Effects of Acarbose Long-Term Therapy on Prevention of Cardiovascular Events in Abnormal Glucose Tolerance With Coronary Artery Disease (ALERT Study)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 300
- 试验地点
- 6
- 主要终点
- Cardiovascular event free survival time
研究概览
简要总结
The purpose of this study is to determine whether the intervention for newly diagnosed abnormal glucose tolerance after coronary stenting will improve the long-term clinical outcome.
详细描述
Recent studies have demonstrated that newly diagnosed abnormal glucose tolerance (AGT; diabetes mellitus and impaired glucose tolerance) are common among the patients with ischemic heart disease. Several large cohort studies indicate that people with prediabetic conditions, such as impaired glucose tolerance, have a raised risk of future cardiovascular disease. Intervention with acarbose can prevent myocardial infarction and cardiovascular disease in type 2 diabetic and IGT patients. However, the effect of acarbose to secondary prevention of myocardial infarction or cardiovascular events in patients with newly diagnosed AGT after coronary stenting remains unclear. The purpose of the present study is to determine whether the intervention to such abnormalities after coronary stenting will improve the long-term clinical outcome. This is a opened, randomized study to compare acarbose versus a standard lifestyle modification. Patients will have a 1:1 chance of receiving acarbose versus the standard lifestyle modification. There is some research evidence that suggests acarbose may improve clinical outcome in patients with type 2 diabetes and in IGT patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Within 8 weeks since implantation of coronary artery stents for stable angina pectoris or acute coronary syndrome.
- •Abnormal glucose tolerance according to a 75 g oral glucose tolerance test (OGTT).
- •HbA1c is less than 6.5%.
- •Age is between 20 and 75 years (at time of consent).
- •Patients who can give informed consent themselves in writing.
排除标准
- •Patients with abnormal glucose tolerance caused by other organic disorders such as pancreatitis, hemochromatosis, post pancreatectomy, hyperthyroidism, Cushing syndrome, Prader-Willi syndrome, etc.
- •Patients with planned angioplasty.
- •Patients with uncontrollable congestive heart failure.
- •Less than 6 months since last episode of cerebral infarction.
- •Patients who have received medication for diabetes mellitus before.
- •AST (GOT) exceeding 100 IU/L or ALT (GPT) exceeding 100 IU/L.
- •Creatinine exceeding 2 mg/dl.
- •Patients with a history of ileus or less than 6 months since celiotomy.
- •Pregnant women or those who plan to become pregnant, or are in the lactation period.
- •Habitual drinker (more than 100 ml/day of alcohol).
- •Patients with a history of gastrectomy.
- •Patients for whom it is impossible to follow up for 5 years.
- •Any other reason that the clinical supervisors or clinical researchers may have for considering a case unsuitable for the study.
结局指标
主要结局
Cardiovascular event free survival time
次要结局
- Conversion of abnormal glucose tolerance to type 2 diabetes
- All causes of death
- Occurrence of every cardiovascular event
- Occurrence of in-stent restenosis
- Change in fasting, 2-hour blood glucose and insulin level
- Change in homeostasis model assessment of insulin resistance
- Change in hemoglobin A1c (HbA1c)
- Change in lipid profile