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

NCT ID: NCT04027712

Last Updated: 2019-07-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-01-01

Study Completion Date

2021-12-31

Brief Summary

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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

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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.

Conditions

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Diabetes Clopidogrel Resistance Amyloid Insulin Resistance

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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%).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Athens

OTHER

Sponsor Role lead

Responsible Party

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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

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ignatios Ikonomidis, AssProfessor

Role: STUDY_CHAIR

University of Athens

Locations

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General & University Hospital "Attikon"

Chaïdári, Attica, Greece

Site Status

Countries

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Greece

References

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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.

Reference Type DERIVED
PMID: 32052315 (View on PubMed)

Other Identifiers

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LTA_MOTS-c_bamyloid_DM_CAD

Identifier Type: -

Identifier Source: org_study_id

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