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Anticoagulant Cessation After Antiphospholipid Autoantibodies Loss in Thrombotic Antiphospholipid Syndrome
Sponsor: Assistance Publique - Hôpitaux de Paris
Summary
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.
Official title: A Randomised Controlled Trial to Evaluate Anticoagulant Cessation After Antiphospholipid Autoantibodies Loss in Thrombotic Antiphospholipid Syndrome
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
234
Start Date
2026-12
Completion Date
2031-01
Last Updated
2026-10-15
Healthy Volunteers
No
Interventions
Vitamin K Antagonist - Drug
Continuation of vitamin K antagonist therapy (fluindione, warfarin, or acenocoumarol), administered orally and dosed to obtain an International Normalized Ratio (INR) between 2 and 3, for a minimum of 24 months (up to 48 months depending on time of enrollment)
Anticoagulant Therapy Discontinuation
Discontinuation of vitamin K antagonist therapy at the randomisation visit. No anticoagulant treatment is administered during follow-up unless a recurrent thrombotic event occurs
Locations (1)
AP-HP Hôpital Bichat - Claude Bernard
Paris, France