Could a 3-Month Low-Dose blood thinner replace lifelong pills after heart procedure?
NCT ID NCT07575867
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
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About 464 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Apr 2026
An estimate. Start dates often move.
- Expected to finish
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Apr 2032
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Federal State Budgetary Institution National Medical Research Center for Therapy and Preventive Medicine of the Ministry of Healthсare of the Russian Federation
RECRUITINGMoscow, 101990, Russia
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