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Platelet Reactivity, B-amyloid, MOTS-c and Mortality of Type II Diabetics With CAD

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.
 
ClinicalTrials.gov Identifier: NCT04027712
Recruitment Status : Unknown
Verified July 2019 by Ignatios Ikonomidis, University of Athens.
Recruitment status was:  Active, not recruiting
First Posted : July 22, 2019
Last Update Posted : July 23, 2019
Sponsor:
Information provided by (Responsible Party):
Ignatios Ikonomidis, University of Athens

Brief Summary:
Increased circulating b-amyloid and decreased Mitochondrial-derived peptide (MOTS-c), a peptide improving tissue insulin sensitivity, are reported in diabetes. The investigators plan to investigate the association of both biofactors with high on-clopidogrel platelet reactivity and cardiovascular mortality in type 2 diabetic patients with Coronary artery disease

Condition or disease
Diabetes Clopidogrel Resistance Amyloid Insulin Resistance

Detailed Description:
In type II diabetic patients with Coronary artery disease treated with clopidogrel and aspirin, the investigators plan to measure: i. maximum platelet aggregation to adenosine diphosphate (ADP) by Light Transmission Aggregometry (LTAmax), as a marker of on-clopidogrel treatment platelet reactivity ii. Malondialdehyde (MDA), as oxidative stress marker, Mitochondrial-derived peptide MOTS-c and b-amyloid. blood levels.

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Study Type : Observational
Estimated Enrollment : 120 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: High On-treatment Platelet Reactivity, Increased B-amyloid and Downregulation of MOTS-c Predict Mortality in Patients With Coronary Artery Disease and Type 2 Diabetes Mellitus: a 2-year Follow up Study
Actual Study Start Date : January 1, 2014
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. mots-c predicts cardiovascular mortality in diabetic with coronary artery disease [ Time Frame: 2 year follow up ]
    mots-c concentration in Diabetic with coronary artery disease treated with acetyl-salicylic and clopidogrel predicts cardiovascular mortality

  2. b amyloid predicts cardiovascular mortality in diabetic with coronary artery disease [ Time Frame: 2 year follow up ]
    b amyloid concentration in Diabetic with coronary artery disease treated with acetyl-salicylic and clopidogrel predicts cardiovascular mortality

  3. b amyloid predicts cardiovascular mortality in diabetic with coronary artery [ Time Frame: 2 year follow up ]
    Resistance to clopidogrel as defined by Light Transmission Aggregometry in diabetic with coronary artery disease treated with acetyl-salicylic and clopidogrel predicts cardiovascular mortality.


Biospecimen Retention:   Samples Without DNA
fresh plasma, frozen plasma


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
type 2 diabetic patients with coronary artery disease, documented by coronary angiography, both per os or/and parenteric antidiabetic medications and double antiplatelet therapy (DAPT), constituted by a daily dose of 100 mg acetylsalicylic acid per os and a daily dose of 75 mg clopidogrel per os should be prescribed to the patients for at least one month before inclusion in the stud
Criteria

Inclusion Criteria:

  • type 2 diabetic patients with coronary artery disease, documented by coronary angiography,
  • both per os or/and parenteral antidiabetic medications and double antiplatelet therapy (DAPT), constituted by a daily dose of 100 mg acetylsalicylic acid per os and a daily dose of 75 mg clopidogrel per os should be prescribed to the patients for at least one month before inclusion in the study

Exclusion Criteria:

  • abnormal renal function (creatinine> 2.5 mg / dl),
  • hepatic failure (bilirubin> 2 mg / dl),
  • active malignancy,
  • patients treated with drugs that affect platelet function, besides aspirin 100 mg qd and clopidogrel 75 mg qd,
  • patients with a history of hemorrhagic mood,
  • patients with thrombocytopenia (PLTs < 100x109 / L) and
  • anemia (HCT <28%).

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): NCT04027712


Locations
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Greece
General & University Hospital "Attikon"
Chaidari, Attiki, Greece, 12462
Sponsors and Collaborators
University of Athens
Investigators
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Study Chair: Ignatios Ikonomidis, AssProfessor University of Athens
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Ignatios Ikonomidis, Ignatios Ikonomidis,MD,PhD,FESC, Associate Professor of Cardiology, Director of Echocardiography and the Laboratory of Preventive Cardiology, 2nd Cardiology Department, National and Kapodistrian University of Athens, University of Athens
ClinicalTrials.gov Identifier: NCT04027712    
Other Study ID Numbers: LTA_MOTS-c_bamyloid_DM_CAD
First Posted: July 22, 2019    Key Record Dates
Last Update Posted: July 23, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Insulin Resistance
Amyloidosis
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Proteostasis Deficiencies