International Registry of Thrombotic APS Patients Treated With Direct Oral Anticoagulants

NCT04262492 | Recruiting DMC FDA Drug

• 1 other identifier: 2019-A01415-52
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Antiphospholipid Syndrome; Thrombosis; Anticoagulants Causing Adverse Effects in Therapeutic Use

Keywords

antiphospholipid syndrome; direct oral anticoagulants

Outcome Measures

Primary Outcomes (1)

• Rate of Recurrent Thrombosis

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

  6 months

Secondary Outcomes (3)

• Rate of Bleeding

  6 months

• Rate of Non-Criteria Manifestations

  6 months

• Adherence to treatment

  6 months

Interventions

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

Also known as: Dabigatran, Apixaban, Edoxaban

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Thrombotic APS patients according to revised Sapporo-Sydney criteria

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Stéphane Zuily: lead
• International Society on Thrombosis and Haemostasis: collaborator

Study Sites (1)

Stéphane Zuily

Nancy, 54500, France

RECRUITING

Related Publications (2)

• 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.

  PMID: 30103045 BACKGROUND

• 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.

  PMID: 28741234 BACKGROUND

Related Links

• ISTH SSC LA/aPL project
• OBSTINATE webpage

MeSH Terms

Conditions

Antiphospholipid Syndrome; Thrombosis

Interventions

Rivaroxaban; Dabigatran; apixaban; edoxaban

Condition Hierarchy (Ancestors)

Autoimmune Diseases; Immune System Diseases; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyridines; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Central Study Contacts

Virginie Dufrost, MD, MSc

CONTACT

+33383157828; v.dufrost@chru-nancy.Fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 6, 2020
• First Posted: February 10, 2020
• Study Start: October 21, 2020
• Primary Completion (Estimated): April 1, 2030
• Study Completion (Estimated): April 1, 2030
• Last Updated: February 9, 2024

Record last verified: 2024-02

Locations

FR (1)