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

NCT05646394 | Recruiting

• 1 other identifier: AATAAPS2021
• Study Type: observational
• Target: 150
• Locations: 2 countries
• Sites: 3

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.

Conditions

Antiphospholipid Syndrome; Arterial Thrombosis

Keywords

anticoagulation; vitamin K antagonist; antiaggregant; stroke; myocardial infarction; hemorrhage

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (3)

• Number of Participants with arterial thrombosis verified by diagnostic imaging

  2 years

• Number of Participants with venous thromboembolism verified by diagnostic imaging

  2 years

• Number of Participants with vascular death verified by diagnostic imaging, electrocardiogram or troponin rise

  2 years

Interventions

Dual antiplatelet therapy DRUG

Aspirin plus any of clopidogrel, ticagrelor or prasugrel

Also known as: Aspirin, Plavix, Brilinta, Effient

Combined antithrombotic therapy DRUG

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

Also known as: Vitamin K antagonist plus aspirin, Vitamin K antagonist plus antiaggregant, Vitamin K antagonist plus antiplatelet agent

Vitamin K antagonist high intensity DRUG

vitamin K antagonist, such as warfarin, acenocoumarol, phenprocoumon, phenindione etc, with therapeutic range, international normalized ratio 3.0-4.0

Also known as: VKA

Vitamin K antagonist standard intensity DRUG

vitamin K antagonist, such as warfarin, acenocoumarol, phenprocoumon, phenindione etc, with therapeutic range, international normalized ratio 2.0-3.0

Also known as: VKA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The decision on the treatment regimen should have been made by the treating physician on clinical grounds and judgement, prior to informing the patients about the registry. The information should include that vitamin K antagonist is the recommended standard, either alone or in combination and, in case dual antiplatelet regimen is chosen, an explanation to the patient for what reasons it should be used or continued. Patients that have been started on either of the eligible regimens after the most recent arterial thromboembolic event and within the past 12 months can be approached and informed about the study. If the patient meets the inclusion criteria and does not have any of the exclusion criteria, the investigator or designated representative obtains consent for collection of data.

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• McMaster University: lead
• International Society on Thrombosis and Haemostasis: collaborator

Study Sites (3)

Instituto de Investigaciones en Salud Pública, Universidad de Buenos Aires

Buenos Aires, Buenos Aires F.D., C1113 AAJ, Argentina

RECRUITING

Clinica Universitaria Reina Fabiola

Córdoba, Argentina

RECRUITING

McMaster University

Hamilton, Ontario, L9H 7M1, Canada

RECRUITING

Related Links

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

MeSH Terms

Conditions

Antiphospholipid Syndrome; Stroke; Myocardial Infarction; Hemorrhage

Interventions

Aspirin; Clopidogrel; Ticagrelor; Prasugrel Hydrochloride; Platelet Aggregation Inhibitors

Condition Hierarchy (Ancestors)

Autoimmune Diseases; Immune System Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Myocardial Ischemia; Heart Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Adenosine; Purine Nucleosides; Purines; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides; Piperazines; Hematologic Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Cary Clark

  International Society on Thrombosis and Haemostasis

  STUDY DIRECTOR

Central Study Contacts

Sam Schulman, MD, PhD

CONTACT

+19055270271; schulms@mcmaster.ca

Hannah Cohen, MD, FRCP

CONTACT

+442034477368; hannah.cohen@ucl.ac.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2022
• First Posted: December 12, 2022
• Study Start: July 1, 2022
• Primary Completion (Estimated): July 31, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: December 9, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Study protocol and ICF are available now and for 10 years after the end of the study. IPD will be available after the primary data have been published and for 10 years
• Access Criteria: A research plan is required.

Locations

AR (2); CA (1)