Registry on Augmented Antithrombotic Treatment Regimens for Patients With Arterial Thrombotic APS
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Dual antiplatelet therapy, Combined antithrombotic therapy, Vitamin K antagonist standard intensity, Vitamin K antagonist high intensity.
- Who it may be relevant to
- Registry conditions: Antiphospholipid Syndrome, Arterial Thrombosis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Argentina, Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed description
The optimal antithrombotic management of patients with antiphospholipid syndrome and arterial thrombotic events is unclear. The guidelines provide several options, mostly with vitamin K antagonist with/without an antiplatelet agent. Dual antiplatelet therapy (DAPT) was in a meta-analysis potentially effective, but included studies were few and small.
The primary aim is to compare a vitamin K antagonist (VKA), i.e. warfarin, acenocoumarol, phenprocoumon etc, with international normalized ratio 2.0-3.0 plus low-dose aspirin (75-100 mg) with DAPT - typically low-dose aspirin plus clopidogrel (75 mg daily) but other combinations will be acceptable. The registry will also include patients treated with VKA alone at standard- or high-intensity, since this is recommended and will serve as reference groups in comparison with VKA + low-dose aspirin and versus DAPT. The outcomes are (efficacy) arterial or venous thromboembolism, vascular death or (safety) major bleeding.
A secondary objective is to analyze how the cardiovascular risk factors (hypertension, hyperlipidemia, obesity, smoking, diabetes, and heart failure), venous thrombotic risk factors (previous venous thromboembolism, cancer, immobility, chronic inflammatory disease) and anti-phospholipid profile contribute to recurrent arterial thrombosis.
Interventions
- Drug Dual antiplatelet therapy
Aspirin plus any of clopidogrel, ticagrelor or prasugrel - Drug Combined antithrombotic therapy
Combination of a vitamin K antagonist, such as warfarin, acenocoumarol, phenprocoumon, phenindione etc, with low-dose aspirin. - Drug Vitamin K antagonist standard intensity
vitamin K antagonist, such as warfarin, acenocoumarol, phenprocoumon, phenindione etc, with therapeutic range, international normalized ratio 2.0-3.0 - Drug Vitamin K antagonist high intensity
vitamin K antagonist, such as warfarin, acenocoumarol, phenprocoumon, phenindione etc, with therapeutic range, international normalized ratio 3.0-4.0
Primary outcome measures
- Number of Participants with thromboembolism verified by diagnostic imaging, electrocardiogram or troponin rise [Time frame: 2 years]
- Number of Participants with major hemorrhage fulfilling at least one of the International Society on Thrombosis and Haemostasis criteria [Time frame: 2 years]
Secondary outcome measures (3)
- Number of Participants with arterial thrombosis verified by diagnostic imaging [Time frame: 2 years]
- Number of Participants with venous thromboembolism verified by diagnostic imaging [Time frame: 2 years]
- Number of Participants with vascular death verified by diagnostic imaging, electrocardiogram or troponin rise [Time frame: 2 years]
Eligibility criteria
Inclusion criteria
- 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 criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Argentina · 2 centers
- Instituto de Investigaciones en Salud Pública, Universidad de Buenos Aires — Buenos Aires
- Clinica Universitaria Reina Fabiola — Córdoba
Canada · 1 center
- McMaster University — Hamilton
Identifiers
NCT: NCT05646394 · AATAAPS2021