Monotherapy With P2Y12 Inhibitors in Patients With Atrial fIbrillation Undergoing Supraflex Stent Implantation
NCT ID: NCT05955365
Last Updated: 2024-10-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
3010 participants
INTERVENTIONAL
2023-12-18
2026-12-31
Brief Summary
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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").
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Detailed Description
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The optimal antithrombotic treatment following percutaneous coronary intervention (PCI) in patients with atrial fibrillation (AF) requiring long-term oral anticoagulation remains a matter of debate. In particular, the appropriate intensity and duration of antithrombotic strategies to prevent ischemic events, while mitigating the risk of bleeding complications in this high bleeding risk population during the early peri-procedural period (within 30 days) and thereafter (from 30 days to 1 year) following drug-eluting stent implantation remains unclear.
Aim:
The investigators aim to assess the safety and efficacy of a P2Y12 inhibitor monotherapy regimen for 1 month followed by DOAC monotherapy long-term versus current standard of care consisting of triple antithrombotic therapy for up to one month (aspirin, P2Y12 inhibitor and DOAC) followed by dual antithrombotic therapy (P2Y12 inhibitor and DOAC) for 6 to 12 months and DOAC monotherapy thereafter, in AF patients undergoing PCI indicated for treatment with a DOAC after sirolimus-eluting Supraflex Cruz stent implantation and followed for a period of 12 months.
Methodology:
This investigator-initiated, multi-center, randomized, open-label, blinded evaluation, international clinical trial in 3010 AF patients with indication for long-term oral anticoagulation who have undergone successful PCI with Supraflex Cruz sirolimus-eluting biodegradable polymer cobalt chromium stent implantation. The study will be conducted at approximately 150 sites across Europe and Brazil. Patients will be randomized to the antithrombotic monotherapy (experimental antithrombotic strategy) or the standard of care strategy (control group) in a 1:1 ratio. Randomization is stratified by site, acute coronary syndrome (ACS) within the previous 6 months and CHA2DS2-VASc score ≥4. Patients randomized to the antithrombotic monotherapy treatment receive any of the commercially available oral P2Y12 inhibitors (clopidogrel, ticagrelor, prasugrel) and immediately discontinue aspirin and DOAC. After 1 month, the P2Y12 inhibitor will be stopped and treatment with a commercially available DOAC will be initiated for the duration of 11 months. Patients randomized to the standard of care strategy will initiate triple therapy for up to 1 month followed by dual anti-thrombotic therapy (consisting of P2Y12 inhibitor for a minimum of 6 and up to 12 months plus DOAC for at least 12 months).
Potential significance:
This is the first study investigation the impact of a short course of P2Y12 inhibitor monotherapy up to 1 month, while omitting clopidogrel non-responders, and temporarily omitting OAC, after stent implantation followed by OAC monotherapy in AF patients undergoing PCI. This sequential monotherapy treatment strategy has solid rational and carries potential to balance bleeding against cardiac and cerebral ischemic risks.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
P2Y12 inhibitor
The choice of P2Y12 inhibitor is left at investigator's discretion.
DOAC
The choice of DOAC is left at investigator's discretion.
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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Sahajanand Medical Technologies Limited
INDUSTRY
Insel Gruppe AG, University Hospital Bern
OTHER
Responsible Party
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Principal Investigators
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Stephan Windecker, Prof
Role: PRINCIPAL_INVESTIGATOR
Bern University Hospital, Department of Cardiology
Marco Valgimigli, Prof
Role: PRINCIPAL_INVESTIGATOR
Cardiocentro Ticino Institute
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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MATRIX-2
Identifier Type: -
Identifier Source: org_study_id
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