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

• Conditions: Clopidogrel Resistance; Diabetes; Insulin Resistance; Amyloid

• Registration Number: NCT04027712
• Lead Sponsor: 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

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 Timeline

• Study Start: 2014-01-01
• Status Verified: 2019-07
• Study First Submitted: 2019-07-18
• Study First Submitted QC: 2019-07-19
• Last Update Submitted: 2019-07-20
• Study First Posted: 2019-07-22
• Last Update Posted: 2019-07-23
• Primary Completion: 2019-12-31
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
mots-c predicts cardiovascular mortality in diabetic with coronary artery disease	2 year follow up	mots-c concentration in Diabetic with coronary artery disease treated with acetyl-salicylic and clopidogrel predicts cardiovascular mortality
b amyloid predicts cardiovascular mortality in diabetic with coronary artery disease	2 year follow up	b amyloid concentration in Diabetic with coronary artery disease treated with acetyl-salicylic and clopidogrel predicts cardiovascular mortality
b amyloid predicts cardiovascular mortality in diabetic with coronary artery	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.

Trial Locations

Locations (1)

General & University Hospital "Attikon"; 🇬🇷 Chaidari, Attiki, Greece