Effect of Sarpogrelate, a Serotonin Receptor Antagonist, on Progression of Coronary Artery Disease
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Coronary artery disease assessed by cardiac computed tomography angiography
研究概览
简要总结
This is a prospective interventional study to assess the effect of sarpogrelate compared with aspirin in Korean type 2 diabetic patients with atherosclerosis.
详细描述
Type 2 diabetes has been increased exponentially, arousing serious economic, social and health repercussions. Also, macrovascular complications of diabetes such as myocardial infarct or stroke have been increased. Individuals with diabetes have a greater risk of cardiovascular disease (CVD), approximately two to four times than that of those without diabetes. Currently, the U.S. Food and Drug Administration requires demonstration that new anti-hyperglycemic agents do not increase cardiovascular risk. The comprehensive and multifactorial management in type 2 diabetes, which includes control of hypertension, dyslipidemia and obesity, is known to significantly reduce the risk of CVD as shown in Steno-2 study. However, most anti-diabetic agents currently used in clinical practice do not seem to provide enough cardiovascular protection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Type 2 diabetes with HbA1c ≥ 6.5% at screening visit
- •Male or female between 30 and 80 years of age
- •Coronary artery stenosis: 10-75% without no evidence of acute coronary syndrome
- •No history of previous myocardial infarction
排除标准
- •Systolic blood pressure / diastolic blood pressure > 160/110 mmHg
- •Congestive heart failure
- •Allergy to radiocontrast dye
- •Allergy to aspirin or sarpogrelate
- •Acute bleeding
- •History of ulcer bleeding
- •GOT/GPT > 100/100
- •Other antiplatelet medication
研究组 & 干预措施
Sarpogrelate + Aspirin
Sarpogrelate as an active drug
干预措施: Sarpogrelate (Drug)
Sarpogrelate + Aspirin
Sarpogrelate as an active drug
干预措施: Aspirin (Drug)
Aspirin alone
Aspirin as an active comparator
干预措施: Aspirin (Drug)
结局指标
主要结局
Coronary artery disease assessed by cardiac computed tomography angiography
时间窗: 6 months
次要结局
- Coronary artery calcium score assessed by cardiac computed tomography angiography(6 months)
- Coronary artery stenosis assessed by cardiac computed tomography angiography(6 months)
- Changes of plaque composition assessed by cardiac computed tomography angiography(6 months)
- Changes of Ankle-branchial index(6 months)
- Glucose metabolism assessed by glycated hemoglobin(6 months)
- Changes of plaque size assessed by cardiac computed tomography angiography(6 months)
- Lipid metabolism assessed by triglyceride and high density lipoprotein-cholesterol(6 months)
- Changes of pulse wave velocity(6 months)
研究者
Soo Lim
Associate Professor
Seoul National University Bundang Hospital