Actively Recruiting
CLOT-LESS - CLOsure Tailored: LEss Antithrombotic Strategy After LAAC for Stroke Prevention
Led by National Medical Research Center for Therapy and Preventive Medicine · Updated on 2026-05-08
464
Participants Needed
1
Research Sites
313 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a prospective, non-randomized, observational cohort study conducted at the FSBI "NMRC TPM" of the Ministry of Healthcare of the Russian Federation. Left atrial appendage closure (LAAC) has been shown to be non-inferior to oral anticoagulation for preventing cardioembolic events in patients with atrial fibrillation. However, the optimal post-procedural antithrombotic regimen following LAAC remains unclear, with no consensus on evidence-based therapy. Given current trends in cardiology favoring reduced-intensity antithrombotic strategies, this study aims to contribute to the evidence base by evaluating whether LAAC followed by reduced-dose apixaban (2.5 mg BID) for 3 months with subsequent complete withdrawal of antithrombotic therapy is superior to long-term standard-dose DOAC therapy in patients with non-valvular atrial fibrillation.
CONDITIONS
Official Title
CLOT-LESS - CLOsure Tailored: LEss Antithrombotic Strategy After LAAC for Stroke Prevention
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Documented nonvalvular atrial fibrillation lasting at least 30 seconds on ECG within the past 12 months
- CHA2DS2-VASc score of 3 or more for women and 2 or more for men
- Signed informed consent to participate in the study
You will not qualify if you...
- Need for anticoagulation for reasons other than atrial fibrillation at enrollment or during the study (e.g., mechanical valve, recent pulmonary embolism needing >3 months anticoagulation)
- Unable to tolerate at least 3 months of apixaban therapy (for LAAC group)
- Need for antiplatelet or P2Y12 inhibitor therapy at enrollment or planned during the study
- Presence of mechanical prosthetic heart valves or moderate to severe mitral stenosis
- Active deep vein thrombosis requiring anticoagulation
- Blood clotting disorders, rheumatic heart disease, or recurrent deep vein thrombosis
- Left ventricular ejection fraction below 30%
- Severe kidney disease (glomerular filtration rate under 30 ml/min) or dialysis
- Severe liver failure including cirrhosis and Child-Pugh Class C or D
- New York Heart Association class IV heart failure
- Heart attack within 30 days before LAAC
- Stroke within 30 days before LAAC
- Intracardiac blood clots before LAAC
- Major bleeding (type 3 or higher) within 30 days before LAAC or randomization
- Amyloid cardiomyopathy
- Platelet count below 100,000 x 10^9/l
- Participation in other studies except observational ones without treatment
- Pregnancy, breastfeeding, or planning pregnancy during the study
- Unsuccessful or interrupted LAAC procedure
- Peridevice leak of 3 mm or more
- Allergies or contraindications to study treatments
- Planned surgery within 30 days before or 90 days after LAAC, except minor procedures not requiring stopping antithrombotic therapy
- Heart tumor, active infection, or signs of tamponade
- Life expectancy less than 12 months
AI-Screening
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Trial Site Locations
Total: 1 location
1
Federal State Budgetary Institution National Medical Research Center for Therapy and Preventive Medicine of the Ministry of Healthсare of the Russian Federation
Moscow, Russia, 101990
Actively Recruiting
Research Team
T
Timofey Brontveyn, Medical doctor
CONTACT
K
Karapet Davtyan, Professor
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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