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

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

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

Study Overview

• Status: Unknown
• Conditions: Diabetes; Insulin Resistance; Amyloid; Clopidogrel 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.

• Study Type: Observational
• Enrollment (Anticipated): 120

Contacts and Locations

Study Locations

• Greece
  • Attiki
    • Chaidari, Attiki, Greece, 12462
      • General & University Hospital "Attikon"

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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%).

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
mots-c predicts cardiovascular mortality in diabetic with coronary artery disease	mots-c concentration in Diabetic with coronary artery disease treated with acetyl-salicylic and clopidogrel predicts cardiovascular mortality	2 year follow up
b amyloid predicts cardiovascular mortality in diabetic with coronary artery disease	b amyloid concentration in Diabetic with coronary artery disease treated with acetyl-salicylic and clopidogrel predicts cardiovascular mortality	2 year follow up
b amyloid predicts cardiovascular mortality in diabetic with coronary artery	Resistance to clopidogrel as defined by Light Transmission Aggregometry in diabetic with coronary artery disease treated with acetyl-salicylic and clopidogrel predicts cardiovascular mortality.	2 year follow up

Collaborators and Investigators

• Sponsor: University of Athens
• Investigators: Study Chair: Ignatios Ikonomidis, AssProfessor, University of Athens

Publications and helpful links

General Publications

• Ikonomidis I, Katogiannis K, Kyriakou E, Taichert M, Katsimaglis G, Tsoumani M, Andreadou I, Maratou E, Lambadiari V, Kousathana F, Papadopoulou A, Varlamos C, Plotas P, Parissis J, Stamatelopoulos K, Alexopoulos D, Dimitriadis G, Tsantes AE. beta-Amyloid and mitochondrial-derived peptide-c are additive predictors of adverse outcome to high-on-treatment platelet reactivity in type 2 diabetics with revascularized coronary artery disease. J Thromb Thrombolysis. 2020 Apr;49(3):365-376. doi: 10.1007/s11239-020-02060-4.

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2014
• Primary Completion (ANTICIPATED): December 31, 2019
• Study Completion (ANTICIPATED): December 31, 2021

Study Registration Dates

• First Submitted: July 18, 2019
• First Submitted That Met QC Criteria: July 19, 2019
• First Posted (ACTUAL): July 22, 2019

Study Record Updates

• Last Update Posted (ACTUAL): July 23, 2019
• Last Update Submitted That Met QC Criteria: July 20, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Proteostasis Deficiencies; Hyperinsulinism; Amyloidosis; Insulin Resistance
• Other Study ID Numbers: LTA_MOTS-c_bamyloid_DM_CAD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No