Using P2Y12 inhibitors alone for patients with atrial fibrillation getting stents

Monotherapy With a P2Y12 Inhibitor Followed by a Direct-acting Oral Anticoagulant in Patients With ATRial fIbrillation Undergoing suprafleX Cruz Coronary Stent Implantation

This study is testing if using just one type of blood thinner for a month, followed by a different one, is safer and just as effective for people with atrial fibrillation who are getting heart stents, compared to the usual combination of three blood thinners.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 3010 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Insel Gruppe AG, University Hospital Bern (Academic / other)
• Locations: 15 sites (Hasselt and 14 other locations)
• Trial ID: NCT05955365 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with atrial fibrillation requiring long-term oral anticoagulation who have recently undergone successful percutaneous coronary intervention.

Not a fit: Patients who have planned staged percutaneous interventions or recent cardioversion procedures may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could reduce the risk of bleeding complications for patients with atrial fibrillation undergoing stent implantation.

How similar studies have performed: Other studies have explored antithrombotic strategies in similar populations, but this specific monotherapy approach is relatively novel.

Eligibility criteria

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 this trial is running

Hasselt and 14 other locations

• Hartcentrum Hasselt — Hasselt, Belgium (Not_yet_recruiting)
• CHU Nîmes — Nîmes, France (Not_yet_recruiting)
• Universitätsklinikum Frankfurt/Main — Frankfurt am Main, Germany (Not_yet_recruiting)
• Klinikum Friedrichshafen — Friedrichshafen, Germany (Not_yet_recruiting)
• Ospedale Ferrarotto — Catania, Catania CT, Italy (Not_yet_recruiting)
• IRCCS Humanitas — Milan, Rozzano, Italy (Not_yet_recruiting)
• UMC public — Amsterdam, Netherlands (Not_yet_recruiting)
• Uniwersytet Medyczny im. Karola Marcinkowskiego w Poznaniu — Poznan, Poland (Not_yet_recruiting)
• Hospital Universitario Marques de Valdecilla — Santander, Spain (Not_yet_recruiting)
• 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)
• Imperial College London — London, United Kingdom (Not_yet_recruiting)

Study contacts

• Principal investigator: Stephan Windecker, Prof — Bern University Hospital, Department of Cardiology
• Study coordinator: Stephan Windecker, Prof.

Conditions Percutaneous Coronary Intervention; Atrial Fibrillation; Oral Anticoagulation; P2Y12 Inhibitor