We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Multiple Electrode Aggregometry & Clopidogrel Resistance

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01991093
First Posted: November 25, 2013
Last Update Posted: March 17, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Elpen Pharmaceutical Co. Inc.
  Purpose
Antiplatelet therapy with aspirin-clopidogrel reduces the risk of cardiovascular episodes after percutaneous coronary intervention (PCI) in patients with acute coronary syndromes. However, a significant number of patients experience recurrent events while on such therapy. The individual response to dual antiplatelet therapy is not uniform, and consistent findings across multiple investigations support the association between a lower degree of platelet inhibition, high on-treatment platelet reactivity, and the occurrence of atherothrombotic events [1, 2]. Particularly in diabetic patients, clopidogrel resistance is more prevalent compared with non-diabetics [3,4], which seems to contribute to the increased atherothrombotic risk in these patients compared with those without diabetes mellitus (DM) [5]. A number of platelet function instruments have now become available that are simple to use and can be utilized as point-of-care (POC) instruments in order to monitor antiplatelet therapy and potentially assess the risk of a recurrent event [6].

Condition
Type 2 Diabetes Mellitus (T2DM) Coronary Artery Disease (CAD) Myocardial Infraction

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: The Role of Multiple Electrode Aggregometry in Detection of Clopidogrel Resistance in Diabetic Patients With Coronary Artery Disease and Prediction of Clinical Outcomes. A Comparative-method, Non Interventional, Single Center Study.

Resource links provided by NLM:


Further study details as provided by Elpen Pharmaceutical Co. Inc.:

Primary Outcome Measures:
  • Multiple electrode aggregometry in detection of clopidogrel resistance [ Time Frame: 7 days ]
    Percentage of type 2 diabetes mellitus (T2DM) and coronary artery disease (CAD)patients who are detected as clopidogrel resistance and predict the clinical outcome in comparison with the light transmittance aggregometry (LTA), which is considered the gold standard of platelet function testing


Enrollment: 280
Study Start Date: June 2014
Study Completion Date: January 2015
Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
type 2 diabetes mellitus (T2DM) and coronary artery disease (CAD)patients who will be detected for clopidogrel resistance
Criteria

Inclusion Criteria:

  • type 2 diabetes mellitus (T2DM)
  • coronary artery disease (CAD)patients
  • males and females
  • patients who will be on clopidogrel treatment
  • patients treated with prasugler or ticagrelor after an ACS will also undergo platelet reactivity tests, will be followed-up to record the primary endpoint for one year and will serve as control group to patients treated with clopidogrel
  • patients who will sign the study informed consent form
  • patients who will comply with all study procedures

Exclusion Criteria:

  • patients who will not sign the study informed consent form
  • patients who will not comply with all study procedures
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01991093


Locations
Greece
Laboratory of Haematology & Blood Bank Unit, "Attiko" University General Hospital
Medical School, National & Kapodistrian University of Athens, Athens, Greece, 12462,
2nd Cardiology Department,
University of Athens, Attikon Hospital, Haidari, Athens, Greece, 12462
Attikon University Hospital
Athens, Haidari, Greece
Sponsors and Collaborators
Elpen Pharmaceutical Co. Inc.
Investigators
Study Chair: Argirios Tsantes, MD, Ass Professor Head of Laboratory of Haematology & Blood Bank Unit, "Attiko" University General Hospital
  More Information

