The Japan Working Group for the Assessment That the Alpha-glucosidase Inhibitor Blocks Cardiac Events in Patients With Myocardial Infarction and IGT
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 3,000
- 试验地点
- 1
- 主要终点
- the time till the first cardiovascular composite endpoint of death from cardiovascular death, and hospitalization due to nonfatal myocardial infarction, nonfatal unstable angina[16], nonfatal stroke, or treatment with coronary revascularisation
研究概览
简要总结
The purpose of this study is to evaluate whether an alpha-glucosidase inhibitor, a drug for the suppression of postprandial hyperglycemia, could reduce the recurrence of myocardial infarction in patients with impaired glucose tolerance (IGT) and old myocardial infarction.
详细描述
Type 2 diabetes mellitus is a well-established risk factor for coronary heart disease and atherosclerotic change in the coronary artery develops subclinically in a state of impaired glucose tolerance (IGT). Recently postprandial hyperglycemia as a feature of impaired glucose tolerance is recognized as a significant risk factor for coronary heart disease. So we designed a prospective randomized multi-center trial named Assessment of an α-glucosidase-inhibitor to Block Cardiac Events in Patients With Myocardial Infarction and IGT (ABC study) to evaluate whether an α-Glucosidase Inhibitor, a drug for the suppression of postprandial hyperglycemia, could reduce the recurrence of myocardial infarction in patients with IGT and old myocardial infarction.
100 hospitals will participate in the ABC study. Patients with IGT who have a history of prior myocardial infarction are randomly allocated to receive α-Glucosidase Inhibitor (voglibose) or a standard diet and exercise treatment. The number of patients to be recruited is 3000 and this study will continue for at least 2 years. The primary end-points are:
- cardiovascular mortality and
- hospitalization for cardiovascular events.
Effects in suppression of new diabetes development will also be evaluated.
We should recognize IGT as an important therapeutic target to decrease the recurrence of cardiovascular events. The ABC study, a large scale multi-center trial in Japan, will provide us with new evidence on how to treat IGT patients with prior myocardial infarction.
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
- Single (Outcomes Assessor)
盲法说明
This is an open and blinded-endpoint study
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
- •Impaired glucose tolerance
- •History of myocardial infarction
排除标准
- •Type I diabetes
- •History of coronary artery bypass graft
- •Severe liver and/or kidney dysfunction
- •History of allergic response to drugs
- •Arteriosclerosis obliterans
研究组 & 干预措施
the voglibose group
Participants in the voglibose group were administered a voglibose tablet (0.2 mg) three times daily before meals.
干预措施: voglibose (Drug)
the control group
Participants assigned to the control group were treated only with diet and exercise therapy.
干预措施: diet and exercise therapy (Behavioral)
结局指标
主要结局
the time till the first cardiovascular composite endpoint of death from cardiovascular death, and hospitalization due to nonfatal myocardial infarction, nonfatal unstable angina[16], nonfatal stroke, or treatment with coronary revascularisation
时间窗: May 2005 and June 2012
the time till the first cardiovascular composite endpoint of death from the time till the first cardiovascular composite endpoint of death from cardiovascular death, and hospitalization due to nonfatal myocardial infarction, nonfatal unstable angina\[16\], nonfatal stroke, or treatment with coronary revascularisation
次要结局
- Hospitalization due to heart failure(May 2005 and June 2012)
- All cause mortality(May 2005 and June 2012)
- Progression of IGT to diabetes(May 2005 and June 2012)
- Development or deterioration of either hypertension or hyperlipidemia(May 2005 and June 2012)
- Deterioration of renal function(May 2005 and June 2012)
- Hospitalization due to coronary artery disease(May 2005 and June 2012)
- Hospitalization due to cerebrovascular disease(May 2005 and June 2012)
研究者
Masafumi Kitakaze
Director
National Cerebral and Cardiovascular Center, Japan