NCT02487732已完成4 期
Comparison of Ticagrelor vs. Prasugrel on Inflammation, Arterial Stiffness, Endothelial Function, and Circulating Endothelial Progenitor Cells in Diabetic Patients With Non-ST Elevation Acute Coronary Syndrome (NSTE-ACS) Requiring Coronary Stenting
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Changes in circulating number of endothelial progenitor cells
研究概览
简要总结
To investigate pleiotropic effects of ticagrelor in addition to its antiplatelet effects in type 2 diabetic patients with non-ST elevation acute coronary syndrome by measuring inflammatory markers, circulating number of endothelial progenitor cells, brachial artery endothelial function, and arterial stiffness.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provision of informed consent prior to any study specific procedures
- •Newly diagnosed type 2 diabetic patients or type 2 diabetic patients on hypoglycemic agents between the age of 30 to 70
- •Non-ST elevation Acute coronary syndrome with successful coronary stent implantation (with TIMI flow grade 3 after the procedure)
排除标准
- •Hypersensitivity to ticagrelor, prasugrel or any of the excipients
- •No prior use of either ticagrelor or prasugrel within a month prior to randomization.
- •History of intracranial bleeding at any time
- •Active pathologic bleeding
- •Hemoglobin A1c >9%
- •Type 1 diabetes
- •Decreased serum platelet level (< 100,000/uL)
- •Need for chronic oral anticoagulant therapy or chronic low-molecular-weight heparin
- •Gastrointestinal bleed within the past 6 months, or major surgery within 30 days
- •Renal failure requiring dialysis or anticipated need for dialysis during the course of the study
- •Any condition which in the opinion of the investigator would make it unsafe or unsuitable for the patient to participate in this study
- •Involvement in the planning and/or conduct of the study
- •Left ventricular ejection fraction < 40%
- •Hepatic dysfunction (aspartate aminotransferase or alanine aminotransferase > twice the upper limit)
- •Gastrointestinal disorder such as Crohn's disease
- •Alcohol abuse
- •Steroid or hormone replacement therapy
- •Serum creatinine > 2.0 mg/dL.
- •Prior history of CVA or stroke
- •Body weight < 60 kg
- •Life expectancy less than a year
- •Known pregnancy, breast-feeding, or intend to become pregnant during the study period
研究组 & 干预措施
Ticagrelor
Active Comparator
180mg loading dose, 90mg twice daily for 5 weeks, then crossover to prasugrel
干预措施: Ticagrelor (Drug)
Prasugrel
Active Comparator
60mg loading dose, 10mg once daily for 5 weeks, then crossover to ticagrelor
干预措施: Prasugrel (Drug)
结局指标
主要结局
Changes in circulating number of endothelial progenitor cells
时间窗: Expected average of 5 weeks
Changes in brachial artery flow mediated dilation
时间窗: Expected average of 5 weeks
次要结局
- Composite measure of brachial-ankle pulse wave velocity, and augmentation index.(Expected average of 5 weeks)
研究者
Soon Jun Hong
Associate Professor
Korea University Anam Hospital
研究点 (1)
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