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Comparing finger-prick and vein blood clotting tests in antiphospholipid syndrome

Compares finger-prick and vein INR results in adults with antiphospholipid syndrome.

Key facts

Who runs it
Central Hospital, Nancy, France
Where
France1 site in 1 countryChoose a country to see its sites
Trial code
Registry title
Point of Care Testing INR in Antiphospholipid Syndrome
Status
Not yet recruiting
People taking part
150 people, planned
Started
1 Jun 2026
Expected to end
1 Dec 2028
Type of study
Interventional, 4 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Coaguchek
Record updated
6 May 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults taking vitamin K antagonists (VKAs), blood thinners. It compares finger-prick INR and blood-draw INR in people with antiphospholipid syndrome (APS) and in control patients without these antibodies.

Age
18 years and older
Sex
All sexes
Disease stage
People with APS of any antibody profile: lupus anticoagulant (LA) alone, triple positivity, or another profile. Control patients without APS antibodies can also join.
Earlier treatment
Must be treated with vitamin K antagonists (VKAs).
Biomarker or test result
Groups by antibody profile: isolated LA (no aCL or anti-β2GPI), LA plus aCL and anti-β2GPI (triple positivity), or other profile. Controls have no aCL or anti-β2GPI.

Main reasons for not taking part

  • People with APS who are not treated with VKAs
  • Women who could become pregnant and do not use effective birth control
  • Pregnant women, women giving birth, or breastfeeding women
  • Adults under legal protection such as guardianship
  • People not covered by a social security scheme

The registry criteria, word for word

Show all 9 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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)

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

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.

The 4 groups in the trial

  • Lupus Anticoagulant positive patientsTreatment being tested

    Patients with isolated Lupus Anticoagulant positive test only

    Treatment: Coaguchek

  • Triple positive patientsTreatment being tested

    Patients with triple positivity of antiphospholipid tests

    Treatment: Coaguchek

  • Other antiphospholipid profile patientsTreatment being tested

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

    Treatment: Coaguchek

  • No antiphospholipidExisting treatment, for comparison

    Patients with no antiphospholipid antibodies

    Treatment: Coaguchek

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

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Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Explaining the Differences Between Capillary INR and Plasma INR in Patients With Antiphospholipid Syndrome
Plain-language title
Comparing finger-prick and vein blood clotting tests in antiphospholipid syndromeGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 15 November 2026.
Record updated
6 May 2026