Actively Recruiting

Age: 18Years +
All Genders
NCT05646394

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

Led by McMaster University · Updated on 2025-12-09

150

Participants Needed

3

Research Sites

391 weeks

Total Duration

On this page

Sponsors

M

McMaster University

Lead Sponsor

I

International Society on Thrombosis and Haemostasis

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients aged 18 years or older with confirmed antiphospholipid syndrome according to Sydney criteria
  • First or recurrent arterial thrombotic event, including asymptomatic brain infarcts
  • Receiving treatment with either vitamin K antagonist plus low-dose aspirin, vitamin K antagonist alone (INR 2.0-3.0), vitamin K antagonist alone (INR 3.0-4.0), or dual antiplatelet therapy
  • Signed informed consent obtained where required
Not Eligible

You will not qualify if you...

  • Unable to follow the patient due to geographic or other reasons
  • Documented poor compliance
  • Bleeding risk considered unsafe for combination antithrombotic therapy by treating physician
  • Pregnant or planning pregnancy
  • Venous thrombotic event diagnosed after last arterial event

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 3 locations

1

Instituto de Investigaciones en Salud Pública, Universidad de Buenos Aires

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

Actively Recruiting

2

Clinica Universitaria Reina Fabiola

Córdoba, Argentina

Actively Recruiting

3

McMaster University

Hamilton, Ontario, Canada, L9H 7M1

Actively Recruiting

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Research Team

S

Sam Schulman, MD, PhD

CONTACT

H

Hannah Cohen, MD, FRCP

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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