Dual Antithrombotic Therapy with Dabigatran and Ticagrelor in Patients with Acute Coronary Syndrome and Non-valvular Atrial Fibrillation Undergoing Percutaneous Coronary Intervention (ADONIS-PCI)
Medical Research Agency
Over 25% of patients referred for diagnostic coronary angiography and percutaneous coronary intervention (PCI) for acute coronary syndrome (ACS) suffer from non-valvular atrial fibrillation (AF). In this particular case, balancing the prevention of thrombosis with the risk of bleeding remains difficult. Oral anticoagulation (OAC) prevents stroke and systemic embolism but does not prevent in-stent thrombosis. Dual antiplatelet therapy (DAPT) reduces the incidence of recurrent ischemic events and stent thrombosis, but is less effective in reducing the incidence of cardio-embolic strokes associated with AF. It is common practice supported by the guidelines to combine all three drugs (OAC, aspirin, and clopidogrel) in triple therapy, but this approach remains the opinion of the experts. In addition, triple therapy is associated with a high annual risk (up to 25%) of major bleeding. Therefore, new therapeutic strategies are urgently needed to maintain efficacy while improving treatment safety in patients with AF and ACS undergoing PCI. We hypothesize that dual anticoagulation therapy, including a reduced dose of ticagrelor (study group, n = 1115), is not inferior in terms of bleeding risk and protection against ischemia compared to standard triple therapy (control group, n = 1115) in patients with AF and treated with PCI for ACS.
Duration of the study (project timeframe from 01/07/2020 to 06/30/2026):
Studied population. The target population for the study is male and female patients ≥18 years of age with non-valvular AF who underwent successful PCI for ACS. AF can be paroxysmal, persistent, or permanent, but cannot be secondary to a reversible disease such as myocardial infarction, pulmonary embolism, recent surgery, pericarditis, or thyrotoxicosis. ACS can be ST segment elevation myocardial infarction (STEMI), non-STEMI myocardial infarction (NSTEMI), or unstable angina (UA).