NCT07570511

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
30mo left

Started Jun 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 30, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 6, 2026

Completed
26 days until next milestone

Study Start

First participant enrolled

June 1, 2026

Expected
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2028

6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Last Updated

May 6, 2026

Status Verified

April 1, 2026

Enrollment Period

2 years

First QC Date

April 30, 2026

Last Update Submit

April 30, 2026

Conditions

Antiphospholipid SyndromeVitamine K Antagonist (VKA) Treatment

Keywords

INRvitamin KAntiphospholipid

Outcome Measures

Primary Outcomes (1)

  • Discrepancy between Coaguchek and venous INR

    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

    At enrollment

Secondary Outcomes (2)

  • Discrepancy between MicroLine and venous INR

    At enrollment

  • Discrepancy between Coaguchek and MicroLine INR

    At enrollment

Study Arms (4)

Lupus Anticoagulant positive patients

EXPERIMENTAL

Patients with isolated Lupus Anticoagulant positive test only

Device: Coaguchek

Triple positive patients

EXPERIMENTAL

Patients with triple positivity of antiphospholipid tests

Device: Coaguchek

Other antiphospholipid profile patients

EXPERIMENTAL

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

Device: Coaguchek

No antiphospholipid

ACTIVE COMPARATOR

Patients with no antiphospholipid antibodies

Device: Coaguchek

Interventions

CoaguchekDEVICE

Point of care testing INR using Coaguchek device

Lupus Anticoagulant positive patientsNo antiphospholipidOther antiphospholipid profile patientsTriple positive patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHRU de Nancy

Vandœuvre-lès-Nancy, 54500, France

Location

Related Links

MeSH Terms

Conditions

Antiphospholipid Syndrome

Condition Hierarchy (Ancestors)

Autoimmune DiseasesImmune System Diseases

Central Study Contacts

Stéphane ZUILY, MD, PhD

CONTACT

03 83 15 73 54stephane.zuily@univ-lorraine.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 30, 2026

First Posted

May 6, 2026

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

June 1, 2028

Study Completion (Estimated)

December 1, 2028

Last Updated

May 6, 2026

Record last verified: 2026-04

Locations

FR(1)