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NCT Number: NCT07570511

Point of Care Testing INR in Antiphospholipid Syndrome

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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Key information

Conditions

Antiphospholipid Syndrome Autoimmune Diseases Immune System Diseases Vitamine K Antagonist (VKA) Treatment

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHRU de Nancy

Vandœuvre-lès-Nancy, 54500, France

Location contact

Aurélie Emmerich

CONTACT

[email protected]

03 83 15 36 14 ext. +33

Denis Wahl, MD, PhD

SUB_INVESTIGATOR

Stéphane Zuily, MD, PhD

PRINCIPAL_INVESTIGATOR

Virginie Dufrost, MD

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Coaguchek

Device

Point of care testing INR using Coaguchek device

Primary outcomes

  1. Discrepancy between Coaguchek and venous INR

    Time frame: 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

Secondary outcomes

  1. Discrepancy between MicroLine and venous INR

    Time frame: At enrollment

    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

  2. Discrepancy between Coaguchek and MicroLine INR

    Time frame: At enrollment

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Stéphane ZUILY, MD, PhD

CONTACT

[email protected]

03 83 15 73 54 ext. +33

Sponsors and collaborators

Lead sponsor

Central Hospital, Nancy, France

Other

Registry information

Official study title

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

Acronym: POCTAS

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
May 6, 2026
Registry last updated
May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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