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

Status: Recruiting
Location: See all (15) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Belgium
Hartcentrum Hasselt
NOT_YET_RECRUITING
Hasselt
France
CHU Nîmes
NOT_YET_RECRUITING
Nîmes
Germany
Universitätsklinikum Frankfurt/Main
NOT_YET_RECRUITING
Frankfurt Am Main
Klinikum Friedrichshafen
NOT_YET_RECRUITING
Friedrichshafen
Italy
Ospedale Ferrarotto
NOT_YET_RECRUITING
Catania
IRCCS Humanitas
NOT_YET_RECRUITING
Milan
Netherlands
UMC public
NOT_YET_RECRUITING
Amsterdam
Poland
Uniwersytet Medyczny im. Karola Marcinkowskiego w Poznaniu
NOT_YET_RECRUITING
Poznan
Spain
Hospital Universitario Marques de Valdecilla
NOT_YET_RECRUITING
Santander
Switzerland
Universitätsspital Basel
RECRUITING
Basel
Inselspital, Bern University Hospital, Department of Cardiology
RECRUITING
Bern
Hôpitaux Universitaires de Genève
RECRUITING
Geneva
Cardiocentro Ticino Institute
RECRUITING
Lugano
University Hospital Zürich
RECRUITING
Zurich
United Kingdom
Imperial College London
NOT_YET_RECRUITING
London
Contact Information
Primary
Stephan Windecker, Prof.
Stephan.Windecker@insel.ch
+41 31 632 44 97
Backup
Marco Valgimigli, Prof
Marco.Valgimigli@eoc.ch
+41 91 805 31 11
Time Frame
Start Date: 2023-12-18
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 3010
Treatments
Experimental: Monotherapy strategy
Patients randomized to the monotherapy treatment arm receive any of the commercially available oral P2Y12 inhibitors (clopidogrel, prasugrel oder ticagrelor) and immediately discontinue aspirin and DOAC (or will not re-start DOAC after PCI if treatment was temporarily stopped before). After 1 month, the P2Y12 inhibitor will be stopped and treatment with a commercially available DOAC (at investigator's discretion and dosed according to the instructions for use in patients with atrial fibrillation) will be initiated for the duration of 11 months. After completion of the 12-month study regimen (study visit), the patient will receive antithrombotic therapy according to routine care.
Active_comparator: Standard of care strategy
Patients randomized to the standard of care, receive DOAC for at least 12 months. In addition, aspirin is administered for up to 1 month after PCI at investigator's discretion and one of the available P2Y12 inhibitors (clopidogrel, prasugrel oder ticagrelor at investigator's discretion) is administered for a minimum of 6 months and up to 12 months after PCI. After completion of the 12-month control arm regimen (study visit), the patients will be treated according to routine care.
Sponsors
Collaborators: Sahajanand Medical Technologies Limited
Leads: Insel Gruppe AG, University Hospital Bern

This content was sourced from clinicaltrials.gov

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