Laboratory and Clinical Data in Antiphospholipid Patients

Antiphospholipid Syndrome Clinical Trial

— APSregistry  

Official title:

Constitution d'Une Collection d'Echantillons Biologiques Associee a Une Base de Donnees de Patients Possedant Des Anticorps Antiphospholipides

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04308564
• Other study ID #: 2019-A02058-49
• Status: Recruiting
• Start date: April 12, 2021
• Est. completion date: April 1, 2031

Study information

• Verified date: December 2021
• Source: Central Hospital, Nancy, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

To constitute a registry of antiphospholipid antibodies positive-patients

Description:

An international web-based application, the REDCap (Research Electronic Data Capture), captures data on patient demographics, aPL-related clinical and laboratory characteristics, and medications. The inclusion criteria are: a) age between 18 and 60 years; and b) persistent (at least 12 weeks apart) aPL-positivity within 12 months prior to screening; positivity is defined as anticardiolipin antibodies (aCL) IgG/M/A (> 40 GPL/MPL/APL, medium-to-high titer, and/or greater than the 99th percentile), anti-β2-glycoprotein-I (aβ2GPI) IgG/M/A (> 40 units, medium-to-high titer), positive lupus anticoagulant (LA) test based on International Society on Thrombosis and Hemostasis and other current guidelines. Patients are followed every 12 ± 3 months with clinical data and blood collection. Blood drawn is done at inclusion and every year.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: April 1, 2031
• Est. primary completion date: April 1, 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• age between 18 and 60 years;

• persistent (at least 12 weeks apart) aPL-positivity within 12 months prior to screening

Exclusion Criteria:

• no inform consent

• impossible follow up

• pregnancy

Related Conditions & MeSH terms

• Antiphospholipid Syndrome

Intervention

Diagnostic Test:
• Blood test
Blood test for the identification of biomarkers

Locations

Country	Name	City	State
France	CHRU de Lille	Lille
France	CHRU de Nancy	Nancy

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Thrombosis	Rate of thrombosis	Up to 10 years
Secondary	Bleeding	Rate of bleeding	Up to 10 years