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

• Primary safety endpoint - first major or clinically relevant non-major bleeding event, as defined by the ISTH

1. Study completion

   Aug 31, 2026

2. Primary completion

   Jul 11, 2026

3. Last registry update

   Jun 16, 2026

4. Started

   Oct 25, 2021

5. Registered

   Jan 5, 2021

• Dual antithrombotic therapy with dabigatran and ticagrelor in patients with acute coronary syndrome and non-valvular atrial fibrillation undergoing percutaneous coronary intervention (ADONIS-PCI): protocol for a randomized controlled pilot trial

  Cardiology journal