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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04027712

Enrollment

120

Registered

2019-07-22

Start date

2014-01-01

Completion date

2021-12-31

Last updated

2019-07-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Amyloid, Clopidogrel Resistance, Diabetes, Insulin Resistance

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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%).

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

Greece

Outcome results