Gemini

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

Gemini [NCT02293395]

Description: 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]).


Drug: Acetylsalicylic acid; Drug: Rivaroxaban; Drug: Clopidogrel; Drug: Ticagrelor

Primary Investigator: Sarembock

Drug/Device Information
To evaluate the safety and efficacy of rivaroxaban ASA, in addition to a single antiplatelet agent, for a minimum of 180 days, and up to 360 days of treatment, in subjects with recent ACS
Doses: rivaroxaban 2.5 mg twice daily, ASA 100 mg once daily, clopidogrel 75 mg once daily and ticagrelor 90 mg twice daily
Rivaroxaban has been characterized as a potent and highly selective oral direct FXa inhibitor
Subjects receiving clopidogrel background therapy will be randomly assigned in a 1:1 ratio to either ASA or rivaroxaban, and will continue the background therapy of clopidogrel
Subjects receiving ticagrelor background therapy will be randomly assigned in a 1:1 ratio to either ASA or rivaroxaban, and will continue the background therapy of ticagrelor
Janssen Research & Development, LLC
Major Inclusion and Exclusion
Must have symptoms suggestive of ACS and a diagnosis of STEMI or NSTE-ACS
Subject who is 54 years of age or younger must also have either diabetes mellitus or a history of a prior MI
Subject has any conditions that, in the opinion of the investigator, contraindicates anticoagulant therapy or would have an unacceptable risk of bleeding
Subject who received thrombolytic therapy as treatment for the index ACS event cannot be enrolled in the ticagrelor stratum
No anticipated need for chronic (more than 4 weeks) therapy with NSAIDs