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
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- mots-c predicts cardiovascular mortality in diabetic with coronary artery disease
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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%).
结局指标
主要结局
mots-c predicts cardiovascular mortality in diabetic with coronary artery disease
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
未报告次要终点
研究者
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
University of Athens