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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lupus Anticoagulant positive patients | Experimental | Patients with isolated Lupus Anticoagulant positive test only |
|
| Triple positive patients | Experimental | Patients with triple positivity of antiphospholipid tests |
|
| Other antiphospholipid profile patients | Experimental | Patients with another aPL profile other than isolated LAC or triple positivity |
|
| No antiphospholipid | Active Comparator | Patients with no antiphospholipid antibodies |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Coaguchek | Device | Point of care testing INR using Coaguchek device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Discrepancy between Coaguchek and venous INR | 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 | At enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| Discrepancy between MicroLine and venous INR | 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 | At enrollment |
| Discrepancy between Coaguchek and MicroLine INR |
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Inclusion Criteria:
Patients with APS treated with vitamin K antagonists (VKAs)
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Stéphane ZUILY, MD, PhD | Contact | 03 83 15 73 54 | +33 | stephane.zuily@univ-lorraine.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHRU de Nancy | Vandœuvre-lès-Nancy | 54500 | France |
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| Label | URL |
|---|---|
| ISTH subcommittee website | View source |
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| ID | Term |
|---|---|
| D016736 | Antiphospholipid Syndrome |
| ID | Term |
|---|---|
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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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 |
| At enrollment |