Assessment of an Alpha-glucosidase Inhibitor to Block Cardiac Events in Patients With MI and IGT
The Japan Working Group for the Assessment That the Alpha-glucosidase Inhibitor Blocks Cardiac Events in Patients With Myocardial Infarction and IGT
研究概览
详细说明
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.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Osaka
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Suita、Osaka、日本、565-8565
- National Cardiovascular Center
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Impaired glucose tolerance
- History of myocardial infarction
Exclusion Criteria:
- Type I diabetes
- History of coronary artery bypass graft
- Severe liver and/or kidney dysfunction
- History of allergic response to drugs
- Arteriosclerosis obliterans
学习计划
研究是如何设计的?
设计细节
- 主要用途:预防
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器:the voglibose group
Participants in the voglibose group were administered a voglibose tablet (0.2 mg) three times daily before meals.
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有源比较器:the control group
Participants assigned to the control group were treated only with diet and exercise therapy.
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
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
大体时间:May 2005 and June 2012
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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
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May 2005 and June 2012
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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All cause mortality
大体时间:May 2005 and June 2012
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All cause death
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May 2005 and June 2012
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Hospitalization due to coronary artery disease
大体时间:May 2005 and June 2012
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Hospitalization due to coronary artery disease
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May 2005 and June 2012
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Progression of IGT to diabetes
大体时间:May 2005 and June 2012
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Progression of IGT to diabetes
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May 2005 and June 2012
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Development or deterioration of either hypertension or hyperlipidemia
大体时间:May 2005 and June 2012
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Development or deterioration of either hypertension or hyperlipidemia
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May 2005 and June 2012
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Deterioration of renal function
大体时间:May 2005 and June 2012
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Deterioration of renal function
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May 2005 and June 2012
|
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Hospitalization due to cerebrovascular disease
大体时间:May 2005 and June 2012
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Hospitalization due to cerebrovascular disease
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May 2005 and June 2012
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Hospitalization due to heart failure
大体时间:May 2005 and June 2012
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Hospitalization due to heart failure
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May 2005 and June 2012
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合作者和调查者
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- CSSCJ-3
- UMIN_ID:C000000090
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
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