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

Antiphospholipid Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05646394
• Other study ID #: AATAAPS2021
• Status: Recruiting
• Start date: July 1, 2022
• Est. completion date: December 31, 2027

Study information

• Verified date: December 2022
• Source: McMaster University
• Contact: Sam Schulman, MD, PhD
• Phone: +19055270271
• Email: schulms[@]mcmaster.ca
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 31, 2027
• Est. primary completion date: July 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Antiphospholipid Syndrome
• Arterial Thrombosis
• Thrombosis

Intervention

Drug:
• Dual antiplatelet therapy
Aspirin plus any of clopidogrel, ticagrelor or prasugrel
• Combined antithrombotic therapy
Combination of a vitamin K antagonist, such as warfarin, acenocoumarol, phenprocoumon, phenindione etc, with low-dose aspirin.
• 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
• 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

Locations

Country	Name	City	State
Argentina	Instituto de Investigaciones en Salud Pública, Universidad de Buenos Aires	Buenos Aires	Ciudad Autónoma De Buenos Aires
Argentina	Clinica Universitaria Reina Fabiola	Córdoba
Canada	McMaster University	Hamilton	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
McMaster University	International Society on Thrombosis and Haemostasis

Countries where clinical trial is conducted

Argentina,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with thromboembolism verified by diagnostic imaging, electrocardiogram or troponin rise	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.	2 years
Primary	Number of Participants with major hemorrhage fulfilling at least one of the International Society on Thrombosis and Haemostasis criteria	Major hemorrhage according to the International Society on Thrombosis and Haemostasis	2 years
Secondary	Number of Participants with arterial thrombosis verified by diagnostic imaging	stroke, myocardial infarction, peripheral arterial thrombosis or embolism	2 years
Secondary	Number of Participants with venous thromboembolism verified by diagnostic imaging	thrombosis in any deep vein or pulmonary embolism	2 years
Secondary	Number of Participants with vascular death verified by diagnostic imaging, electrocardiogram or troponin rise	Death due to arterial or venous thromboembolism	2 years

External Links

•   Case report form - DO NOT ENTER DATA WITHOUT OBTAINING CENTER NUMBER; links to study protocol, ethics approval; informed consent form