Thromboelastography As An Assessment Tool for Possible Clopidogrel and Aspirin Resistance

NCT00697021 | Unknown Phase 3 DMC

• 1 other identifier: 57/08
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute ST SEgment Elevation Myocardial Infarction

Keywords

Thromboelastography; Aspirin; Clopidogrel; Plavix; Resistance; Platelet; Coronary Stenting; Bare Metal Stent; Dual antiplatelet therapy; Overreactivity; Primary Coronary Intervention

Outcome Measures

Primary Outcomes (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).

  0ne year follow up

Secondary Outcomes (1)

• 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

Study Arms (2)

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

2

OTHER

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

Interventions

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

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

1

Aspirin 100mg and Plavix 75mg DRUG

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

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assaf-Harofeh Medical Center: lead

Study Sites (1)

Assaf Harofeh MC ICCU

Zerrifin, 73000, Israel

RECRUITING

Related Publications (1)

• 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.

  BACKGROUND

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Interventions

Aspirin; Clopidogrel

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Ilya Litovchik, MD

  Assaf Harofeh MC Heart Institue

  PRINCIPAL INVESTIGATOR

• Alex Blatt, MD

  Assaf Harofeh MC ICCU Head of the Department

  STUDY DIRECTOR

Central Study Contacts

Ilya Litovchik, MD

CONTACT

972-5-7734-5900; ilitovchik@gmail.com

Alex Blatt, MD

CONTACT

972-5-7734-5906; blattalex@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: June 10, 2008
• First Posted: June 13, 2008
• Study Start: June 1, 2008
• Primary Completion: June 1, 2009
• Study Completion: October 1, 2009
• Last Updated: June 13, 2008

Record last verified: 2008-04

Locations

IL (1)