COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

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

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. Identifier: NCT00697021
Recruitment Status : Unknown
Verified April 2008 by Assaf-Harofeh Medical Center.
Recruitment status was:  Recruiting
First Posted : June 13, 2008
Last Update Posted : June 13, 2008
Information provided by:
Assaf-Harofeh Medical Center

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated 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 : June 2008
Estimated Primary Completion Date : June 2009
Estimated Study Completion Date : October 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

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

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

Primary Outcome Measures :
  1. 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). [ Time Frame: 0ne year follow up ]

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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 identifier (NCT number): NCT00697021

Layout table for location contacts
Contact: Ilya Litovchik, MD 972-5-7734-5900
Contact: Alex Blatt, MD 972-5-7734-5906

Layout table for location information
Assaf Harofeh MC ICCU Recruiting
Zerrifin, Israel, 73000
Contact: Ilya Litovchik, MD    972-5-7734-5900   
Contact: Alex Blatt, MD    972-5-7734-5906   
Principal Investigator: Ilya Litovchik, MD         
Sponsors and Collaborators
Assaf-Harofeh Medical Center
Layout table for investigator information
Principal Investigator: Ilya Litovchik, MD Assaf Harofeh MC Heart Institue
Study Director: Alex Blatt, MD Assaf Harofeh MC ICCU Head of the Department
1. J Am Coll Cardiol. 2007 Feb 13;49(6):657-66. Epub 2007 Jan 26. Increased risk in patients with high platelet aggregation receiving chronic clopidogrel therapy undergoing percutaneous coronary intervention: is the current antiplatelet therapy adequate? Bliden KP, DiChiara J, Tantry US, Bassi AK, Chaganti SK, Gurbel PA. 2. J Am Coll Cardiol Vol. 49, No. 14, 2007 (1505-16) Variability in Individual Responsiveness to Clopidogrel Clinical Implications, Management, and Future Perspectives Dominick J. Angiolillo, MD, PHD, FACC,* Antonio Fernandez-Ortiz, MD, PHD,† Esther Bernardo, BSC,† Fernando Alfonso, MD, PHD,† Carlos Macaya, MD, PHD,† Theodore A. Bass, MD, FACC,* Marco A. Costa, MD, PHD, FACC* 3. Circulation. 2004 Jun 29;109(25):3171-5. Epub 2004 Jun 7. Clopidogrel resistance is associated with increased risk of recurrent atherothrombotic events in patients with acute myocardial infarction. Matetzky S, Shenkman B, Guetta V, Shechter M, Bienart R, Goldenberg I, Novikov I, Pres H, Savion N, Varon D, Hod H. 4. Ann Intern Med. 2007 Mar 20;146(6):434-41. Role of clopidogrel in managing atherothrombotic cardiovascular disease. Eshaghian S, Kaul S, Amin S, Shah PK, Diamond GA. 5. Eur Heart J. 2006 Oct;27(20):2420-5. Epub 2006 Sep 27. Low response to clopidogrel is associated with cardiovascular outcome after coronary stent implantation. Geisler T, Langer H, Wydymus M, Gohring K, Zurn C, Bigalke B, Stellos K, May AE, Gawaz M. 6. Curr Pharm Des. 2006;12(10):1261-9. Clopidogrel resistance: implications for coronary stenting. Gurbel PA, Lau WC, Bliden KP, Tantry US. 7. Semin Thromb Hemost. 2007 Mar;33(2):196-202. Variable response to clopidogrel in patients with coronary artery disease. Geisler T, Gawaz M. 8. Clin Res Cardiol. 2006 Feb;95(2):122-6. Epub 2006 Jan 19. Combined aspirin and clopidogrel resistance associated with recurrent coronary stent thrombosis. Templin C, Schaefer A, Stumme B, Drexler H, von Depka M. 9. Blood Coagul Fibrinolysis. 2007 Mar;18(2):187-92. Clinical relevance of aspirin resistance in patients with stable coronary artery disease: a prospective follow-up study (PROSPECTAR). Pamukcu B, Oflaz H, Onur I, Oncul A, Ozcan M, Umman B, Mercanoglu F, Meric M, Nisanci Y. 10. Am J Cardiol. 2006 Nov 20;98(10A):11N-17N. Epub 2006 Sep 28. Aspirin resistance or variable response or both? Cheng X, Chen WH, Simon DI.

Layout table for additonal information
Responsible Party: Alex Blatt MD, Intensive Coronary Care Unit Assaf Harofeh MC Identifier: NCT00697021    
Other Study ID Numbers: 57/08
First Posted: June 13, 2008    Key Record Dates
Last Update Posted: June 13, 2008
Last Verified: April 2008
Keywords provided by Assaf-Harofeh Medical Center:
Coronary Stenting
Bare Metal Stent
Dual antiplatelet therapy
Primary Coronary Intervention
Additional relevant MeSH terms:
Layout table for MeSH terms
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Myocardial Infarction
ST Elevation Myocardial Infarction
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors