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Multiple Electrode Aggregometry & Clopidogrel Resistance

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Elpen Pharmaceutical Co. Inc.
Sponsor:
Information provided by (Responsible Party):
Elpen Pharmaceutical Co. Inc.
ClinicalTrials.gov Identifier:
NCT01991093
First received: November 12, 2013
Last updated: August 18, 2014
Last verified: August 2014
  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)

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 ] [ Designated as safety issue: Yes ]
    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


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

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01991093

Locations
Greece
Laboratory of Haematology & Blood Bank Unit, "Attiko" University General Hospital Recruiting
Medical School, National & Kapodistrian University of Athens, Athens, Greece, 12462,
Contact: Argyris Tsantes, MD       atsantes@yahoo.gr   
Principal Investigator: Argiris Tsantes, MD, Ass Professor         
Sub-Investigator: Elias Kyriakou, MD         
2nd Cardiology Department, Not yet recruiting
University of Athens, Attikon Hospital, Haidari, Athens, Greece, 12462
Contact: Ignatios Ikonomidis, Ass. Prof., Member of EACVI    30 6944805732      
Principal Investigator: Ignatios Ikonomidis, MD, Ass Prof.,         
Attikon University Hospital Recruiting
Athens, Haidari, Greece
Contact: Ignatios Economidis, MD    00306944805742    atsantes@yahoo.com   
Contact    00306944805742    atsantes@yahoo.com   
Principal Investigator: Argyrios Tsantes, MD         
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:

Responsible Party: Elpen Pharmaceutical Co. Inc.
ClinicalTrials.gov Identifier: NCT01991093     History of Changes
Other Study ID Numbers: 2013-11-IIS
Study First Received: November 12, 2013
Last Updated: August 18, 2014
Health Authority: Greece: National Organization of Medicines

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

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

ClinicalTrials.gov processed this record on November 20, 2014