Dual Antithrombotic Therapy With Dabigatran and Ticagrelor in Patients With ACS and Non-valvular AF Undergoing PCI
Status:
Recruiting
Trial end date:
2026-03-31
Target enrollment:
Participant gender:
Summary
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. 2230
patients with non-valvular AF that had undergone successful PCI due to an ACS within the
previous 72 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.
Phase:
Phase 4
Details
Lead Sponsor:
Medical University of Gdansk
Collaborators:
Bielanski Hospital Central Clinical Hospital of the Ministry of Internal Affairs and Administration, Warsaw, Poland Institute of Cardiology, Warsaw, Poland Medical University of Lublin Medical University of Łódź Medical University of Silesia Medical University of Warsaw Military Institute of Medicine, Poland Nicolaus Copernicus University Pomeranian Medical University Szczecin Poznan University of Medical Sciences University of Opole, Poland Voivode Specialist Hospital in Olsztyn, Poland Voivodeship Hospital, Kielce, Poland