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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
3,000
National Cardiovascular Center
Suita, Osaka, Japan
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
Time frame: May 2005 and June 2012
All cause mortality
All cause death
Time frame: May 2005 and June 2012
Hospitalization due to coronary artery disease
Hospitalization due to coronary artery disease
Time frame: May 2005 and June 2012
Progression of IGT to diabetes
Progression of IGT to diabetes
Time frame: May 2005 and June 2012
Development or deterioration of either hypertension or hyperlipidemia
Development or deterioration of either hypertension or hyperlipidemia
Time frame: May 2005 and June 2012
Deterioration of renal function
Deterioration of renal function
Time frame: May 2005 and June 2012
Hospitalization due to cerebrovascular disease
Hospitalization due to cerebrovascular disease
Time frame: May 2005 and June 2012
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Hospitalization due to heart failure
Hospitalization due to heart failure
Time frame: May 2005 and June 2012