Thromboelastography As An Assessment Tool for Possible Clopidogrel and Aspirin Resistance
Information source: Assaf-Harofeh Medical Center
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Acute ST SEgment Elevation Myocardial Infarction
Intervention: Aspirin (200mg) and/or Plavix (150mg) dosage according to TEG (Drug); Aspirin 100mg and Plavix 75mg (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: Assaf-Harofeh Medical Center Official(s) and/or principal investigator(s):
Ilya Litovchik, MD, Principal Investigator, Affiliation: Assaf Harofeh MC Heart Institue
Alex Blatt, MD, Study Director, Affiliation: Assaf Harofeh MC ICCU Head of the Department
Overall contact:
Ilya Litovchik, MD, Phone: 972-5-7734-5900, Email: ilitovchik@gmail.com
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.
Clinical Details
Official title: Thromboelastography As An Assessment Tool for Possible Clopidogrel and Aspirin Resistance in The Patients Treated With Primary PCI for STEMI
Study design: Prevention, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Primary outcome: 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).
Secondary outcome: To determine the correlation between platelet response to clopidogrel treatment and the outcome of patients who underwent percutaneous coronary intervention (PCI) for STEMI.
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Ilya Litovchik, MD, Phone: 972-5-7734-5900, Email: ilitovchik@gmail.com
Assaf Harofeh MC ICCU, Zerrifin 73000, Israel; Recruiting
Ilya Litovchik, MD, Phone: 972-5-7734-5900, Email: ilitovchik@gmail.com
Alex Blatt, MD, Phone: 972-5-7734-5906, Email: blattalex@gmail.com
Ilya Litovchik, MD, Principal Investigator
Additional Information
Related 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.
Starting date: June 2008
Ending date: October 2009
Last updated: June 12, 2008
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