Thromboelastography As An Assessment Tool for Possible Clopidogrel and Aspirin Resistance

NCT ID: NCT00697021

Last Updated: 2008-06-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-06-30
• Study Completion Date: 2009-10-31

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.

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.

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

Study Design

• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: DRUG

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

Group Type: OTHER

Aspirin 100mg and Plavix 75mg

Intervention Type: DRUG

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

Interventions

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

Intervention Type: 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

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assaf-Harofeh Medical Center

OTHER_GOV

Sponsor Role: lead

Responsible Party

Intensive Coronary Care Unit Assaf Harofeh MC

Principal Investigators

Ilya Litovchik, MD

Role: PRINCIPAL_INVESTIGATOR

Assaf Harofeh MC Heart Institue

Alex Blatt, MD

Role: STUDY_DIRECTOR

Assaf Harofeh MC ICCU Head of the Department

Locations

Assaf Harofeh MC ICCU

Zerrifin, , Israel

Site Status: RECRUITING

Countries

Israel

Central Contacts

Ilya Litovchik, MD

Role: CONTACT

Phone: 972-5-7734-5900

Email: ilitovchik@gmail.com

Alex Blatt, MD

Role: CONTACT

Phone: 972-5-7734-5906

Email: blattalex@gmail.com

Facility Contacts

Ilya Litovchik, MD

Role: primary

Alex Blatt, MD

Role: backup

References

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.

Reference Type: BACKGROUND

Other Identifiers

57/08

Identifier Type: -

Identifier Source: org_study_id