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

National Cerebral and Cardiovascular Center, Japan

Status: Terminated

Conditions: Impaired Glucose Tolerance; Myocardial Infarction

Treatments: Drug: voglibose; Behavioral: diet and exercise therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT00212017

CSSCJ-3

UMIN_ID:C000000090

Details and patient eligibility

About

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.

Full 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.

Enrollment: 3,000 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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3,000 participants in 2 patient groups

the voglibose group

Active Comparator group

Description:

Participants in the voglibose group were administered a voglibose tablet (0.2 mg) three times daily before meals.

Treatment:

Drug: voglibose

the control group

Active Comparator group

Description:

Participants assigned to the control group were treated only with diet and exercise therapy.

Treatment:

Behavioral: diet and exercise therapy