Registry on Augmented Antithrombotic Treatment Regimens for Patients With Arterial Thrombotic APS
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMcMaster University
About this trial
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
Qualifiers
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).
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Dual antiplatelet therapy
- Combined antithrombotic therapy
- Vitamin K antagonist standard intensity
- Vitamin K antagonist high intensity
Treatment groups
No treatment groups listed
Sponsors and collaborators
McMaster University
Lead sponsor
International Society on Thrombosis and Haemostasis
Collaborator
Source ClinicalTrials.gov