MedDataX Logo

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

NCT ID: NCT05646394

Last Updated: 2022-12-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-07-01

Study Completion Date

2027-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Antiphospholipid Syndrome Arterial Thrombosis

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

anticoagulation vitamin K antagonist antiaggregant stroke myocardial infarction hemorrhage

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Dual antiplatelet therapy

Aspirin plus any of clopidogrel, ticagrelor or prasugrel

Intervention Type DRUG

Combined antithrombotic therapy

Combination of a vitamin K antagonist, such as warfarin, acenocoumarol, phenprocoumon, phenindione etc, with low-dose aspirin.

Intervention Type 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

Intervention Type 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

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Aspirin Plavix Brilinta Effient Vitamin K antagonist plus aspirin Vitamin K antagonist plus antiaggregant Vitamin K antagonist plus antiplatelet agent VKA VKA

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

International Society on Thrombosis and Haemostasis

UNKNOWN

Sponsor Role collaborator

McMaster University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Cary Clark

Role: STUDY_DIRECTOR

International Society on Thrombosis and Haemostasis

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Instituto de Investigaciones en Salud Pública, Universidad de Buenos Aires

Buenos Aires, Buenos Aires F.D., Argentina

Site Status RECRUITING

Clinica Universitaria Reina Fabiola

Córdoba, , Argentina

Site Status RECRUITING

McMaster University

Hamilton, Ontario, Canada

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Argentina Canada

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Sam Schulman, MD, PhD

Role: CONTACT

Phone: +19055270271

Email: [email protected]

Hannah Cohen, MD, FRCP

Role: CONTACT

Phone: +442034477368

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Patricia Casais, MD, PhD

Role: primary

Soledad Molnar, MD

Role: primary

Sam Schulman

Role: primary

Related Links

Access external resources that provide additional context or updates about the study.

https://redcap.isth.org/surveys/?s=9RC8EEDPX3

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

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

AATAAPS2021

Identifier Type: -

Identifier Source: org_study_id