Clinical trial NCT04027712: Platelet Reactivity, B-amyloid, MOTS-c and Mortality of Type II Diabetics With CAD
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Diabetes
Clopidogrel Resistance
Amyloid
Insulin Resistance
Lead sponsor: University of Athens
Sponsor class: OTHER
First posted: 2019-07-22
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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

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.

Eligibility 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%).

Primary outcomes:
measure: mots-c predicts cardiovascular mortality in diabetic with coronary artery disease
timeFrame: 2 year follow up
measure: b amyloid predicts cardiovascular mortality in diabetic with coronary artery disease
timeFrame: 2 year follow up
measure: b amyloid predicts cardiovascular mortality in diabetic with coronary artery
timeFrame: 2 year follow up
Secondary outcomes:
Other outcomes:
Locations:
city: Chaidari
country: Greece
facility: General & University Hospital "Attikon"
state: Attiki
Study officials:
affiliation: University of Athens
name: Ignatios Ikonomidis, AssProfessor
role: STUDY_CHAIR
References:
citation: 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.