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ONASSIST: Registry of Coronary Artery Ill Patients With Platelet Test Results

Sponsor
Action, France (Other)
Overall Status
Recruiting
CT.gov ID
NCT02762162
Collaborator
(none)
5,000
Enrollment
1
Location
360
Duration (Months)
13.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

ONASSIST is a registry of coronary ill patients who have had a functional test measuring anti-platelet effect and/or a genetic profile of response to anti-platelet drugs.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The Onassist Project is an assistance for cardiologists that establishes an individual risk of stent thrombosis for each patient based on:

    • a functional approach (evaluation of the antiplatelet effect of the antiplatelet regimen by multiple tests) and

    • a pharmacogenomic approach (genetic profile of response to antiplatelet agents) It provides advices for specific therapeutics after identification of adverse drug interactions, treatment compliance issues and true genetic, functional or mixed resistance.

    This individualized strategy allow to adjust the choice of the drugs and their optimal dosage considering the best benefit - risk ratio.

    Follow up are regularly made to identify markers of MACE (major adverse cardiac event) or bleeding.

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    5000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Online Assistance for Stent Thrombosis
    Study Start Date :
    Jan 1, 2007
    Anticipated Primary Completion Date :
    Jan 1, 2027
    Anticipated Study Completion Date :
    Jan 1, 2037

    Outcome Measures

    Primary Outcome Measures

    1. Bleeding [10 years]

      all bleeding according to the BARC (Bleeding Academic Research Consortium) definitions are registered during the follow up

    2. Myocardial Infarction [10 years]

    3. Death [10 years]

    4. Stroke [10 years]

    5. Urgent Revascularization [10 years]

    6. Resuscitated Cardiac Arrest [10 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • coronary disease

    • antiplatelets testing performed as part of usual care and / or gentic profile of antiplatelet response done

    Exclusion Criteria:
    • patient refusing to be part of the registry

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hopital Pitie Salpetriere Paris France 75013

    Sponsors and Collaborators

    • Action, France

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Action, France
    ClinicalTrials.gov Identifier:
    NCT02762162
    Other Study ID Numbers:
    • ONASSIST
    First Posted:
    May 4, 2016
    Last Update Posted:
    Jan 30, 2019
    Last Verified:
    Jan 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Keywords provided by Action, France
    antiplatelet
    stent thrombosis
    Additional relevant MeSH terms:
    Myocardial Infarction
    Acute Coronary Syndrome
    Infarction

    Study Results

    No Results Posted as of Jan 30, 2019