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

NCT05955365 · tracked via the Priya Life Science Poland tracker

Sponsor

Insel Gruppe AG, University Hospital Bern

Phase

Phase 4

Started

2023-12-18

Last updated

2026-05-08

Condition(s) studied

Percutaneous Coronary Intervention (PCI)Atrial Fibrillation (AF)Oral AnticoagulationP2Y12 Inhibitor

Investigational drug(s) / intervention(s)

P2Y12 inhibitorAspirin →DOAC →

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.

Study 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

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

The number of participants with a major adverse cardiac or cerebral events (MACCE), defined as the composite of death from any cause, myocardial infarction, stroke or non-central nervous system (non-CNS) systemic embolism — 12 months
The number of participants with a major or clinically relevant non-major bleeding (MCB), defined according to the International Society of Thrombosis and Haemostasis (ISTH) criteria — 12 months

Trial sites (15)

Facility	City	Region	Status
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	Not Yet Recruiting
IRCCS Humanitas	Milan	Rozzano	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	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

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05955365 on ClinicalTrials.gov ↗ ← All trials in Poland