TEG: Thromboelastography As An Assessment Tool for Possible Clopidogrel and Aspirin Resistance

Sponsor

Assaf-Harofeh Medical Center (Other)

Overall Status

Unknown status

CT.gov ID

NCT00697021

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

3.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Acute ST SEgment Elevation Myocardial Infarction	Drug: Aspirin (200mg) and/or Plavix (150mg) dosage according to TEG Drug: Aspirin 100mg and Plavix 75mg	Phase 3

Detailed Description

TEG system may provide the capabilities needed to deliver personalized therapy, first, because it can identify patients at risk of ischemic event based on hemostatic influences, particularly platelet aggregation and platelet reactivity. Secondly, because treating those patients who exhibit high platelet reactivity -- an indication that they are not reaching a therapeutic level -- with appropriate drugs and doses is expected to improve outcomes.

In this study that would be increased clopidogrel maintenance dosing (150 mg) or aspirin maintenance dosing to 200mg in an attempt to lower platelet reactivity below the 50th%ile, which we expect to also reduce their ischemic risk during the follow up period.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Thromboelastography As An Assessment Tool for Possible Clopidogrel and Aspirin Resistance in The Patients Treated With Primary PCI for STEMI

Study Start Date :

Jun 1, 2008

Anticipated Primary Completion Date :

Jun 1, 2009

Anticipated Study Completion Date :

Oct 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 1 Patients who suffered acute STEMI and were treated by PPCI and by Aspirin 100mg and Plavix 75mg and showed on treatment platelet over-reactivity observed by TEG system on the 5th day after admission to ICCU	Drug: Aspirin (200mg) and/or Plavix (150mg) dosage according to TEG Non- responders to Aspirin or Plavix shown on TEG analysis will be treated by doubling of Aspirin (200mg) and/or Plavix (150mg) dosage
Other: 2 Patients who suffered acute STEMI and were treated by PPCI and recieved by Aspirin 100mg and Plavix 75mg and showed platelet inhibition observed by TEG system on the 5th day after admission to ICCU	Drug: Aspirin 100mg and Plavix 75mg Responders to standard dual antiplatelet therapy as observed by TEG analysis will continue standard doses of Aspirin and Plavix

Arm

Intervention/Treatment

Active Comparator: 1

Patients who suffered acute STEMI and were treated by PPCI and by Aspirin 100mg and Plavix 75mg and showed on treatment platelet over-reactivity observed by TEG system on the 5th day after admission to ICCU

Drug: Aspirin (200mg) and/or Plavix (150mg) dosage according to TEG

Non- responders to Aspirin or Plavix shown on TEG analysis will be treated by doubling of Aspirin (200mg) and/or Plavix (150mg) dosage

Other: 2

Patients who suffered acute STEMI and were treated by PPCI and recieved by Aspirin 100mg and Plavix 75mg and showed platelet inhibition observed by TEG system on the 5th day after admission to ICCU

Drug: Aspirin 100mg and Plavix 75mg

Responders to standard dual antiplatelet therapy as observed by TEG analysis will continue standard doses of Aspirin and Plavix

Outcome Measures

Primary Outcome Measures

To determine usefulness of thromboelastography (TEG) as a valuable tool in assessing platelet response to clopidogrel treatment and post-treatment platelet reactivity during acute ST segment elevation myocardial infarction (STEMI). [0ne year follow up]

Secondary Outcome Measures

To determine the correlation between platelet response to clopidogrel treatment and the outcome of patients who underwent percutaneous coronary intervention (PCI) for STEMI. [one year follow up]