Thromboelastography As An Assessment Tool for Possible Clopidogrel and Aspirin Resistance - Full Text View

Sponsored by:	Assaf-Harofeh Medical Center
Information provided by:	Assaf-Harofeh Medical Center
ClinicalTrials.gov Identifier:	NCT00697021

Purpose

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	Intervention	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 III

MedlinePlus related topics: Heart Attack

Drug Information available for: Acetylsalicylic acid Clopidogrel Clopidogrel Bisulfate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Official Title:	Thromboelastography As An Assessment Tool for Possible Clopidogrel and Aspirin Resistance in The Patients Treated With Primary PCI for STEMI

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

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). [ Time Frame: 0ne year follow up ] [ Designated as safety issue: Yes ]

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. [ Time Frame: one year follow up ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	50
Study Start Date:	June 2008
Estimated Study Completion Date:	October 2009
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator 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
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

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00697021

Contacts

Contact: Ilya Litovchik, MD	972-5-7734-5900	ilitovchik@gmail.com
Contact: Alex Blatt, MD	972-5-7734-5906	blattalex@gmail.com

Locations

Israel
Assaf Harofeh MC ICCU	Recruiting
Zerrifin, Israel, 73000
Contact: Ilya Litovchik, MD 972-5-7734-5900 ilitovchik@gmail.com
Contact: Alex Blatt, MD 972-5-7734-5906 blattalex@gmail.com
Principal Investigator: Ilya Litovchik, MD

Sponsors and Collaborators

Assaf-Harofeh Medical Center

Investigators

Principal Investigator:	Ilya Litovchik, MD	Assaf Harofeh MC Heart Institue
Study Director:	Alex Blatt, MD	Assaf Harofeh MC ICCU Head of the Department

More Information

Publications:

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.

Responsible Party:	Intensive Coronary Care Unit Assaf Harofeh MC ( Alex Blatt MD )
Study ID Numbers:	57/08
Study First Received:	June 10, 2008
Last Updated:	June 12, 2008
ClinicalTrials.gov Identifier:	NCT00697021
Health Authority:	Israel: Ministry of Health

Keywords provided by Assaf-Harofeh Medical Center:

Thromboelastography
Aspirin
Clopidogrel
Plavix
Resistance
Platelet

Coronary Stenting
Bare Metal Stent
Dual antiplatelet therapy
Overreactivity
Primary Coronary Intervention

Study placed in the following topic categories:

Necrosis
Heart Diseases
Aspirin
Clopidogrel
Myocardial Ischemia

Vascular Diseases
Ischemia
Infarction
Myocardial Infarction

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Molecular Mechanisms of Pharmacological Action
Cyclooxygenase Inhibitors
Hematologic Agents
Physiological Effects of Drugs
Enzyme Inhibitors
Fibrinolytic Agents
Cardiovascular Agents
Pharmacologic Actions
Fibrin Modulating Agents
Pathologic Processes

Analgesics, Non-Narcotic
Sensory System Agents
Therapeutic Uses
Platelet Aggregation Inhibitors
Cardiovascular Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 15, 2009