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Could a 3-Month Low-Dose blood thinner replace lifelong pills after heart procedure?

NCT ID NCT07575867

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at whether people with atrial fibrillation can safely stop taking long-term blood thinners after a procedure that closes off a part of the heart called the left atrial appendage. Participants will get a reduced dose of the blood thinner apixaban for just 3 months after the procedure, then stop all blood thinners. The goal is to see if this approach is better than staying on standard-dose blood thinners forever, by comparing rates of bleeding, stroke, and other complications.

What this could mean

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

Active substance
Apixaban (reduced dose) and left atrial appendage closure device (Watchman FLX or Amplatzer Amulet)
What this could lead to
If successful, this could offer a way for people with atrial fibrillation to stop taking lifelong blood thinners after a heart procedure, reducing bleeding risk while still preventing strokes.
What could go wrong
This is an observational study, not a randomized trial, so results may be less reliable. The reduced-dose apixaban is only given for 3 months, and there is a risk of stroke or device complications if blood thinners are stopped too soon.

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.

Participants

About 464 people

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

Expected to start

Apr 2026

An estimate. Start dates often move.

Expected to finish

Apr 2032

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

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

Who is studied

The study population comprises adults with documented non-valvular atrial fibrillation who require stroke prevention therapy. Two distinct cohorts will be enrolled: Cohort 1 (LAAC group): Patients with non-valvular atrial fibrillation and elevated thromboembolic risk who have relative or absolute contraindications to long-term oral anticoagulation, history of bleeding complications on anticoagulation, or patient preference for a non-pharmacological stroke prevention strategy. These patients will undergo percutaneous left atrial appendage closure. Cohort 2 (Control group): Patients with non-valvular atrial fibrillation and elevated thromboembolic risk who are appropriate candidates for and willing to continue long-term standard-dose direct oral anticoagulant therapy. Both cohorts will be recruited from the same institution during the same time period to minimize selection bias related to temporal trends in clinical practice.

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; * Documented nonvalvular AF (≥30 seconds on ECG within previous 12 months); * CHA2DS2-VASc score ≥3 for women and ≥2 for men; * Signed informed consent to participate in the study; Exclusion Criteria: * Active indication for anticoagulation OTHER than atrial fibrillation at the time of enrollment and/or the predicted/unpredicted occurrence of such indications during the entire study period (e.g., mechanical valve, acute VTE, recent PE requiring \>3 months anticoagulation); * Inability to tolerate at least 3 months of apixaban therapy (for LAAC arm); * Indications for antiplatelet therapy or therapy with P2Y12 inhibitors at the time of inclusion and/or the predicted/unpredicted occurrence of such indications during the entire study period; * The presence of mechanical prosthetic heart valves, mitral stenosis of severe or moderate degree; * Active DVT requiring anticoagulation; * Congenital or acquired haemostasis disorders, rheumatic heart disease or recurrent deep vein thrombosis; * Left ventricular ejection fraction (LVEF) \< 30%; * Glomerular filtration rate (GFR) \< 30 ml/min (stage IV or V chronic kidney disease) or dialysis patient; * Severe liver failure, including cirrhosis and Child-Pugh Class C/D; * NYHA class IV congestive heart failure; * The patient had a myocardial infarction - MI with or without ST segment elevation (STEMI, NSTEMI) with or without intervention, within 30 days before LAAC; * The patient had a stroke (of any cause, ischemic or hemorrhagic) within 30 days before LAAC; * Intracardiac thrombus before LAAC; * Major bleeding according to BARC criteria (type 3 and higher) within 30 days before LAAC or before randomization; * Amyloid cardiomyopathy; * Platelet count \< 100,000 x 109/l; * The patient participates in another study, with the exception of observational studies without therapeutic interventions; * Pregnant or breast-feeding patients, patients planning pregnancy during the study period; * The LAAC procedure was unsuccessful or interrupted for technical reasons; * PDL (peridevice leak) ≥ 3 mm; * Contraindications for one of the treatment regimens prescribed by the study protocol (including allergic reactions); * Planned cardiac or non-cardiac surgical procedure within 30 days before or 90 days after LAAC. Minor procedures not requiring discontinuation of antithrombotic therapy are permitted (e.g., cardioversion, catheter ablation, cataract surgery); * The patient has a heart tumor, active infection, signs of physiological tamponade; * The documented life expectancy of the patient is less than 12 months;

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

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

  1. The places running it

    1 site. 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

  • Federal State Budgetary Institution National Medical Research Center for Therapy and Preventive Medicine of the Ministry of Healthсare of the Russian Federation

    RECRUITING

    Moscow, 101990, Russia

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