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NCT00517478 Clinical Trial

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

Myocardial Infarction Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT00517478
Other study ID # 98/07
Secondary ID
Status Not yet recruiting
Phase N/A
First received August 15, 2007
Last updated August 16, 2007
Start date August 2007
Est. completion date February 2008

Study information
Verified date July 2007
Source Assaf-Harofeh Medical Center
Contact Alex Blatt, MD
Phone 972-8-9779345
Email alexb@asaf.health.gov.il
Is FDA regulated No
Health authority Israel: Israeli Health Ministry Pharmaceutical Administration
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 50
Est. completion date February 2008
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 88 Years
Eligibility 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

Study Design

Observational Model: Defined Population, Time Perspective: Longitudinal

Related Conditions & MeSH terms

Intervention

Procedure:
• Blood Sample

Locations
Country Name City State
Israel Asaf Harofeh MC Zerifin

Sponsors (1)
Lead Sponsor Collaborator
Assaf-Harofeh Medical Center

Country where clinical trial is conducted

Israel, 

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