Explaining the Differences Between Capillary INR and Plasma INR in Patients With Antiphospholipid Syndrome
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- Discrepancy between Coaguchek and venous INR
Study Overview
Brief Summary
Antiphospholipid syndrome (APS) is an autoimmune and prothrombotic disorder that can affect up to 10% of young people experiencing a thrombotic event. Its treatment relies on long-term anticoagulation with vitamin K antagonists (VKAs). Direct oral anticoagulants, which are simpler to use because they do not require regular blood monitoring, are contraindicated because they are associated with an increased risk of thrombotic recurrence in some patients with APS.
Patients with APS receive VKAs and must regularly have their Index Normalized Ratio (INR) measured via a cumbersome venous blood draw. Capillary INR measurement systems are already used in certain situations, such as in patients with mechanical heart valves. The use of these systems improves the quality of life of these patients and, above all, the stability of VKA therapy, thus preventing potentially serious hemorrhagic complications or thrombotic recurrences.
In antiphospholipid syndrome (APS), these systems are discouraged due to perceived differences between capillary and venous INR (the reference method). However, among the few studies on the subject, none demonstrated significant discrepancies between patients with APS and controls, and when such discrepancies were observed, the origin of this variability could not be determined. We hypothesize that the biological profile of antiphospholipid antibodies is responsible for the INR differences.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients with APS treated with vitamin K antagonists (VKAs)
- •Patients with an LA profile without aCL or anti-β2GPI (isolated LA)
- •Patients with an LA and aCL + anti-β2GPI profile (triple positivity)
- •Patients with another biological profile (other than isolated LA or triple positivity)
- •Control patients without aCL or anti-β2GPI treated with VKAs
- •Adult patients
- •Patients who have undergone a prior clinical examination appropriate for the research
- •Individuals who have received complete information on the organization of the research and have not objected to their participation and the use of their data
- •Patients covered by a social security scheme
Exclusion Criteria
- •Patients with antiphospholipid syndrome (APS) not treated with vitamin K antagonists (VKAs)
- •Women of childbearing age without effective contraception
- •Persons covered by Articles L. 1121-5, L. 1121-7, and L. 1121-8 of the French Public Health Code:
- •Pregnant, parturient, or breastfeeding women
- •Unemancipated minors
- •Adults under legal protection (guardianship, curatorship, or protective supervision)
Arms & Interventions
Lupus Anticoagulant positive patients
Patients with isolated Lupus Anticoagulant positive test only
Intervention: Coaguchek (Device)
Triple positive patients
Patients with triple positivity of antiphospholipid tests
Intervention: Coaguchek (Device)
Other antiphospholipid profile patients
Patients with another aPL profile other than isolated LAC or triple positivity
Intervention: Coaguchek (Device)
No antiphospholipid
Patients with no antiphospholipid antibodies
Intervention: Coaguchek (Device)
Outcomes
Primary Outcomes
Discrepancy between Coaguchek and venous INR
Time Frame: At enrollment
Percentage of patients per group with a fixed 20% discrepancy between a capillary INR measured on a Coagucheck© device and a venous INR according to subgroups and variables
Secondary Outcomes
- Discrepancy between MicroLine and venous INR(At enrollment)
- Discrepancy between Coaguchek and MicroLine INR(At enrollment)