Antiphospholipid Syndrome, Arterial Thrombosis
Conditions
Keywords
anticoagulation, vitamin K antagonist, antiaggregant, stroke, myocardial infarction, hemorrhage
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.
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
DRUGCombined antithrombotic therapy
Combination of a vitamin K antagonist, such as warfarin, acenocoumarol, phenprocoumon, phenindione etc, with low-dose aspirin.
DRUGVitamin K antagonist standard intensity
vitamin K antagonist, such as warfarin, acenocoumarol, phenprocoumon, phenindione etc, with therapeutic range, international normalized ratio 2.0-3.0
DRUGVitamin K antagonist high intensity
vitamin K antagonist, such as warfarin, acenocoumarol, phenprocoumon, phenindione etc, with therapeutic range, international normalized ratio 3.0-4.0
DRUGDual antiplatelet therapy
Aspirin plus any of clopidogrel, ticagrelor or prasugrel
Sponsors
International Society on Thrombosis and Haemostasis
McMaster University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with thromboembolism verified by diagnostic imaging, electrocardiogram or troponin rise | 2 years | Composite of arterial thrombosis (stroke, myocardial infarction, peripheral arterial thrombosis or embolism), venous thromboembolism (thrombosis in any deep vein or pulmonary embolism), and vascular death. |
| Number of Participants with major hemorrhage fulfilling at least one of the International Society on Thrombosis and Haemostasis criteria | 2 years | Major hemorrhage according to the International Society on Thrombosis and Haemostasis |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with arterial thrombosis verified by diagnostic imaging | 2 years | stroke, myocardial infarction, peripheral arterial thrombosis or embolism |
| Number of Participants with venous thromboembolism verified by diagnostic imaging | 2 years | thrombosis in any deep vein or pulmonary embolism |
| Number of Participants with vascular death verified by diagnostic imaging, electrocardiogram or troponin rise | 2 years | Death due to arterial or venous thromboembolism |
Countries
Argentina, Canada
Contacts
Primary ContactSam Schulman, MD, PhD
Backup ContactHannah Cohen, MD, FRCP
Outcome results
None listed