NCT05646394Recruiting
Registry on Augmented Antithrombotic Treatment Regimens for Patients With Arterial Thrombotic APS
Source: ClinicalTrials.gov · Last updated 9 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 150 (estimated)
- First submitted
- 5 Dec 2022
- Start date
- 1 Jul 2022
- Primary completion date
- 31 Jul 2029
- Lead sponsor
- McMaster University
- Diseases
- Coronary artery disease, Stroke
- NCT number
- NCT05646394
What you commit to
- Study type: Observational
- Planned participants: 150
- From 1 Jul 2022 to the primary completion date, 31 Jul 2029
- 3 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Bleeding risk that in the opinion of the treating physician makes combination antithrombotic therapy unsafe.
Other
- Inability to follow the patient due to geographical or other reasons.
- Patients with documented poor compliance.
- Pregnancy or planned pregnancy.
- Venous thrombotic event diagnosed after the last arterial event.
Who the study is looking for
- 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).
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Instituto de Investigaciones en Salud Pública, Universidad de Buenos Aires Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Recruiting |
| Clínica Universitaria Reina Fabiola Coordinator of this site? Confirm its status | Córdoba | Argentina | Recruiting |
| McMaster University Coordinator of this site? Confirm its status | Hamilton | Canada | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.