Impaired Glucose Tolerance, Myocardial Infarction
Conditions
Keywords
IGT, Myocardial Infarction, alpha-glucosidase inhibitor, re-infarction prevention
Brief summary
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
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: 1. cardiovascular mortality and 2. 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.
Interventions
DRUGvoglibose
BEHAVIORALdiet and exercise therapy
Sponsors
Ministry of Health, Labor and Welfare (Japan)
National Cerebral and Cardiovascular Center, Japan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Masking description
This is an open and blinded-endpoint study
Intervention model description
Prospective, randomised, open, blinded-endpoint study
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Impaired glucose tolerance 2. History of myocardial infarction
Exclusion criteria
1. Type I diabetes 2. History of coronary artery bypass graft 3. Severe liver and/or kidney dysfunction 4. History of allergic response to drugs 5. Arteriosclerosis obliterans
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hospitalization due to coronary artery disease | May 2005 and June 2012 | Hospitalization due to coronary artery disease |
| Progression of IGT to diabetes | May 2005 and June 2012 | Progression of IGT to diabetes |
| Development or deterioration of either hypertension or hyperlipidemia | May 2005 and June 2012 | Development or deterioration of either hypertension or hyperlipidemia |
| All cause mortality | May 2005 and June 2012 | All cause death |
| Hospitalization due to cerebrovascular disease | May 2005 and June 2012 | Hospitalization due to cerebrovascular disease |
| Hospitalization due to heart failure | May 2005 and June 2012 | Hospitalization due to heart failure |
| Deterioration of renal function | May 2005 and June 2012 | Deterioration of renal function |
Countries
Japan
Outcome results
None listed