Antiphospholipid Syndrome, Vitamine K Antagonist (VKA) Treatment
Conditions
Keywords
INR, vitamin K, Antiphospholipid
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.
Interventions
DEVICECoaguchek
Point of care testing INR using Coaguchek device
Sponsors
Central Hospital, Nancy, France
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Discrepancy between Coaguchek and venous INR | 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
| Measure | Time frame | Description |
|---|---|---|
| Discrepancy between MicroLine and venous INR | At enrollment | Percentage of patients per group with a fixed 20% discrepancy between a capillary INR measured on a MicroLine INR© device and a venous INR according to subgroups and variables |
| Discrepancy between Coaguchek and MicroLine INR | At enrollment | Percentage of patients per group with a fixed 20% discrepancy between a capillary INR measured on a Coagucheck© and MicroLine devices according to subgroups and variables |
Countries
France
Contacts
CONTACTStéphane ZUILY, MD, PhD
Outcome results
None listed