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Thromboelastography As A Tool for Possible Clopidogrel Resistance in The Patients Treated With Primary PCI for STEMI

Sponsor
Assaf-Harofeh Medical Center (Other)
Overall Status
Unknown status
CT.gov ID
NCT00517478
Collaborator
(none)
50
Enrollment
1
Location
6
Duration (Months)
8.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Determine usefulness of thromboelastography (TEG) as a valuable tool in ex-vivo assessing platelet response to aspirin and clopidogrel (dual) treatment and on-treatment platelet reactivity during acute ST segment elevation myocardial infarction (STEMI) in an acute phase during primary PCI (PPCI) and also during recovery been on maintenance medical therapy and to determine the correlation between platelet response to clopidogrel treatment and the outcome of patients.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Blood Sample

Detailed Description

Dual anti-aggregant therapy is recommended standard of therapy applicable to all patient groups undergoing PPCI. The aspirin-clopidogrel regiment is signed to every patient without assessing therapeutic effect. In face of growing evidence of platelet resistance to the standardized therapy there is a demand for reliable diagnostic tool for rapid and accurate assessment of platelet reactivity. TEG is an established technique to assess the quality of clot formation' used mainly in surgery and obstetrics to determine possible bleeding diathesis. Recently it became to be used in cardiology, where it can be a valuable tool to assess a response to antiplatelet therapy and its association with the outcome. However, there is a few data about use of TEG in STEMI patients undergoing PCI. Our study is designed to assess by TEG the platelet's response to clopidogrel treatment during acute STEMI in patients undergoing primary PCI and the correlation of this response with the long term outcome.

Study Design

Study Type:
Observational
Anticipated Enrollment :
50 participants
Observational Model:
Defined Population
Time Perspective:
Prospective
Study Start Date :
Aug 1, 2007
Anticipated Study Completion Date :
Feb 1, 2008

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 88 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • 18 years old STEMI patients admitted to ICCU and in whom the primary PCI is elected as treatment strategy would be enrolled

    Exclusion Criteria:
    • Patient received thrombolytic therapy, chronic renal failure (GFR<40 ml/min), any known hematological dyscrasia

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Asaf Harofeh MC Zerifin Israel 70300

    Sponsors and Collaborators

    • Assaf-Harofeh Medical Center

    Investigators

    • Study Director: Alex Blatt, MD, Cardiology Division, Assaf Harofeh Medical Center
    • Principal Investigator: Ilia Litovchik, MD, Cardiology Division, Assaf Harofeh Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00517478
    Other Study ID Numbers:
    • 98/07
    First Posted:
    Aug 17, 2007
    Last Update Posted:
    Aug 17, 2007
    Last Verified:
    Jul 1, 2007
    Additional relevant MeSH terms:
    Cardiovascular Diseases
    Myocardial Infarction
    Infarction

    Study Results

    No Results Posted as of Aug 17, 2007