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Not yet recruiting NCT07570511

Point of Care Testing INR in Antiphospholipid Syndrome

No phase Interventional Antiphospholipid Syndrome Vitamine K Antagonist (VKA) Treatment

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Coaguchek.
Who it may be relevant to
Registry conditions: Antiphospholipid Syndrome, Vitamine K Antagonist (VKA) Treatment. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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

  • Device Coaguchek
    Point of care testing INR using Coaguchek device

Primary outcome measures

  • Discrepancy between Coaguchek and venous INR [Time frame: At enrollment]
Secondary outcome measures (2)
  • Discrepancy between MicroLine and venous INR [Time frame: At enrollment]
  • Discrepancy between Coaguchek and MicroLine INR [Time frame: At enrollment]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Diagnostic

Study locations

France · 1 center
  • CHRU de Nancy — Vandœuvre-lès-Nancy

Identifiers

NCT: NCT07570511 · 2024-A01316-41

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