A randomized trial to compare the safety of rivaroxaban vs aspirin in addition to either clopidogrel or ticagrelor in acute coronary syndrome: The design of the GEMINI-ACS-1 phase II study.

摘要: Dual antiplatelet therapy (DAPT), the combination of aspirin and a P2Y12 inhibitor, given for 12 months remains standard care after presentation with acute coronary syndrome (ACS) because it has been shown to be associated significant reduction in ischemic events compared monotherapy. The factor Xa inhibitor rivaroxaban was composite cardiovascular death, myocardial infarction, stroke, resulted nominal when added background DAPT ATLAS ACS 2-TIMI 51 trial; however, there excessive bleeding this "triple-therapy" approach. inhibition "dual-pathway" approach may an effective therapeutic regimen treatment ACS, known importance stenting intriguing data that anticoagulant clopidogrel patients atrial fibrillation appears attractive option patient population. GEMINI-ACS-1 is prospective, randomized, double-dummy, double-blind, active-controlled trial will assess safety dual antithrombotic (rivaroxaban [2.5 mg twice daily] + inhibitor) as (aspirin [100 mg] within 10 days event 3,000 patients. Patients randomized 1:1 ratio stratified by intended use (clopidogrel 75 daily or ticagrelor 90 daily), 1500 expected each strata. primary end point Thrombolysis Myocardial Infarction clinically (major, minor, requiring medical attention). exploratory efficacy determination stent thrombosis. feasibility conventional recent ACS.