NCT00212017

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 3,000 (actual)
• Sponsor: National Cerebral and Cardiovascular Center, Japan · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Impaired Glucose Tolerance
• Myocardial Infarction

Interventions

Type	Name	Description
DRUG	voglibose
BEHAVIORAL	diet and exercise therapy

Timeline

• Start date: 2005-04-01
• Primary completion: 2012-06-01
• Completion: 2017-08-01
• First posted: 2005-09-21
• Last updated: 2018-08-22

Locations

1 site across 1 country: Japan