AzTrials
AzTrials

Acute ST SEgment Elevation Myocardial InfarctionPhase 3TEGNCT00697021

Thromboelastography As An Assessment Tool for Possible Clopidogrel and Aspirin Resistance

A Phase 3 study testing Aspirin (200mg) and/or Plavix (150mg) dosage according to TEG and Aspirin 100mg and Plavix 75mg in people with Acute ST SEgment Elevation Myocardial Infarction, run by Assaf-Harofeh Medical Center at 1 site in Israel.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Aspirin (200mg) and/or Plavix (150mg) dosage according to TEG and Aspirin 100mg and Plavix 75mg
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteIsrael
Study dates
Jun 2008to Oct 2009
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 13Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Ilya Litovchik, MD contact

972-5-7734-5900

ilitovchik@gmail.com

Alex Blatt, MD contact

972-5-7734-5906

blattalex@gmail.com

Israel1 site, 1 recruiting

  • Assaf Harofeh MC ICCU

    Zerrifin, 73000

    Ilya Litovchik, MD, 972-5-7734-5900, ilitovchik@gmail.com

    Alex Blatt, MD, 972-5-7734-5906, blattalex@gmail.com

    Recruiting

Other trials in Israel

About this study

Official title: Thromboelastography As An Assessment Tool for Possible Clopidogrel and Aspirin Resistance in The Patients Treated With Primary PCI for STEMI

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.

Read the 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.

Being tested
Aspirin (200mg) and/or Plavix (150mg) dosage according to TEG, Aspirin 100mg and Plavix 75mg
Keywords
Thromboelastography, Aspirin, Clopidogrel, Plavix, Resistance, Platelet, Coronary Stenting, Bare Metal Stent, Dual antiplatelet therapy, Overreactivity, Primary Coronary Intervention
Medical subject headings
ST Elevation Myocardial Infarction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

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

  • Aspirin 100mg and Plavix 75mgDrug

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

Study groups in NCT00697021
Study groupRoleWhat they receive
1Active comparatorPatients 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
Receives: Drug: Aspirin (200mg) and/or Plavix (150mg) dosage according to TEG
2OtherPatients 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
Receives: Drug: Aspirin 100mg and Plavix 75mg

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: 0ne year follow up

Secondary outcomes (1)

  1. To determine the correlation between platelet response to clopidogrel treatment and the outcome of patients who underwent percutaneous coronary intervention (PCI) for STEMI.

    Measured: one year follow up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jun 2008 (estimated)
  2. Study startJun 2008
  3. Primary completionJun 2009 (estimated)
  4. Study completionOct 2009 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00697021
Sponsor's protocol ID
57/08
Acronym
TEG
Status last verified
Apr 2008
First submitted
10 Jun 2008
Last updated
13 Jun 2008
Results posted
No
Data monitoring committee
Yes

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.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Aspirin (200mg) and/or Plavix (150mg) dosage according to TEG and Aspirin 100mg and Plavix 75mg in people with Acute ST SEgment Elevation Myocardial Infarction, run by Assaf-Harofeh Medical Center at 1 site in Israel.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 13 Jun 2008. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Ilya Litovchik, MD (972-5-7734-5900, ilitovchik@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00697021, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2008.

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