Monotherapy With P2Y12 Inhibitors in Patients With Atrial fIbrillation Undergoing Supraflex Stent Implantation
Recruiting · NCT05955365 · Interventional (participants receive a specific treatment) · Lead sponsor: Insel Gruppe AG, University Hospital Bern
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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 can take part
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 is running
15 locations listed.
- UMC public - Amsterdam, Netherlands
- Universitätsspital Basel - Basel, Switzerland
- Inselspital, Bern University Hospital, Department of Cardiology - Bern, Switzerland
- Universitätsklinikum Frankfurt/Main - Frankfurt am Main, Germany
- Klinikum Friedrichshafen - Friedrichshafen, Germany
- Hôpitaux Universitaires de Genève - Geneva, Switzerland
- Hartcentrum Hasselt - Hasselt, Belgium
- Imperial College London - London, United Kingdom
- CHU Nîmes - Nîmes, France
- Uniwersytet Medyczny im. Karola Marcinkowskiego w Poznaniu - Poznan, Poland
- Hospital Universitario Marques de Valdecilla - Santander, Spain
- University Hospital Zürich - Zurich, Switzerland
- Cardiocentro Ticino Institute - Lugano, Canton Ticino, Switzerland
- Ospedale Ferrarotto - Catania, Catania CT, Italy
- IRCCS Humanitas - Milan, Rozzano, Italy