Clinical Research Directory

Anticoagulant Cessation After Antiphospholipid Autoantibodies Loss in Thrombotic Antiphospholipid Syndrome

This is an open-label, non-inferiority, randomized controlled trial with two parallel arms (experimental and control), following a PROBE (Prospective Randomized Open, Blinded Endpoint) design. The study evaluates whether anticoagulation cessation is non-inferior to anticoagulation maintenance regarding the risk of recurrent thrombosis after antiphospholipid antibodies (aPL) loss in patients with thrombotic antiphospholipid syndrome (APS). Currently, the cornerstone of APS treatment is long-term anticoagulation by vitamin K antagonists (VKAs), which expose patients to the risk of bleeding and have a negative impact on health-related quality of life due to the need for frequent International Normalized Ratio (INR) monitoring. No clinical trial in the existing literature has evaluated anticoagulant cessation after aPL loss. The primary endpoint is the first recurrent thrombotic event during follow-up.