DOAC Versus VKA in Patients With Non-high-risk APS : Prospective Cohort Study

Launched by CENTRAL HOSPITAL, NANCY, FRANCE · Mar 13, 2025

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness of two types of blood thinners, Direct Oral Anticoagulants (DOACs) and Vitamin K Antagonists (VKAs), in patients with Antiphospholipid Syndrome (APS) who are not considered high-risk for blood clots. APS is a condition that increases the risk of blood clots, and while VKAs have been the standard treatment, DOACs may be easier to use and have a lower risk of bleeding. The trial aims to compare how often blood clots occur in patients taking DOACs versus those taking VKAs, specifically focusing on patients who do not have many other risk factors for clots.

To participate in this study, you must be at least 18 years old, have been diagnosed with APS, and currently be on either DOACs (like rivaroxaban or apixaban) or VKAs. Participants will continue their usual blood thinner treatment throughout the study, and the trial will follow their health over time to see if there are any differences in the frequency of blood clots. If you're interested in learning more about this trial and whether you might qualify, it's important to discuss it with your healthcare provider.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• * 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.