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One drug at a time: could a simpler blood thinner strategy cut bleeding risk after stents?

NCT ID NCT05955365

Disease control Sponsor: Insel Gruppe AG, University Hospital Bern Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests a new approach for people with atrial fibrillation who have just received a coronary stent. Instead of taking multiple blood thinners together for months, the experimental group takes only one antiplatelet drug for the first month, then switches to a single anticoagulant. The goal is to see if this simpler routine reduces bleeding complications while still preventing heart attacks, strokes, and stent blockages. About 3,000 participants will be compared to those receiving the standard combination therapy.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
P2Y12 inhibitor (antiplatelet drug) followed by a direct-acting oral anticoagulant (DOAC)
What this could lead to
If this works, it could offer a simpler, safer blood-thinning routine for people with atrial fibrillation who have just had a coronary stent, lowering their risk of serious bleeding without raising the chance of heart attack or stroke.
What could go wrong
This is a large Phase 4 trial, but the strategy is still experimental. It may not protect against stent clotting or stroke as well as the current triple-drug approach, and individual responses to the drugs can vary.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 3,010 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2023

Expected to finish

Jun 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

atrial fibrillation

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Atrial fibrillation (AF) Oral anticoagulation P2Y12 inhibitor Percutaneous coronary intervention (PCI)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    15 sites in 9 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • CHU Nîmes

    NOT_YET_RECRUITING

    Nîmes, 30029, France

  • Cardiocentro Ticino Institute

    RECRUITING

    Lugano, Canton Ticino, 6900, Switzerland

  • Hartcentrum Hasselt

    NOT_YET_RECRUITING

    Hasselt, 3500, Belgium

  • Hospital Universitario Marques de Valdecilla

    NOT_YET_RECRUITING

    Santander, 39008, Spain

  • Hôpitaux Universitaires de Genève

    RECRUITING

    Geneva, 1211, Switzerland

  • IRCCS Humanitas

    NOT_YET_RECRUITING

    Milan, Rozzano, 20089, Italy

  • Imperial College London

    NOT_YET_RECRUITING

    London, SW7 2AZ, United Kingdom

  • Inselspital, Bern University Hospital, Department of Cardiology

    RECRUITING

    Bern, 3010, Switzerland

  • Klinikum Friedrichshafen

    NOT_YET_RECRUITING

    Friedrichshafen, 88048, Germany

  • Ospedale Ferrarotto

    NOT_YET_RECRUITING

    Catania, Catania CT, 95124, Italy

  • UMC public

    NOT_YET_RECRUITING

    Amsterdam, 1081, Netherlands

  • University Hospital Zürich

    RECRUITING

    Zurich, 8091, Switzerland

  • Universitätsklinikum Frankfurt/Main

    NOT_YET_RECRUITING

    Frankfurt am Main, 60590, Germany

  • Universitätsspital Basel

    RECRUITING

    Basel, 4031, Switzerland

  • Uniwersytet Medyczny im. Karola Marcinkowskiego w Poznaniu

    NOT_YET_RECRUITING

    Poznan, 61-701, Poland

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