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

Recruiting now

Conditions studied: Antiphospholipid Syndrome, Arterial Thrombosis

In brief

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.

Key facts

Study ID

NCT05646394

Run by

McMaster University

People needed

150

Starts

2022-07-01

Expected to finish

2029-12-31

Last updated by the study team

2025-12-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• Inability to follow the patient due to geographical or other reasons.
• Patients with documented poor compliance.
• Bleeding risk that in the opinion of the treating physician makes combination antithrombotic therapy unsafe.
• Pregnancy or planned pregnancy.
• Venous thrombotic event diagnosed after the last arterial event.

Where it is running

• Instituto de Investigaciones en Salud Pública, Universidad de Buenos Aires — Buenos Aires, Buenos Aires F.D., Argentina (enrolling)
• Clinica Universitaria Reina Fabiola — Córdoba, Argentina (enrolling)
• McMaster University — Hamilton, Ontario, Canada (enrolling)

Full record on ClinicalTrials.gov

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