Anticoagulant Cessation After Antiphospholipid Autoantibodies Loss in Thrombotic Antiphospholipid Syndrome

NCT07875153 · tracked via the Priya Life Science France tracker

Sponsor

Assistance Publique - Hôpitaux de Paris

Phase

Phase 3

Started

2026-12

Last updated

2026-10-15

Condition(s) studied

Antiphospholipid SyndromeThrombotic Antiphospholipid SyndromeThrombosis

Investigational drug(s) / intervention(s)

Vitamin K Antagonist - DrugAnticoagulant Therapy Discontinuation

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

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: 1. Adults ≥ 18 years old 2. Signed written consent form 3. Primary or secondary thrombotic APS according to 2023 ACR/EULAR classification criteria 4. aPL antibodies loss of LA, aCL, and aβ2GPI antibodies - defined as a normalised level (\< 99th percentile) - in at least two consecutive measurements with at least 12 months between each measurement including one negative measurement within the 3 months preceding inclusion 5. Long term (\>12 months) VKAs therapy Exclusion Criteria: 1. History of severe venous thrombosis. Severe venous thrombosis including massive pulmonary embolism; chronic thromboembolic pulmonary hypertension; hepatic, mesenteric, renal and/or cerebral venous thrombosis 2. History of arterial thrombosis 3. History of recurrent venous thrombosis while receiving VKAs 4. History of catastrophic antiphospholipid syndrome (CAPS) 5. Triple aPL positivity 6. Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 for each VKAs medicinal product 7. Malignant hypertension 8. Severe hepatic impairment 9. Active malignancy 10. Presence of a mechanical heart valve or any other medical condition requiring anticoagulation with a VKA 11. Pregnancy or breastfeeding 12. Subject deprived of freedom, subject under a legal protective measure 13. No affiliation to any health insurance system 14. Enrolment to another interventional study (clinical trial on medicinal product, medical device and interventional research involving human participants not concerning health product)

Primary outcome measure(s)

First Recurrent Of Thrombotic Event — Up to 48 months
Occurrence of a first recurrent thrombotic event during follow-up, in patients randomised to anticoagulation cessation compared to anticoagulation maintenance.

Trial sites (1)

Facility	City	Region	Status
AP-HP Hôpital Bichat - Claude Bernard	Paris	France

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07875153 on ClinicalTrials.gov ↗ ← All trials in France