Registry for Antithrombotic Treatments in Patients with Antiphospholipid Syndrome
Official title: Registry on Augmented Antithrombotic Treatment Regimens for Patients With Arterial Thrombotic APS
Run by McMaster University · NCT05646394 · Data updated 2026-11-12
This study is testing different blood-thinning treatments in people with antiphospholipid syndrome who had an artery problem in the last year to see which ones are safest and most effective.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 150 (estimated) |
| Sponsor | McMaster University Academic / other |
| Locations | 3 sites (Buenos Aires, Buenos Aires F.D. and 2 other locations) |
| Status | Recruiting |
| Started | July 1, 2022 |
| Main results expected | July 31, 2029 |
| Study ends | December 31, 2029 |
| Registry record updated | December 9, 2025 |
| Trial ID | NCT05646394 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adults aged 18 and older with confirmed antiphospholipid syndrome and a history of arterial thrombotic events.
✕Probably not a fit
Patients who are pregnant, have a high bleeding risk, or cannot comply with treatment protocols may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This registry aims to collect data on the efficacy and safety of various antithrombotic regimens in patients with antiphospholipid syndrome who have experienced an arterial event within the past year. Participants will be treated with different combinations of vitamin K antagonists and antiplatelet agents, with follow-up lasting two years. The study will compare outcomes such as arterial or venous thromboembolism and major bleeding among the treatment groups. Additionally, it will analyze how cardiovascular and venous thrombotic risk factors contribute to recurrent arterial thrombosis.
Why it matters
Potential benefit: If successful, this registry could help identify the most effective antithrombotic treatment strategies for patients with antiphospholipid syndrome, potentially reducing the risk of future thrombotic events.
How similar studies have gone: While there have been few studies on dual antiplatelet therapy in this context, the approach of comparing various antithrombotic regimens is novel and has not been extensively tested.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
-
Instituto de Investigaciones en Salud Pública, Universidad de Buenos Aires
Buenos Aires, Buenos Aires F.D., Argentina Recruiting -
Clinica Universitaria Reina Fabiola
Córdoba, Argentina Recruiting -
McMaster University
Hamilton, Ontario, Canada Recruiting
Study contacts
- Study coordinator: Sam Schulman, MD, PhD
- Email: schulms@mcmaster.ca
- Phone: +19055270271
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.