International Registry of Thrombotic APS Patients Treated With Direct Oral Anticoagulants (OBSTINATE)

May 7, 2026 updated by: Stéphane Zuily

OBServaToire INternational Des Patients AnTiphospholipidEs traités Par Anticoagulants Oraux Directs

This registry, currently being established will ensure consistency of data collection and provide safety information in non high-risk APS patients currently on DOACs.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Nancy, France, 54500
        • Recruiting
        • Stéphane Zuily
        • Contact:
        • Principal Investigator:
          • Virginie Dufrost, MD, MSc
        • Sub-Investigator:
          • Denis Wahl, MD, PhD
        • Sub-Investigator:
          • Stéphane Zuily, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Thrombotic APS patients according to revised Sapporo-Sydney criteria

Description

Inclusion Criteria:

  • Patient receiving a comprehensive information about the study, and not opposed to participate
  • Age ≥ 18 yo
  • Classification of definite APS according to revised Sapporo-Sydney criteria
  • Direct oral anticoagulant treatment prescribed during at least 6 months or with the possibility of follow-up of at least 6 months

Exclusion Criteria:

  • Incomplete revised Sapporo-Sydney criteria
  • No data regarding the recurrent thrombosis
  • Pregnant woman
  • Age < 18 yo

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of Recurrent Thrombosis
Time Frame: 6 months
Rate of Recurrent Thrombosis either arterial, venous or microvascular confirmed by a relevant exam
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of Bleeding
Time Frame: 6 months
Rate of Bleeding either severe or major or clinically relevant non-major bleeding according to ISTH classification
6 months
Rate of Non-Criteria Manifestations
Time Frame: 6 months
Rate of Non-Criteria Manifestations according to Sydney criteria
6 months
Adherence to treatment
Time Frame: 6 months
Rate of patients who have a good adherence to oral anticoagulants assessed by the Girerd questionnaire
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stéphane Zuily

Collaborators

International Society on Thrombosis and Haemostasis

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 21, 2020

Primary Completion (Estimated)

April 21, 2030

Study Completion (Estimated)

April 21, 2031

Study Registration Dates

First Submitted

February 6, 2020

First Submitted That Met QC Criteria

February 7, 2020

First Posted (Actual)

February 10, 2020

Study Record Updates

Last Update Posted (Actual)

May 8, 2026

Last Update Submitted That Met QC Criteria

May 7, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019-A01415-52

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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