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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorNational Medical Research Center for Therapy and Preventive Medicine

About this trial

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 criteria

Qualifiers

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;

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • Left Atrial Appendage Closure
  • Apixaban 2.5 mg BID
  • Standard-dose DOAC

Treatment groups

464 Participants
are divided into 2 treatment groups