Publications:
Geisler T, Langer H, Wydymus M, Göhring K, Zürn C, Bigalke B, Stellos K, May AE, Gawaz M. Low response to clopidogrel is associated with cardiovascular outcome after coronary stent implantation. Eur Heart J. 2006 Oct;27(20):2420-5. Epub 2006 Sep 27.
Sibbing D, Braun S, Morath T, Mehilli J, Vogt W, Schömig A, Kastrati A, von Beckerath N. Platelet reactivity after clopidogrel treatment assessed with point-of-care analysis and early drug-eluting stent thrombosis. J Am Coll Cardiol. 2009 Mar 10;53(10):849-56. doi: 10.1016/j.jacc.2008.11.030.
Angiolillo DJ, Fernandez-Ortiz A, Bernardo E, Ramírez C, Sabaté M, Jimenez-Quevedo P, Hernández R, Moreno R, Escaned J, Alfonso F, Bañuelos C, Costa MA, Bass TA, Macaya C. Platelet function profiles in patients with type 2 diabetes and coronary artery disease on combined aspirin and clopidogrel treatment. Diabetes. 2005 Aug;54(8):2430-5.
Geisler T, Anders N, Paterok M, Langer H, Stellos K, Lindemann S, Herdeg C, May AE, Gawaz M. Platelet response to clopidogrel is attenuated in diabetic patients undergoing coronary stent implantation. Diabetes Care. 2007 Feb;30(2):372-4.
Angiolillo DJ. Antiplatelet therapy in diabetes: efficacy and limitations of current treatment strategies and future directions. Diabetes Care. 2009 Apr;32(4):531-40. doi: 10.2337/dc08-2064. Review.
Price MJ. Bedside evaluation of thienopyridine antiplatelet therapy. Circulation. 2009 May 19;119(19):2625-32. doi: 10.1161/CIRCULATIONAHA.107.696732. Review.
Harrison P, Frelinger AL 3rd, Furman MI, Michelson AD. Measuring antiplatelet drug effects in the laboratory. Thromb Res. 2007;120(3):323-36. Epub 2007 Jan 17. Review.
James S, Akerblom A, Cannon CP, Emanuelsson H, Husted S, Katus H, Skene A, Steg PG, Storey RF, Harrington R, Becker R, Wallentin L. Comparison of ticagrelor, the first reversible oral P2Y(12) receptor antagonist, with clopidogrel in patients with acute coronary syndromes: Rationale, design, and baseline characteristics of the PLATelet inhibition and patient Outcomes (PLATO) trial. Am Heart J. 2009 Apr;157(4):599-605. doi: 10.1016/j.ahj.2009.01.003.
Tsantes AE, Dimoula A, Bonovas S, Mantzios G, Tsirigotis P, Zoi K, Kalamara E, Kardoulaki A, Sitaras N, Travlou A, Dervenoulas J, Vaiopoulos G. The role of the Platelet Function Analyzer (PFA)-100 and platelet aggregometry in the differentiation of essential thrombocythemia from reactive thrombocytosis. Thromb Res. 2010 Feb;125(2):142-6. doi: 10.1016/j.thromres.2009.06.030. Epub 2009 Aug 7.
Gurbel PA, Antonino MJ, Bliden KP, Dichiara J, Suarez TA, Singla A, Tantry US. Platelet reactivity to adenosine diphosphate and long-term ischemic event occurrence following percutaneous coronary intervention: a potential antiplatelet therapeutic target. Platelets. 2008 Dec;19(8):595-604. doi: 10.1080/09537100802351065.
Bonello L, Tantry US, Marcucci R, Blindt R, Angiolillo DJ, Becker R, Bhatt DL, Cattaneo M, Collet JP, Cuisset T, Gachet C, Montalescot G, Jennings LK, Kereiakes D, Sibbing D, Trenk D, Van Werkum JW, Paganelli F, Price MJ, Waksman R, Gurbel PA; Working Group on High On-Treatment Platelet Reactivity. Consensus and future directions on the definition of high on-treatment platelet reactivity to adenosine diphosphate. J Am Coll Cardiol. 2010 Sep 14;56(12):919-33. doi: 10.1016/j.jacc.2010.04.047.
Angiolillo DJ, Bernardo E, Ramírez C, Costa MA, Sabaté M, Jimenez-Quevedo P, Hernández R, Moreno R, Escaned J, Alfonso F, Bañuelos C, Bass TA, Macaya C, Fernandez-Ortiz A. Insulin therapy is associated with platelet dysfunction in patients with type 2 diabetes mellitus on dual oral antiplatelet treatment. J Am Coll Cardiol. 2006 Jul 18;48(2):298-304. Epub 2006 Jun 22.
Yusuf S, Zhao F, Mehta SR, Chrolavicius S, Tognoni G, Fox KK; Clopidogrel in Unstable Angina to Prevent Recurrent Events Trial Investigators. Effects of clopidogrel in addition to aspirin in patients with acute coronary syndromes without ST-segment elevation. N Engl J Med. 2001 Aug 16;345(7):494-502. Erratum in: N Engl J Med 2001 Nov 15;345(20):1506. N Engl J Med 2001 Dec 6;345(23):1716.
Angiolillo DJ, Bernardo E, Sabaté M, Jimenez-Quevedo P, Costa MA, Palazuelos J, Hernández-Antolin R, Moreno R, Escaned J, Alfonso F, Bañuelos C, Guzman LA, Bass TA, Macaya C, Fernandez-Ortiz A. Impact of platelet reactivity on cardiovascular outcomes in patients with type 2 diabetes mellitus and coronary artery disease. J Am Coll Cardiol. 2007 Oct 16;50(16):1541-7. Epub 2007 Oct 1.
Angiolillo DJ, Shoemaker SB, Desai B, Yuan H, Charlton RK, Bernardo E, Zenni MM, Guzman LA, Bass TA, Costa MA. Randomized comparison of a high clopidogrel maintenance dose in patients with diabetes mellitus and coronary artery disease: results of the Optimizing Antiplatelet Therapy in Diabetes Mellitus (OPTIMUS) study. Circulation. 2007 Feb 13;115(6):708-16. Epub 2007 Jan 29.
Erlinge D, Varenhorst C, Braun OO, James S, Winters KJ, Jakubowski JA, Brandt JT, Sugidachi A, Siegbahn A, Wallentin L. Patients with poor responsiveness to thienopyridine treatment or with diabetes have lower levels of circulating active metabolite, but their platelets respond normally to active metabolite added ex vivo. J Am Coll Cardiol. 2008 Dec 9;52(24):1968-77. doi: 10.1016/j.jacc.2008.07.068.
Angiolillo DJ, Badimon JJ, Saucedo JF, Frelinger AL, Michelson AD, Jakubowski JA, Zhu B, Ojeh CK, Baker BA, Effron MB. A pharmacodynamic comparison of prasugrel vs. high-dose clopidogrel in patients with type 2 diabetes mellitus and coronary artery disease: results of the Optimizing anti-Platelet Therapy In diabetes MellitUS (OPTIMUS)-3 Trial. Eur Heart J. 2011 Apr;32(7):838-46. doi: 10.1093/eurheartj/ehq494. Epub 2011 Jan 20.

Responsible Party: Elpen Pharmaceutical Co. Inc.
ClinicalTrials.gov Identifier: NCT01991093     History of Changes
Other Study ID Numbers: 2013-11-IIS
First Submitted: November 12, 2013
First Posted: November 25, 2013
Last Update Posted: March 17, 2015
Last Verified: March 2015

Keywords provided by Elpen Pharmaceutical Co. Inc.:
light transmittance aggregometry (LTA),multiple electrode aggregometry, clopidogrel-resistance

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Clopidogrel
Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs


To Top