Assessment of an Alpha-glucosidase Inhibitor to Block Cardiac Events in Patients With MI and IGT
- Conditions
- Myocardial InfarctionImpaired Glucose Tolerance
- Interventions
- Behavioral: diet and exercise therapy
- Registration Number
- NCT00212017
- Lead Sponsor
- National Cerebral and Cardiovascular Center, Japan
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 3000
- Impaired glucose tolerance
- History of myocardial infarction
- Type I diabetes
- History of coronary artery bypass graft
- Severe liver and/or kidney dysfunction
- History of allergic response to drugs
- Arteriosclerosis obliterans
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description the control group diet and exercise therapy Participants assigned to the control group were treated only with diet and exercise therapy. the voglibose group voglibose Participants in the voglibose group were administered a voglibose tablet (0.2 mg) three times daily before meals.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Hospitalization due to heart failure May 2005 and June 2012 Hospitalization due to heart failure
All cause mortality May 2005 and June 2012 All cause death
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
Deterioration of renal function May 2005 and June 2012 Deterioration of renal function
Hospitalization due to coronary artery disease May 2005 and June 2012 Hospitalization due to coronary artery disease
Hospitalization due to cerebrovascular disease May 2005 and June 2012 Hospitalization due to cerebrovascular disease
Trial Locations
- Locations (1)
National Cardiovascular Center
🇯🇵Suita, Osaka, Japan