Multicenter Trial on Clinical Utility of Acarbose in Patients With Ischemic Heart Disease Accompanied by Abnormal Glucose Regulation
试验速览
- 阶段
- 4 期
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- sudden cardiac death, fatal or non-fatal myocardial infarction, coronary revascularization, admission due to heart failure, fatal or non-fatal stroke
研究概览
简要总结
The objective of this trial is to investigate the effect of early treatment of glucose toxicity with acarbose, a drug to control postprandial hyperglycemia, on the occurence of cardiovascular events and the inhibition of atherosclerosis.
详细描述
Acarbose suppresses the postprandial increase in plasma glucose levels by inhibiting the activities of alpha-amylase and alpha-glucosidase involved in digestion and absorption of carbohydrates in the intestine. A clinical study involving patients with type 2 diabetes demonstrated that acarbose decreased the post-load glucose level and improved glycosylated hemoglobin control. A prospective study involving patients with impaired glucose tolerance (IGT) demonstrated that acarbose inhibited progression to type 2 diabetes and significantly reduced the risk of cardiovascular diseases. It has also been reported that acarbose slows increase in the intima-media thickness and inhibits the progression of atherosclerosis. A significant proportion of patients with acute coronary syndrome and those with stable angina pectoris suffer from diabetes or IGT, and their prognosis is poor.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who have been diagnosed with coronary artery disease, with type 2 diabetes or impaired glucose tolerance
排除标准
- •Patients scheduled to undergo revascularization at the time of enrollment
- •Patients who are being treated with an oral hypoglycemic drug or an insulin preparation
- •Patients with a history of laparotomy of ileus
- •Pre- and postoperative patients or individuals with severe infection or serious trauma
- •Patients with gastrointestinal disorders such as diarrhea and vomiting
- •Patients with a history of hypersensitivity to acarbose
- •Pregnant or possibly pregnant women
- •Patients who are judged by the attending physician to be otherwise ineligible
研究组 & 干预措施
Acarbose
干预措施: acarbose (Drug)
结局指标
主要结局
sudden cardiac death, fatal or non-fatal myocardial infarction, coronary revascularization, admission due to heart failure, fatal or non-fatal stroke
时间窗: one year
次要结局
未报告次要终点
研究者
Tatsuaki Matsubara, MD, PhD
professor
Aichi Gakuin University