Registry on Augmented Antithrombotic Treatment Regimens for Patients With Arterial Thrombotic APS
McMaster University
150 participants
Jul 1, 2022
OBSERVATIONAL
Conditions
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
Inclusion Criteria3
- 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).
Exclusion Criteria5
- Inability to follow the patient due to geographical or other reasons.
- Patients with documented poor compliance.
- Bleeding risk that in the opinion of the treating physician makes combination antithrombotic therapy unsafe.
- Pregnancy or planned pregnancy.
- Venous thrombotic event diagnosed after the last arterial event.
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Interventions
Aspirin plus any of clopidogrel, ticagrelor or prasugrel
Combination of a vitamin K antagonist, such as warfarin, acenocoumarol, phenprocoumon, phenindione etc, with low-dose aspirin.
vitamin K antagonist, such as warfarin, acenocoumarol, phenprocoumon, phenindione etc, with therapeutic range, international normalized ratio 2.0-3.0
vitamin K antagonist, such as warfarin, acenocoumarol, phenprocoumon, phenindione etc, with therapeutic range, international normalized ratio 3.0-4.0
Locations(3)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05646394