Registry on Augmented Antithrombotic Treatment Regimens for Patients With Arterial Thrombotic APS

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Drug
Study Type: Observational
SUMMARY

The goal of this registry is to gather more information on the efficacy and safety of various antithrombotic regimens. The registry collects data on patients with antiphospholipid syndrome and an arterial event within the past 12 months, on treatment with either A) a VKA with therapeutic range, INR 2.0-3.0 plus low-dose aspirin (75-100 mg daily), B) a VKA alone with therapeutic range, INR 2.0-3.0, C) a VKA with therapeutic range, INR 3.0-4.0, or D) with a dual antiplatelet regimen. The follow-up is 2 years.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Patients of at least 18 years of age with confirmed antiphospholipid syndrome according to Sydney criteria and with first or recurrent arterial thrombotic manifestation, including those with asymptomatic brain infarcts on diagnostic imaging.

• Treatment with either A) a vitamin K antagonist (VKA) with therapeutic range, international normalized ratio (INR) 2.0-3.0 plus low-dose aspirin (75-100 mg daily), B) a VKA alone with therapeutic range, INR 2.0-3.0 or C) VKA with therapeutic range, INR 3.0-4.0, or D) with a dual antiplatelet regimen, if considered appropriate by the treating physician.

• Signed informed consent obtained (in jurisdictions where required).

Locations
Other Locations
Argentina
Instituto de Investigaciones en Salud Pública, Universidad de Buenos Aires
RECRUITING
Buenos Aires
Clinica Universitaria Reina Fabiola
RECRUITING
Córdoba
Canada
McMaster University
RECRUITING
Hamilton
Contact Information
Primary
Sam Schulman, MD, PhD
schulms@mcmaster.ca
+19055270271
Backup
Hannah Cohen, MD, FRCP
hannah.cohen@ucl.ac.uk
+442034477368
Time Frame
Start Date: 2022-07-01
Estimated Completion Date: 2029-12-31
Participants
Target number of participants: 150
Related Therapeutic Areas
Sponsors
Collaborators: International Society on Thrombosis and Haemostasis
Leads: McMaster University

This content was sourced from clinicaltrials.gov