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

NCT07575867 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 464

Last updated 2026-05-08

No results posted yet for this study

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.

Conditions

  • Atrial Fibrillation
  • Stroke Prevention in Patients With Atrial Fibrillation
  • Left Atrial Appendage Closure
  • Hemorrhage
  • Anticoagulants / Administration & Dosage
  • Reduced-dose Apixaban
  • Thromboembolism

Interventions

DEVICE

Left Atrial Appendage Closure

Percutaneous left atrial appendage closure using Watchman FLX (Boston Scientific) or Amplatzer Amulet (Abbott) devices

DRUG

Apixaban 2.5 mg BID

Reduced-dose apixaban 2.5 mg BID for 3 months post-LAAC, followed by complete withdrawal of antithrombotic therapy

DRUG

Standard-dose DOAC

Standard-dose DOAC therapy (e.g., apixaban 5 mg BID, rivaroxaban 20 mg daily, or other DOAC per physician discretion) continued for the duration of follow-up

Sponsors & Collaborators

  • National Medical Research Center for Therapy and Preventive Medicine

    lead OTHER_GOV

Principal Investigators

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

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-30
Primary Completion
2032-04-30
Completion
2032-04-30

Countries

  • Russia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07575867 on ClinicalTrials.gov