PHP: Platelet Hyperreactivity Project

Sponsor
Pierre Fontana (Other)
Overall Status
Completed
CT.gov ID
NCT00976196
Collaborator
(none)
110
1
12
9.2

Study Details

Study Description

Brief Summary

The PHP study aims to delineate gene products involved in high on-treatment platelet reactivity in aspirin-treated cardiovascular patients.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The PHP study aims to delineate gene products involved in high on-treatment platelet reactivity in aspirin-treated cardiovascular patients using a system biology approach that include proteomics analysis of selected platelet sub-fractions in patients displaying extreme phenotype.

    Main objective:
    • to characterize the proteome profile of platelet hyperreactivity in aspirin-treated cardiovascular patients
    Secondary objectives:
    • to characterize the platelet hyperreactivity phenotype in cardiovascular patients treated with aspirin

    • to determine genetic polymorphisms associated with platelet hyperreactivity

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    110 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Platelet Hyperreactivity Project: A System Biology Approach of High On-treatment Platelet Reactivity in Aspirin-treated Cardiovascular Patients
    Study Start Date :
    Jan 1, 2009
    Actual Primary Completion Date :
    Jan 1, 2010
    Actual Study Completion Date :
    Jan 1, 2010

    Outcome Measures

    Primary Outcome Measures

    1. proteome profile of platelet hyperreactivity [cross sectional]

      to characterize the proteome profile of platelet hyperreactivity in aspirin-treated cardiovascular patients

    Secondary Outcome Measures

    1. platelet hyperreactivity phenotype in cardiovascular patients treated with aspirin [cross sectional]

    Other Outcome Measures

    1. genetic polymorphisms associated with platelet hyperreactivity [cross sectional]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 99 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Documented symptomatic ischemic atherothrombotic disease treated by aspirin.
    Exclusion Criteria:
    • Known platelet disorder

    • Chronic treatment by antiplatelet drugs other than aspirin

    • Chronic anticoagulant treatment

    • Chronic non steroidal anti-inflammatory drug treatment

    • Active cancer

    • Treatment with serotonin reuptake inhibitors

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University Hospital Geneva Geneva Switzerland 1205

    Sponsors and Collaborators

    • Pierre Fontana

    Investigators

    • Principal Investigator: Pierre Fontana, MD, PhD, University of Geneva

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Pierre Fontana, PI, University Hospital, Geneva
    ClinicalTrials.gov Identifier:
    NCT00976196
    Other Study ID Numbers:
    • 08-104
    First Posted:
    Sep 14, 2009
    Last Update Posted:
    Dec 2, 2015
    Last Verified:
    Dec 1, 2015
    Keywords provided by Pierre Fontana, PI, University Hospital, Geneva

    Study Results

    No Results Posted as of Dec 2, 2015