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Recruiting

NCT Number: NCT04262492

International Registry of Thrombotic APS Patients Treated With Direct Oral Anticoagulants

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

Recruiting

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Key information

Conditions

Antiphospholipid Syndrome Anticoagulants Causing Adverse Effects in Therapeutic Use Autoimmune Diseases Cardiovascular Diseases Embolism and Thrombosis Immune System Diseases Thrombosis Vascular Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Stéphane Zuily

Nancy, 54500, France

Location status: Recruiting

Location contact

Denis Wahl, MD, PhD

SUB_INVESTIGATOR

Stéphane Zuily, MD, PhD

CONTACT

[email protected]

+33383157354

Stéphane Zuily, MD, PhD

SUB_INVESTIGATOR

Virginie Dufrost, MD, MSc

PRINCIPAL_INVESTIGATOR

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rivaroxaban

Drug

Rivaroxaban 10 mg or 15 mg or 20 mg OD Dabigatran 110 mg or 150 mg BID Apixaban 2.5 mg or 5 mg or 10 mg BID

Other names: Dabigatran, Apixaban, Edoxaban

Primary outcomes

  1. Rate of Recurrent Thrombosis

    Time frame: 6 months

    Rate of Recurrent Thrombosis either arterial, venous or microvascular confirmed by a relevant exam

Secondary outcomes

  1. Rate of Bleeding

    Time frame: 6 months

    Rate of Bleeding either severe or major or clinically relevant non-major bleeding according to ISTH classification

  2. Rate of Non-Criteria Manifestations

    Time frame: 6 months

    Rate of Non-Criteria Manifestations according to Sydney criteria

  3. Adherence to treatment

    Time frame: 6 months

    Rate of patients who have a good adherence to oral anticoagulants assessed by the Girerd questionnaire

Study contacts

Contact information is provided by the study sponsor or research team.

Virginie Dufrost, MD, MSc

CONTACT

[email protected]

+33383157828

Sponsors and collaborators

Lead sponsor

Stéphane Zuily

Other

Collaborators

  • International Society on Thrombosis and Haemostasis

Registry information

Official study title

OBServaToire INternational Des Patients AnTiphospholipidEs traités Par Anticoagulants Oraux Directs

Acronym: OBSTINATE

Important dates

Study start
2020
Primary completion
2030
Study completion
2031
First posted
Feb 10, 2020
Registry last updated
May 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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