NCT05646394 Registry on Augmented Antithrombotic Treatment Regimens for Patients With Arterial Thrombotic APS
| NCT ID | NCT05646394 |
| Status | Recruiting |
| Phase | — |
| Sponsor | McMaster University |
| Condition | Antiphospholipid Syndrome |
| Study Type | OBSERVATIONAL |
| Enrollment | 150 participants |
| Start Date | 2022-07-01 |
| Primary Completion | 2029-07-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 150 participants in total. It began in 2022-07-01 with a primary completion date of 2029-07-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Cary Clark
STUDY DIRECTOR
International Society on Thrombosis and Haemostasis
Frequently Asked Questions
Who can join the NCT05646394 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Antiphospholipid Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05646394 currently recruiting?
Yes, NCT05646394 is actively recruiting participants. Contact the research team at schulms@mcmaster.ca for enrollment information.
Where is the NCT05646394 trial being conducted?
This trial is being conducted at Buenos Aires, Argentina, Córdoba, Argentina, Hamilton, Canada.
Who is sponsoring the NCT05646394 clinical trial?
NCT05646394 is sponsored by McMaster University. The principal investigator is Cary Clark at International Society on Thrombosis and Haemostasis. The trial plans to enroll 150 participants.