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

Diabetes Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04027712
• Other study ID #: LTA_MOTS-c_bamyloid_DM_CAD
• Status: Active, not recruiting
• Start date: January 1, 2014
• Est. completion date: December 31, 2021

Study information

• Verified date: July 2019
• Source: University of Athens
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 120
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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%).

Related Conditions & MeSH terms

• Amyloid
• Amyloidosis
• Clopidogrel Resistance
• Diabetes
• Insulin Resistance

Locations

Country	Name	City	State
Greece	General & University Hospital "Attikon"	Chaidari	Attiki

Sponsors (1)

Lead Sponsor	Collaborator
University of Athens

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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