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

More than 25% of patients referred for diagnostic coronary angiography and percutaneous coronary intervention (PCI) due to acute coronary syndrome (ACS) suffer from non-valvular atrial fibrillation (AF). In this particular setting, balancing between the prevention of thrombosis and the risk of bleeding remains challenging. Oral anticoagulation (OAC) prevents stroke and systemic embolism, but has not been shown to prevent stent thrombosis (ST). Dual antiplatelet therapy (DAPT) reduces the incidence of recurrent ischemic events and ST, but is less effective in reducing the incidence of cardioembolic stroke associated with AF. A common guideline-supported practice is to combine three drugs (OAC, aspirin and clopidogrel) in a triple therapy, which is associated with high annual risk (up to 25%) of major bleeding. Thus, new therapeutic strategies are urgently needed to maintain the efficacy while improving the safety of treatment in patients with AF and ACS undergoing PCI. This is a prospective, randomized, open-label, blinded-endpoint, non-inferiority trial. 1194 patients with non-valvular AF that had undergone successful PCI due to an ACS within the previous 120 hours will be randomized in 1:1 ratio to receive one of the two treatments: dual therapy with dabigatran (150 mg twice daily or 110 mg twice daily) and ticagrelor (90 mg twice daily for 1 month, followed by 60 mg twice daily up to 12 months), or standard therapy according to current guidelines triple therapy with dabigatran (150 mg b.i.d. or 110 mg b.i.d.) plus clopidogrel (75 mg o.d.) plus aspirin (75 mg o.d.) followed by double therapy depending on the bleeding and ischaemic risk. Study treatment will be continued for 12 months. The primary study end-point is the first major or clinically relevant non-major bleeding event (per ISTH), in a time-to-event analysis. The main secondary end-point is a composite efficacy end-point of thromboembolic events (myocardial infarction, stroke, or systemic embolism), death, or unplanned revascularization (PCI or coronary artery bypass grafting) at 12 months. We expect that dual antithrombotic therapy including reduced dose ticagrelor and dabigatran is at least non-inferior regarding bleeding risk and ischaemic protection, compared to the standard triple therapy in patients with AF and after ACS, treated with PCI.

NCT Number	NCT04695106
Lead Sponsor	Medical University of Gdansk Collaborators: Medical University of Warsaw, Nicolaus Copernicus University, National Institute of Cardiology, Warsaw, Poland, Military Institute od Medicine National Research Institute, Bielanski Hospital, Medical University of Silesia, Poznan University of Medical Sciences, University of Opole, Poland, Medical University of Łódź, Voivodeship Hospital, Kielce, Poland, Voivode Specialist Hospital in Olsztyn, Poland, Medical University of Lublin, Pomeranian Medical University Szczecin, Central Clinical Hospital of the Ministry of Internal Affairs and Administration, Warsaw, Poland, American Heart of Poland, University of Warmia and Mazury in Olsztyn
Conditions	Atrial Fibrillation, Antithrombotic Therapy, Acute Coronary Syndrome, Percutaneous Coronary Interventions
Enrollment	1,194 participants
Start Date	2021-10-25
Primary Completion	2026-07-11 (estimated)
Study Completion	2026-08-31 (estimated)
Updated on ClinicalTrials.gov	2026-06-16