Using P2Y12 inhibitors alone for patients with atrial fibrillation getting stents

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the safety and efficacy of a P2Y12 inhibitor monotherapy regimen for one month, followed by long-term treatment with direct-acting oral anticoagulants (DOACs) in patients with atrial fibrillation undergoing percutaneous coronary intervention with Supraflex stent implantation. The study compares this approach to the current standard of care, which involves a combination of three antithrombotic medications initially, followed by dual therapy. The trial is a multi-center, randomized, open-label study involving 3010 patients and aims to reduce the risk of bleeding complications while preventing ischemic events. Participants will be followed for a period of 12 months to assess outcomes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age ≥18 years
* Atrial fibrillation or flutter with an indication for oral anticoagulation using direct-acting oral anticoagulants (DOACs) for ≥12 months
* Successful percutaneous coronary intervention in at least 1 lesion within the previous 7 days with no remaining lesions intended for treatment.
* Free from major adverse events post qualifying PCI, including new onset chest pain suspected to be of ischemic origin, acute or subacute stent thrombosis, new-onset neurological signs or symptoms.
* Written informed consent

Exclusion Criteria:

* Planned staged percutaneous intervention procedure (Patients can be enrolled after complete coronary revascularization with no remaining lesions intended for treatment. Patients who have or develop indication to percutaneous valve intervention can undergo treatment more than 30 days after qualifying PCI.)
* Cardioversion for treatment of atrial fibrillation within 1 month prior to inclusion or planned cardioversion
* AF ablation procedure within 2 months prior to inclusion or planned AF ablation procedure
* Prior mechanical valvular prosthesis implantation
* Deep vein thrombosis/pulmonary embolism, at least moderately severe mitral stenosis or other clinical conditions than atrial fibrillation requiring long-term oral anticoagulation
* Stroke within 1 month prior to randomization
* Hemodynamic instability (persistent systolic blood pressure below 90 mmHg, continuous infusions of catecholamines, clinical signs of hypoperfusion and/or use of percutaneous left ventricular assist devices)
* Uncontrolled severe hypertension with a systolic blood pressure (BP) ≥180 mmHg and/or diastolic BP ≥120 mmHg
* Severe renal impairment with estimated creatinine clearance (CrCL) \<15 mL/min or on dialysis
* Moderate or severe hepatic impairment (Child-Pugh Class B or C) or any hepatic disease associated with coagulopathy
* Any hypersensitivity or contraindications for direct oral anticoagulation or dual antiplatelet therapy with aspirin and a P2Y12 inhibitor
* Any of the following abnormal local laboratory results prior to randomization: platelet count \<50 x109/L or hemoglobin \<8 g/dL
* Known pregnancy or breast-feeding patients
* Life expectancy \<1 year due to other severe non-cardiac disease
* Planned surgery including coronary artery bypass grafting within the next 6 months

Where it's running

• Cardiocentro Ticino Institute
  Lugano, Canton Ticino, Switzerland Recruiting
• Universitätsspital Basel
  Basel, Switzerland Recruiting
• Inselspital, Bern University Hospital, Department of Cardiology
  Bern, Switzerland Recruiting
• Hôpitaux Universitaires de Genève
  Geneva, Switzerland Recruiting
• University Hospital Zürich
  Zurich, Switzerland Recruiting
• Hartcentrum Hasselt
  Hasselt, Belgium Not yet recruiting

Study contacts

• Principal investigator: Stephan Windecker, Prof — Bern University Hospital, Department of Cardiology
• Study coordinator: Stephan Windecker, Prof.
• Email: Stephan.Windecker@insel.ch
• Phone: +41 31 632 44 97

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.