016
Estimated Enrollment :
3037 Patients enrolled
Trial Details
Trial ID
NCT02293395
Start Date
April 20 2015
End Date
October 14 2016
Last Update
December 26 2017
Active Locations (259)
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1
Alexander City, Alabama, United States
2
Banning, California, United States
3
Sylmar, California, United States
4
Aurora, Colorado, United States