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

Locations

1
Federal State Budgetary Institution National Medical Research Center for Therapy and Preventive Medicine of the Ministry of Healthсare of the Russian Federation101990, Moscow Russia

Sponsors and collaborators

National Medical Research Center for Therapy and Preventive Medicine

Lead sponsor