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

Primary Purpose

Acute ST SEgment Elevation Myocardial Infarction

Status
Unknown status
Phase
Phase 3
Locations
Israel
Study Type
Interventional
Intervention
Aspirin (200mg) and/or Plavix (150mg) dosage according to TEG
Aspirin 100mg and Plavix 75mg
Sponsored by
Assaf-Harofeh Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Acute ST SEgment Elevation Myocardial Infarction focused on measuring Thromboelastography, Aspirin, Clopidogrel, Plavix, Resistance, Platelet, Coronary Stenting, Bare Metal Stent, Dual antiplatelet therapy, Overreactivity, Primary Coronary Intervention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Assaf Harofeh MC ICCURecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Other

Arm Label

1

2

Arm Description

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

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

Outcomes

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).

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.

Full Information

First Posted
June 10, 2008
Last Updated
June 12, 2008
Sponsor
Assaf-Harofeh Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00697021
Brief Title
Thromboelastography As An Assessment Tool for Possible Clopidogrel and Aspirin Resistance
Acronym
TEG
Official Title
Thromboelastography As An Assessment Tool for Possible Clopidogrel and Aspirin Resistance in The Patients Treated With Primary PCI for STEMI
Study Type
Interventional

2. Study Status

Record Verification Date
April 2008
Overall Recruitment Status
Unknown status
Study Start Date
June 2008 (undefined)
Primary Completion Date
June 2009 (Anticipated)
Study Completion Date
October 2009 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Assaf-Harofeh Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
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
Arm Title
2
Arm Type
Other
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Aspirin (200mg) and/or Plavix (150mg) dosage according to TEG
Intervention Description
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
Intervention Name(s)
Aspirin 100mg and Plavix 75mg
Intervention Description
Responders to standard dual antiplatelet therapy as observed by TEG analysis will continue standard doses of Aspirin and Plavix
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ilya Litovchik, MD
Phone
972-5-7734-5900
Email
ilitovchik@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Alex Blatt, MD
Phone
972-5-7734-5906
Email
blattalex@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ilya Litovchik, MD
Organizational Affiliation
Assaf Harofeh MC Heart Institue
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Alex Blatt, MD
Organizational Affiliation
Assaf Harofeh MC ICCU Head of the Department
Official's Role
Study Director
Facility Information:
Facility Name
Assaf Harofeh MC ICCU
City
Zerrifin
ZIP/Postal Code
73000
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ilya Litovchik, MD
Phone
972-5-7734-5900
Email
ilitovchik@gmail.com
First Name & Middle Initial & Last Name & Degree
Alex Blatt, MD
Phone
972-5-7734-5906
Email
blattalex@gmail.com
First Name & Middle Initial & Last Name & Degree
Ilya Litovchik, MD

12. IPD Sharing Statement

Citations:
Citation
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.
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Thromboelastography As An Assessment Tool for Possible Clopidogrel and Aspirin Resistance

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