RECRUITINGPhase 4INTERVENTIONAL

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

About This Trial

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").

Who May Be Eligible (Plain English)

Who May Qualify: - 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 willing to sign a consent form Who Should NOT Join This Trial: - 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 ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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

Treatments Being Tested

DRUG

P2Y12 inhibitor

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

DRUG

Aspirin

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

DRUG

DOAC

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