Explaining the Differences Between Capillary INR and Plasma INR in Patients With Antiphospholipid Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Discrepancy between Coaguchek and venous INR
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
Lupus Anticoagulant positive patients
Patients with isolated Lupus Anticoagulant positive test only
干预措施: Coaguchek (Device)
Triple positive patients
Patients with triple positivity of antiphospholipid tests
干预措施: Coaguchek (Device)
Other antiphospholipid profile patients
Patients with another aPL profile other than isolated LAC or triple positivity
干预措施: Coaguchek (Device)
No antiphospholipid
Patients with no antiphospholipid antibodies
干预措施: Coaguchek (Device)
结局指标
主要结局
Discrepancy between Coaguchek and venous INR
时间窗: 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
次要结局
- Discrepancy between MicroLine and venous INR(At enrollment)
- Discrepancy between Coaguchek and MicroLine INR(At enrollment)
