Actively Recruiting
Monotherapy With P2Y12 Inhibitors in Patients With Atrial fIbrillation Undergoing Supraflex Stent Implantation
Led by Insel Gruppe AG, University Hospital Bern · Updated on 2026-05-08
3010
Participants Needed
15
Research Sites
236 weeks
Total Duration
On this page
Sponsors
I
Insel Gruppe AG, University Hospital Bern
Lead Sponsor
S
Sahajanand Medical Technologies Limited
Collaborating Sponsor
AI-Summary
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").
CONDITIONS
Official Title
Monotherapy With P2Y12 Inhibitors in Patients With Atrial fIbrillation Undergoing Supraflex Stent Implantation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Atrial fibrillation or flutter requiring direct oral anticoagulants for at least 12 months
- Successful percutaneous coronary intervention in at least one lesion within the previous 7 days with no remaining lesions for treatment
- No major adverse events after the qualifying PCI, including no new chest pain suspected to be ischemic or new neurological symptoms
- Provided written informed consent
You will not qualify if you...
- Planned staged percutaneous intervention procedure or planned percutaneous valve intervention within 30 days after PCI
- Cardioversion for atrial fibrillation within 1 month before enrollment or planned cardioversion
- Atrial fibrillation ablation procedure within 2 months before enrollment or planned ablation
- Prior mechanical heart valve implantation
- Deep vein thrombosis, pulmonary embolism, moderate or severe mitral stenosis, or other conditions requiring long-term oral anticoagulation besides atrial fibrillation
- Stroke within 1 month before randomization
- Hemodynamic instability or use of mechanical heart support devices
- Uncontrolled severe hypertension with systolic blood pressure ≥180 mmHg or diastolic blood pressure ≥120 mmHg
- Severe kidney impairment with creatinine clearance less than 15 mL/min or dialysis
- Moderate or severe liver impairment or liver disease with bleeding problems
- Allergy or contraindications to direct oral anticoagulants or dual antiplatelet therapy including aspirin and P2Y12 inhibitors
- Low platelet count below 50 x10^9/L or hemoglobin below 8 g/dL prior to randomization
- Known pregnancy or breastfeeding
- Life expectancy less than 1 year due to severe non-cardiac disease
- Planned surgery including coronary artery bypass grafting within the next 6 months
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 15 locations
1
Hartcentrum Hasselt
Hasselt, Belgium, 3500
Not Yet Recruiting
2
CHU Nîmes
Nîmes, France, 30029
Not Yet Recruiting
3
Universitätsklinikum Frankfurt/Main
Frankfurt am Main, Germany, 60590
Not Yet Recruiting
4
Klinikum Friedrichshafen
Friedrichshafen, Germany, 88048
Not Yet Recruiting
5
Ospedale Ferrarotto
Catania, Catania CT, Italy, 95124
Not Yet Recruiting
6
IRCCS Humanitas
Milan, Rozzano, Italy, 20089
Not Yet Recruiting
7
UMC public
Amsterdam, Netherlands, 1081
Not Yet Recruiting
8
Uniwersytet Medyczny im. Karola Marcinkowskiego w Poznaniu
Poznan, Poland, 61-701
Not Yet Recruiting
9
Hospital Universitario Marques de Valdecilla
Santander, Spain, 39008
Not Yet Recruiting
10
Cardiocentro Ticino Institute
Lugano, Canton Ticino, Switzerland, 6900
Actively Recruiting
11
Universitätsspital Basel
Basel, Switzerland, 4031
Actively Recruiting
12
Inselspital, Bern University Hospital, Department of Cardiology
Bern, Switzerland, 3010
Actively Recruiting
13
Hôpitaux Universitaires de Genève
Geneva, Switzerland, 1211
Actively Recruiting
14
University Hospital Zürich
Zurich, Switzerland, 8091
Actively Recruiting
15
Imperial College London
London, United Kingdom, SW7 2AZ
Not Yet Recruiting
Research Team
S
Stephan Windecker, Prof.
CONTACT
M
Marco Valgimigli, Prof
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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