RecruitingPhase 4NCT05955365

Monotherapy With P2Y12 Inhibitors in Patients With Atrial fIbrillation Undergoing Supraflex Stent Implantation

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


Sponsor

Insel Gruppe AG, University Hospital Bern

Enrollment

3,010 participants

Start Date

Dec 18, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

Patients with atrial fibrillation undergoing percutaneous coronary intervention with stent implantation require treatment with different antithrombotic drugs. Oral anticoagulants are prescribed to reduce the risk of stroke associated with atrial fibrillation. Antiplatelet substances are prescribed after stent implantation to reduce the risk of adverse cardiac events such as myocardial infarction or stent thrombosis. Treatment with antithrombotic medications can cause bleeding complications, particularly when these substances are combined. The currently recommended standard strategy consists of treatment with 3 antithrombotic medications for at least 1 week up to one month, followed by treatment with two of these medications for up to 6-12 months after stent implantation. Thereafter, patients usually receive long-term treatment with only one drug, an anticoagulant. In the monotherapy group of this study, the investigators will investigate a strategy where only one antithrombotic drug will be used at a time. During the first month after stent implantation, the investigators will prescribe an antiplatelet medication, followed by an oral anticoagulant as monotherapy. This strategy might be associated with fewer bleeding complications, while protecting adequately against thrombotic events. In this study the investigators would like to investigate whether treatment with a single antithrombotic drug ("monotherapy strategy") is associated with benefits compared to the currently recommended combination therapy of antithrombotic medications ("standard-of-care strategy").


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial tests whether patients with atrial fibrillation who receive a coronary stent can safely take just one anti-clotting pill (a P2Y12 inhibitor) instead of the usual combination of a blood thinner plus anti-clotting medication. **You may be eligible if...** - You are 18 years or older - You have atrial fibrillation or atrial flutter and are taking a direct oral anticoagulant (blood thinner) - You recently had a successful coronary stent procedure (within the past 7 days) - You have had no major complications after the stent procedure **You may NOT be eligible if...** - You have another stent procedure planned in the near future - You recently had your heart rhythm corrected (cardioversion) or an ablation procedure for atrial fibrillation - You have a mechanical heart valve - You have a blood clot in your legs or lungs, or another condition requiring blood thinners - You recently had a stroke - You are hemodynamically unstable (low blood pressure or in shock) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGP2Y12 inhibitor

The choice of P2Y12 inhibitor is left at investigator's discretion.

DRUGAspirin

Aspirin is administered for up to 1 month after PCI at investigator's discretion

DRUGDOAC

The choice of DOAC is left at investigator's discretion.


Locations(15)

Hartcentrum Hasselt

Hasselt, Belgium

CHU Nîmes

Nîmes, France

Universitätsklinikum Frankfurt/Main

Frankfurt am Main, Germany

Klinikum Friedrichshafen

Friedrichshafen, Germany

Ospedale Ferrarotto

Catania, Catania CT, Italy

IRCCS Humanitas

Milan, Rozzano, Italy

UMC public

Amsterdam, Netherlands

Uniwersytet Medyczny im. Karola Marcinkowskiego w Poznaniu

Poznan, Poland

Hospital Universitario Marques de Valdecilla

Santander, Spain

Cardiocentro Ticino Institute

Lugano, Canton Ticino, Switzerland

Universitätsspital Basel

Basel, Switzerland

Inselspital, Bern University Hospital, Department of Cardiology

Bern, Switzerland

Hôpitaux Universitaires de Genève

Geneva, Switzerland

University Hospital Zürich

Zurich, Switzerland

Imperial College London

London, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT05955365


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