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Taking peoplePhase 4

Single blood-thinning drug after heart stent placement in atrial fibrillation

Tests one blood-thinner at a time after stent placement in adults with atrial fibrillation.

Key facts

Who runs it
Insel Gruppe AG, University Hospital Bern
Where
Nîmes, FranceSee the siteAlso in 8 other countries, 14 sites
Trial code
Registry title
Monotherapy With P2Y12 Inhibitors in Patients With Atrial fIbrillation Undergoing Supraflex Stent Implantation
Status
Recruiting
Phase
Phase 4
People taking part
3,010 people, planned
Started
18 Dec 2023
Expected to end
30 Jun 2028
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • P2Y12 inhibitor
  • Aspirin
  • DOAC
Record updated
8 May 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with atrial fibrillation or flutter who recently had a successful coronary stent procedure and need long-term blood-thinning tablets (DOACs).

Age
18 years or older
Sex
Men and women
Disease stage
Atrial fibrillation or flutter needing a DOAC for at least 12 months; a successful stent procedure (PCI) in the last 7 days with no other lesions left to treat; no major problems such as chest pain, stent clot or new nerve symptoms since the procedure.
Earlier treatment
Successful percutaneous coronary intervention (stent) in at least 1 lesion within the previous 7 days.

Main reasons for not taking part

  • Another stent procedure is planned, or a heart bypass operation within 6 months
  • Mechanical heart valve, or another condition besides atrial fibrillation that needs long-term blood thinners
  • Stroke within 1 month, or unstable circulation
  • Severe kidney problems (CrCL <15 mL/min) or dialysis, or moderate to severe liver disease
  • Known pregnancy or breast-feeding

The registry criteria, word for word

Show all 20 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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
  • Stroke within 1 month prior to randomization
  • Planned surgery including coronary artery bypass grafting within the next 6 months
  • Deep vein thrombosis/pulmonary embolism, at least moderately severe mitral stenosis or other clinical conditions than atrial fibrillation requiring long-term oral anticoagulation
  • Uncontrolled severe hypertension with a systolic blood pressure (BP) ≥180 mmHg and/or diastolic BP ≥120 mmHg
  • 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
  • Life expectancy <1 year due to other severe non-cardiac disease
  • Severe renal impairment with estimated creatinine clearance (CrCL) <15 mL/min or on dialysis
  • Any of the following abnormal local laboratory results prior to randomization: platelet count <50 x109/L or hemoglobin <8 g/dL
  • 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.)
  • 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)
  • Known pregnancy or breast-feeding patients

Where in France

Also in 8 other countries, 14 sites

  • CHU NîmesNîmes, FranceContact: Guillaume Cayla, ProfNot yet recruiting

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

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").

The 2 groups in the trial

  • Monotherapy strategyTreatment being tested

    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.

    Treatment: P2Y12 inhibitor and DOAC

  • Standard of care strategyExisting treatment, for comparison

    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.

    Treatment: P2Y12 inhibitor, Aspirin, and DOAC

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
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
Plain-language title
Single blood-thinning drug after heart stent placement in atrial fibrillationGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
8 May 2026