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Monotherapy With P2Y12 Inhibitors in Patients With Atrial fIbrillation Undergoing Supraflex Stent Implantation
Sponsor: Insel Gruppe AG, University Hospital Bern
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").
Official title: Monotherapy With a P2Y12 Inhibitor Followed by a Direct-acting Oral Anticoagulant in Patients With ATRial fIbrillation Undergoing suprafleX Cruz Coronary Stent Implantation
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
3010
Start Date
2023-12-18
Completion Date
2026-12-31
Last Updated
2024-10-17
Healthy Volunteers
No
Conditions
Interventions
P2Y12 inhibitor
The choice of P2Y12 inhibitor is left at investigator's discretion.
Aspirin
Aspirin is administered for up to 1 month after PCI at investigator's discretion
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