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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2007 by Assaf-Harofeh Medical Center.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00517478
First Posted: August 17, 2007
Last Update Posted: August 17, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Assaf-Harofeh Medical Center
  Purpose
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 Intervention
Myocardial Infarction Cardiovascular Disease Procedure: Blood Sample

Study Type: Observational
Study Design: Observational Model: Defined Population
Observational Model: Natural History
Time Perspective: Longitudinal
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by Assaf-Harofeh Medical Center:

Estimated Enrollment: 50
Study Start Date: August 2007
Estimated Study Completion Date: February 2008
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.
  Eligibility

Information from the National Library of Medicine

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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
  Contacts and Locations
Information from the National Library of Medicine

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
  More Information

ClinicalTrials.gov Identifier: NCT00517478     History of Changes
Other Study ID Numbers: 98/07
First Submitted: August 15, 2007
First Posted: August 17, 2007
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