AntiPhosphoLipid antibodies and point-of-care INR measurement with CoaguChek - VervOlg Studie

AntiPhosphoLipid antibodies and point-of-care INR measurement with CoaguChek - VervOlg Studie - APLIVOS

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON56632

Enrollment

Registered

2023-10-13

Start date

2024-05-06

Completion date

Unknown

Last updated

2026-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Antiphospholipid syndrome Antiphospholipid syndrome

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Age 18 years and older - Previously confirmed APS, diagnosed in accordance with the Sydney criteria - High titers of anti-B2-glycoprotein-I IgG at screening (titer > 99th percentile) - Lupus anticoagulant positive at screening - Receiving VKA during at least 3 months - At least one thromboembolic event in the past - Willing and be able to understand the study information and sign the informed consent form

Exclusion criteria

Exclusion criteria: Patients with only obstetric complications of antiphospholipid syndrome without thrombotic events

Design outcomes

Primary

Measure	Time frame
The main study parameter is the difference in INR values measured with the Coaguchek and Coagulometer.	—

Secondary

Measure	Time frame
Secondary parameter includes the determination of antiphospholipid antibodies: IgG / IgM directed against cardiolipin, β2-Glycoprotein I and prothrombin, and antiphospholipid antibodies that prolong the clotting time in vitro, known as lupus anticoagulant.	—

Countries

Netherlands

Contacts

Public ContactA.C.A. Marijnissen

Universitair Medisch Centrum Utrecht

a.c.a.marijnissen@umcutrecht.nl0887550459

Outcome results