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Trial record 5 of 9 for:    Recruiting, Enrolling by invitation Studies | Antiphospholipid Syndrome | France

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04262492
Recruitment Status : Recruiting
First Posted : February 10, 2020
Last Update Posted : November 12, 2020
Sponsor:
Collaborator:
International Society on Thrombosis and Haemostasis
Information provided by (Responsible Party):
Stéphane Zuily, Central Hospital, Nancy, France

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.

Condition or disease Intervention/treatment
Antiphospholipid Syndrome Thrombosis Anticoagulants Causing Adverse Effects in Therapeutic Use Drug: Rivaroxaban

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: OBServaToire INternational Des Patients AnTiphospholipidEs traités Par Anticoagulants Oraux Directs
Actual Study Start Date : October 21, 2020
Estimated Primary Completion Date : April 2025
Estimated Study Completion Date : April 2028



Intervention Details:
  • Drug: 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
    Other Names:
    • Dabigatran
    • Apixaban
    • Edoxaban


Primary Outcome Measures :
  1. Rate of Recurrent Thrombosis [ Time Frame: 6 months ]
    Rate of Recurrent Thrombosis either arterial, venous or microvascular confirmed by a relevant exam


Secondary Outcome Measures :
  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



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Thrombotic APS patients according to revised Sapporo-Sydney criteria
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04262492


Contacts
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Contact: Virginie Dufrost, MD, MSc +33383157828 v.dufrost@chru-nancy.Fr

Locations
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France
Stéphane Zuily Recruiting
Nancy, France, 54500
Contact: Stéphane Zuily, MD, PhD    +33383157354    s.zuily@chru-nancy.fr   
Principal Investigator: Virginie Dufrost, MD, MSc         
Sub-Investigator: Denis Wahl, MD, PhD         
Sub-Investigator: Stéphane Zuily, MD, PhD         
Sponsors and Collaborators
Stéphane Zuily
International Society on Thrombosis and Haemostasis
Additional Information:
Publications:
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Responsible Party: Stéphane Zuily, Professor, Central Hospital, Nancy, France
ClinicalTrials.gov Identifier: NCT04262492    
Other Study ID Numbers: 2019-A01415-52
First Posted: February 10, 2020    Key Record Dates
Last Update Posted: November 12, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Keywords provided by Stéphane Zuily, Central Hospital, Nancy, France:
antiphospholipid syndrome
direct oral anticoagulants
Additional relevant MeSH terms:
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Antiphospholipid Syndrome
Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Autoimmune Diseases
Immune System Diseases
Rivaroxaban
Apixaban
Edoxaban
Dabigatran
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants