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

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ClinicalTrials.gov Identifier: NCT00517478
Recruitment Status : Unknown
Verified July 2007 by Assaf-Harofeh Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : August 17, 2007
Last Update Posted : August 17, 2007
Sponsor:
Information provided by:
Assaf-Harofeh Medical Center

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
Myocardial Infarction Cardiovascular Disease 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 Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Defined Population
Observational Model: Natural History
Time Perspective: Longitudinal
Time Perspective: Prospective
Study Start Date : August 2007
Estimated Study Completion Date : February 2008

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Ages Eligible for Study:   18 Years to 88 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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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): NCT00517478


Contacts
Contact: Alex Blatt, MD 972-8-9779345 alexb@asaf.health.gov.il
Contact: Ilia Litovchik, MD 972-8-9779347 ilitovchik@gmail.com

Locations
Israel
Asaf Harofeh MC Not yet recruiting
Zerifin, Israel, 70300
Contact: Blatt Alex, MD    972-8-9779345    alexb@asaf.health.gov.il   
Principal Investigator: Blatt Alex, MD         
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

ClinicalTrials.gov Identifier: NCT00517478     History of Changes
Other Study ID Numbers: 98/07
First Posted: August 17, 2007    Key Record Dates
Last Update Posted: August 17, 2007
Last Verified: July 2007

Additional relevant MeSH terms:
Infarction
Cardiovascular Diseases
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Vascular Diseases