Assessment of an Alpha-glucosidase Inhibitor to Block Cardiac Events in Patients With MI and IGT

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Japan Working Group for the Assessment That the Alpha-glucosidase Inhibitor Blocks Cardiac Events in Patients With Myocardial Infarction and IGT

Conditions
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Impaired Glucose Tolerance, Myocardial Infarction

Intervention / Treatment
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* Drug: voglibose
* Behavioral: diet and exercise therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective, randomised, open, blinded-endpoint study
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: the voglibose group<br>Participants in the voglibose group were administered a voglibose tablet (0.2 mg) three times daily before meals. | Drug: voglibose<br> <br> |
| Active Comparator: the control group<br>Participants assigned to the control group were treated only with diet and exercise therapy. | Behavioral: diet and exercise therapy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | May 2005 and June 2012 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All cause mortality | All cause death | May 2005 and June 2012 | 
| Hospitalization due to coronary artery disease | Hospitalization due to coronary artery disease | May 2005 and June 2012 | 
| Progression of IGT to diabetes | Progression of IGT to diabetes | May 2005 and June 2012 | 
| Development or deterioration of either hypertension or hyperlipidemia | Development or deterioration of either hypertension or hyperlipidemia | May 2005 and June 2012 | 
| Deterioration of renal function | Deterioration of renal function | May 2005 and June 2012 | 
| Hospitalization due to cerebrovascular disease | Hospitalization due to cerebrovascular disease | May 2005 and June 2012 | 
| Hospitalization due to heart failure | Hospitalization due to heart failure | May 2005 and June 2012 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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IGT, Myocardial Infarction, alpha-glucosidase inhibitor, re-infarction prevention