Anticoagulant Cessation After Antiphospholipid Autoantibodies Loss in Thrombotic Antiphospholipid Syndrome

Study acronym: ADORA
StatusNot Yet Recruiting
PhasePhase 3
Started

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Record History

  1. Minor Study First Submitted
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.
Trial Details
NCT Number NCT07875153
Lead Sponsor Assistance Publique - Hôpitaux de Paris
Collaborators: Direction Générale de l'Offre de Soin (DGOS)
Conditions
(from sponsor)
Antiphospholipid Syndrome, Thrombotic Antiphospholipid Syndrome, Thrombosis
Related terms Antiphospholipid Syndrome, Thrombosis
Enrollment 234 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov