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

S

Stéphane Zuily

Status

Enrolling

Conditions

Anticoagulants Causing Adverse Effects in Therapeutic Use
Antiphospholipid Syndrome
Thrombosis

Treatments

Drug: Rivaroxaban

Study type

Observational

Funder types

Other

Identifiers

NCT04262492
2019-A01415-52

Details and patient eligibility

About

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

Enrollment

500 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

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

Trial contacts and locations

1

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Central trial contact

Virginie Dufrost, MD, MSc

Data sourced from clinicaltrials.gov

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