International Registry of Thrombotic APS Patients Treated With Direct Oral Anticoagulants

NCT ID: NCT04262492

Last Updated: 2024-02-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-10-21

Study Completion Date

2030-04-30

Brief Summary

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

Detailed Description

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Conditions

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Antiphospholipid Syndrome Thrombosis Anticoagulants Causing Adverse Effects in Therapeutic Use

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Rivaroxaban

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

Intervention Type DRUG

Other Intervention Names

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Dabigatran Apixaban Edoxaban

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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International Society on Thrombosis and Haemostasis

UNKNOWN

Sponsor Role collaborator

Stéphane Zuily

OTHER

Sponsor Role lead

Responsible Party

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Stéphane Zuily

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Stéphane Zuily

Nancy, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Virginie Dufrost, MD, MSc

Role: CONTACT

+33383157828

Facility Contacts

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Stéphane Zuily, MD, PhD

Role: primary

+33383157354

References

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Dufrost V, Risse J, Reshetnyak T, Satybaldyeva M, Du Y, Yan XX, Salta S, Gerotziafas G, Jing ZC, Elalamy I, Wahl D, Zuily S. Increased risk of thrombosis in antiphospholipid syndrome patients treated with direct oral anticoagulants. Results from an international patient-level data meta-analysis. Autoimmun Rev. 2018 Oct;17(10):1011-1021. doi: 10.1016/j.autrev.2018.04.009. Epub 2018 Aug 11.

Reference Type BACKGROUND
PMID: 30103045 (View on PubMed)

Dufrost V, Risse J, Wahl D, Zuily S. Direct Oral Anticoagulants Use in Antiphospholipid Syndrome: Are These Drugs an Effective and Safe Alternative to Warfarin? A Systematic Review of the Literature: Response to Comment. Curr Rheumatol Rep. 2017 Aug;19(8):52. doi: 10.1007/s11926-017-0676-2. No abstract available.

Reference Type BACKGROUND
PMID: 28741234 (View on PubMed)

Related Links

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Other Identifiers

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2019-A01415-52

Identifier Type: -

Identifier Source: org_study_id

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