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

Launched by MCMASTER UNIVERSITY · Dec 5, 2022

Keywords

ClinConnect Summary

This clinical trial is focused on understanding the effectiveness and safety of different blood-thinning treatments for patients with a condition called antiphospholipid syndrome (APS) who have experienced a clotting event in their arteries within the last year. The trial is collecting information about patients receiving various treatment options, including a combination of vitamin K antagonists (VKAs) and low-dose aspirin, VKAs alone, or other blood-thinning regimens. The goal is to determine which treatment works best at preventing further blood clots while keeping patients safe.

To be eligible for this trial, participants must be at least 18 years old, have a confirmed diagnosis of antiphospholipid syndrome, and have had a recent arterial clotting event. They should also be receiving one of the specified blood-thinning treatments. If you join the study, you can expect to be followed for two years, during which researchers will monitor your health and the effects of your treatment. This trial is currently recruiting participants, and it’s important to discuss with your doctor if this study might be right for you.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. 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.
• • 2. 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.
• • 3. Signed informed consent obtained (in jurisdictions where required).
• Exclusion Criteria:
• • 1. Inability to follow the patient due to geographical or other reasons.
• • 2. Patients with documented poor compliance.
• • 3. Bleeding risk that in the opinion of the treating physician makes combination antithrombotic therapy unsafe.
• • 4. Pregnancy or planned pregnancy.
• • 5. Venous thrombotic event diagnosed after the last arterial event.

Trial Officials