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临床试验/NCT07570511
NCT07570511尚未招募不适用

Explaining the Differences Between Capillary INR and Plasma INR in Patients With Antiphospholipid Syndrome

Central Hospital, Nancy, France1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2026年6月1日最近更新:
适应症
干预措施

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

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

Experimental

Patients with isolated Lupus Anticoagulant positive test only

干预措施: Coaguchek (Device)

Triple positive patients

Experimental

Patients with triple positivity of antiphospholipid tests

干预措施: Coaguchek (Device)

Other antiphospholipid profile patients

Experimental

Patients with another aPL profile other than isolated LAC or triple positivity

干预措施: Coaguchek (Device)

No antiphospholipid

Active Comparator

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)

研究者

发起方
Central Hospital, Nancy, France
申办方类型
Other
责任方
Sponsor

研究点 (1)

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