Multiple Electrode Aggregometry & Clopidogrel Resistance

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. Identifier: NCT01991093
Recruitment Status : Completed
First Posted : November 25, 2013
Last Update Posted : March 17, 2015
Information provided by (Responsible Party):
Elpen Pharmaceutical Co. Inc.

Brief Summary:
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 or disease
Type 2 Diabetes Mellitus (T2DM) Coronary Artery Disease (CAD) Myocardial Infraction

  Show Detailed Description

Study Type : Observational
Actual Enrollment : 280 participants
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.
Study Start Date : June 2014
Actual Primary Completion Date : January 2015
Actual Study Completion Date : January 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. 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

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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

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

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 identifier (NCT number): NCT01991093

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.
Study Chair: Argirios Tsantes, MD, Ass Professor Head of Laboratory of Haematology & Blood Bank Unit, "Attiko" University General Hospital


Responsible Party: Elpen Pharmaceutical Co. Inc. Identifier: NCT01991093     History of Changes
Other Study ID Numbers: 2013-11-IIS
First Posted: November 25, 2013    Key Record Dates
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
Arterial Occlusive Diseases
Vascular Diseases
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