Atrial Fibrillation Clinical Trials

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CLOT-LESS - CLOsure Tailored: LEss Antithrombotic Strategy After LAAC for Stroke Prevention

Status: Recruiting
Location: See location...
Intervention Type: Drug, Device
Study Type: Observational
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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;

Locations
Other Locations
Russian Federation
Federal State Budgetary Institution National Medical Research Center for Therapy and Preventive Medicine of the Ministry of Healthсare of the Russian Federation
RECRUITING
Moscow
Contact Information
Primary
Timofey Brontveyn, Medical doctor
tbrontveyn.md@gmail.com
+79150579995
Backup
Karapet Davtyan, Professor
kdavtyan@gnicpm.ru
+79037758779
Time Frame
Start Date: 2026-04
Estimated Completion Date: 2032-04
Participants
Target number of participants: 464
Treatments
LAAC with reduced-dose anticoagulation
Patients undergoing left atrial appendage closure (LAAC) with Watchman FLX or Amplatzer Amulet devices, followed by reduced-dose apixaban (2.5 mg BID) for 3 months with subsequent complete withdrawal of antithrombotic therapy
Standard-dose DOAC
Patients receiving long-term standard-dose direct oral anticoagulant (DOAC) therapy per current guidelines
Related Therapeutic Areas
Sponsors
Leads: National Medical Research Center for Therapy and Preventive Medicine

This content was sourced from clinicaltrials.gov