Status:
NOT_YET_RECRUITING
DOAC Versus VKA in Patients With Non-high-risk APS : Prospective Cohort Study
Lead Sponsor:
Central Hospital, Nancy, France
Conditions:
Antiphospholipid Syndrome (APS)
Cohort Study
Eligibility:
All Genders
18+ years
Brief Summary
Antiphospholipid syndrome (APS) is a thrombotic disease requiring prolonged anticoagulation. Direct oral anticoagulants (DOACs) are indicated as 1st-line therapy in venous thrombosis, compared with VK...
Detailed Description
prospective cohort of APS patient treated with VKA or DOACs (specially oral Xa treatment). APS patients will be non high risk patients (no triple positivity, any previous arterial or small vessels th...
Eligibility Criteria
Inclusion
- Persons who have received full information about the organization of the research and have given their oral consent to participate.
- Male or female 18 years of age or older;
- Carrier of venous thrombotic SAPL:
- Not favoured by a major or ≥ 2 minor favouring factors, if the patient doesn't present with obstetrical SAPL in accordance with the ACR/EULAR 2023 clinical classification criteria.
- Or favored by ≥ 2 minors, if the patient has obstetrical SAPL: severe preeclampsia \< 34 weeks or placental insufficiency
- Regardless of how long the disease has been present
- With persistent positivity of at least one biological criterion:
- Positivity of circulating lupus anticoagulant or IgG anticardiolipid or IgG anti-beta-2GPI
- And persistence of the same positive test ≥ 12 weeks apart
- And With maximum delay of positivity of the 1st antiphospholipid test of 3 years after the thrombotic event
- Current anticoagulant treatment, regardless of date of introduction
- rivaroxaban or apixaban
- or antivitamin K
- Patient affiliated to a social security system
Exclusion
- Venous thrombotic event motivating current anticoagulant treatment favoured by a major favouring factor:
- Active cancer
- Hospitalization with bed rest for at least 3 days in the 3 months preceding the event
- Major trauma with fractures or spinal cord injury in the month preceding the event
- Surgery with general/spinal/epidural anesthesia for \> 30 minutes in the 3 months preceding the event.
- In the absence of a history of pre-eclampsia or placental insufficiency: venous thrombotic event motivating current anticoagulant treatment favoured by 2 or more minor favouring factors:
- Systemic autoimmune disease or active inflammatory bowel disease
- Acute/severe infection
- Central venous catheter in the same vascular bed
- Hormone replacement therapy, estrogenic oral contraceptives, or hormone-stimulating therapy in progress
- Long-distance travel (≥ 8 hours)
- Obesity (BMI ≥ 30 kg/m²)
- Pregnancy or post-partum (6 weeks after delivery)
- Prolonged immobilization
- Surgery with general/spinal/epidural anesthesia for \< 30 minutes in the 3 months preceding the event
- Known triple antiphospholipid positivity
- Isolated IgM antiphospholipid positivity
- History of known arterial thrombosis
- History of known microcirculatory thrombosis
- Known SAPL-related cardiac valvular disease
- Persons referred to in articles L. 1121-5, L. 1121-7 and L1121-8 of the Public Health Code
- Persons deprived of their liberty by judicial or administrative decision, persons under psychiatric care under articles L. 3212-1 and L. 3213-1.
- Glomerular filtration rate \< 30ml/min.
- Weight \< 50kg
- History of thrombotic recurrence under well-administered anticoagulant therapy.
Key Trial Info
Start Date :
September 15 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 15 2031
Estimated Enrollment :
310 Patients enrolled
Trial Details
Trial ID
NCT06884384
Start Date
September 15 2025
End Date
September 15 2031
Last Update
June 13 2025
Active Locations (13)
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1
Central Hospital, Nancy, France
Vandœuvre-lès-Nancy, Grand Est, France, 54500
2
CHU d'Amiens
Amiens, France, 80054
3
CHU de Besançon
Besançon, France, 25030
4
CHU de Brest
Brest, France, 29200