Dabigatran vs. placebo in patients with acute coronary syndromes on dual antiplatelet therapy: a randomized, double-blind, phase II trial

Abstract

Dabigatran, in addition to dual antiplatelet therapy, was associated with a dose-dependent increase in bleeding events and significantly reduced coagulation activity in patients with a recent myocardial infarction.

Apixaban with Antiplatelet Therapy after Acute Coronary Syndrome

“…16,17,35 When added to antiplatelet therapy, both apixaban and riva rox aban resulted in doserelated increases in bleeding but also appeared to result in larger absolute reductions in ischemic events than those seen with placebo. The increases in bleeding were smaller and the reductions in ischemic events were more pronounced among patients taking aspirin alone than among those taking aspirin plus clopidogrel.…”

More, More, More: Reducing Thrombosis in Acute Coronary Syndromes Beyond Dual Antiplatelet Therapy—Current Data and Future Directions

“…The control arms in the reported trials, against which TT was compared, have mostly included patients receiving a combination of aspirin and clopidogrel,21, 22, 23, 28, 29, 30, 31, 45 but current guidelines recommend ticagrelor or prasugrel over clopidogrel in ACS 15, 20, 26, 38. Consequently, any new combination regimen should be compared with “current best.” The combination of a non–vitamin K oral anticoagulant with DAPT that includes these more effective P2Y 12 inhibitors may increase bleeding compared with clopidogrel, but this has never been tested.…”

“…The efficacy and safety of the direct thrombin inhibitor dabigatran was evaluated in RE‐DEEM (Randomized Dabigatran Etexilate Dose Finding Study in Patients With Acute Coronary Syndromes Post Index Event With Additional Risk Factors for Cardiovascular Complications Also Receiving Aspirin and Clopidogrel: Multi‐centre, Prospective, Placebo Controlled, Cohort Dose Escalation Study) 31. This phase II, randomized, double‐blind, placebo‐controlled trial of 1861 patients with recent ACS assessed the addition of different doses of dabigatran (50, 75, 110, and 150 mg BID) to DAPT that included clopidogrel.…”

Novel anticoagulants in the therapy of peripheral arterial and coronary artery disease

“…There is only dose findings study (phase II) for the oral direct thrombin inhibitor dabigatran etexilate (RE-DEEM) (31)(32)(33). In the RE-DEEM trial, with almost all patients receiving dual platelet inhibition, a dose-dependent increase in clinically relevant bleeding events was observed, with highest rates with the dabigatran etexilate 110 mg and 150 mg twice daily as currently used in atrial fibrillation.…”