Assessment of an Alpha-Glucosidase Inhibitor to Block Cardiac Events in Patients With Myocardial Infarction and IGT (ABC Study)
Recruitment status was: Recruiting
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||The Japan Working Group for the Assessment That the Alpha-Glucosidase Inhibitor Blocks Cardiac Events in Patients With Myocardial Infarction and IGT|
- Cardiovascular mortality
- Hospitalization due to cardiovascular events
- All cause mortality
- Hospitalization due to coronary artery disease
- Progression of IGT to diabetes
- Development or deterioration of either hypertension or hyperlipidemia
- Deterioration of renal function
- Hospitalization due to cerebrovascular disease
- Hospitalization due to heart failure
|Study Start Date:||April 2005|
|Estimated Study Completion Date:||April 2009|
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:
- cardiovascular mortality and
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00212017
|National Cardiovascular Center|
|Suita, Osaka, Japan, 565-8565|
|Study Chair:||Masafumi Kitakaze, MD, PhD||National Cerebral and Cardiovascular Center|