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

Antiphospholipid Syndrome | Arterial Thrombosis

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.

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Participation Requirements

  • Sex:

    ALL
  • Eligible Ages:

    18 and up

Participation 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.

Study Location

McMaster University
McMaster University
Hamilton, Ontario
Canada

Contact Study Team

Primary Contact

Sam Schulman

[email protected]
9059796437
Study Sponsored By
McMaster University
Participants Required
More Information
Study ID: NCT05646394