Study of Dual Therapy With Dabigatran and Ticagrelor Compared to Triple Therapy After Heart Procedure in Patients With Acute Coronary Syndrome and Non-valvular Atrial Fibrillation

What this Trial Is About

More than a quarter of patients undergoing diagnostic coronary angiography and percutaneous coronary intervention PCI for acute coronary syndrome ACS have non-valvular atrial fibrillation AF. Managing the balance between preventing blood clots and minimizing bleeding risk in these patients is challenging. Oral anticoagulants OAC reduce stroke and systemic embolism risk but do not prevent stent thrombosis, while dual antiplatelet therapy DAPT lowers ischemic events and stent thrombosis but is less effective against cardioembolic stroke. Current triple therapy combining OAC, aspirin, and clopidogrel carries a high risk of major bleeding, highlighting the need for safer effective treatments. This study is a randomized, open-label trial comparing two treatments in 1194 patients with non-valvular AF who had successful PCI within 120 hours after ACS. Participants are assigned to either dual therapy with dabigatran and reduced-dose ticagrelor or standard triple therapy with dabigatran, clopidogrel, and aspirin followed by dual therapy depending on bleeding and ischemic risks. Treatment continues for 12 months, with ticagrelor dosing adjusted over time and dabigatran dosing tailored based on age, kidney function, and bleeding risk. Participants will be monitored throughout the 12 months for bleeding events defined by international standards and for thromboembolic outcomes including heart attack, stroke, death, or unplanned revascularization. Researchers will assess the safety and efficacy of the dual therapy compared to the standard triple therapy. The trial includes detailed follow-up to evaluate bleeding risks and cardiovascular events, aiming to inform optimal treatment strategies for patients with AF and ACS after PCI.

Dual Antithrombotic Therapy With Dabigatran and Ticagrelor in Patients With ACS and Non-valvular AF Undergoing PCI