Thromboelastography As An Assessment Tool for Possible Clopidogrel and Aspirin Resistance

• Status: Unknown status
• Trial end date: 2009-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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, and ability to dose adjustment according to a specific measurement by TEG in order to prevent future MACE.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assaf-Harofeh Medical Center
• Treatments: Aspirin; Clopidogrel; Ticlopidine

Criteria

Inclusion Criteria:

• Patients 18 years of age or more

• Patients admitted with acute STEMI as a first Coronary event

• Duration of symptoms less than 12 hours

• PCI elected as a treatment of acute STEMI

• Informed consent signed

Exclusion Criteria:

• Thrombolytic therapy

• PCI not performed after diagnostic angiography (conservative treatment, CABG)

• DES used in PPCI

• Staged PCI procedures

• Previous clopidogrel treatment at any time for any reason

• Previous myocardial infarction

• Known bleeding diathesis of any kind

• Significant renal insufficiency (GFR<40 ml/min)

• LFT disturbances (Transaminase elevation more than x3 ULN)

• Significant anemia (Hb<10) or a need for blood transfusion

• Significant Thrombocytopenia (PLT Count < 150000)

• Known Clopidogrel allergy

• Known Active peptic disease