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Assessment of an Alpha-Glucosidase Inhibitor to Block Cardiac Events in Patients With Myocardial Infarction and IGT (ABC Study)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2007 by National Cerebral and Cardiovascular Center.
Recruitment status was:  Recruiting
Information provided by:
National Cerebral and Cardiovascular Center Identifier:
First received: September 13, 2005
Last updated: November 7, 2007
Last verified: November 2007
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.

Condition Intervention
Impaired Glucose Tolerance
Myocardial Infarction
Drug: voglibose

Study Type: Interventional
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

Resource links provided by NLM:

Further study details as provided by National Cerebral and Cardiovascular Center:

Primary Outcome Measures:
  • Cardiovascular mortality
  • Hospitalization due to cardiovascular events

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 3000
Study Start Date: April 2005
Estimated Study Completion Date: April 2009
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.


Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Genders Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00212017

National Cardiovascular Center
Suita, Osaka, Japan, 565-8565
Sponsors and Collaborators
National Cerebral and Cardiovascular Center
Study Chair: Masafumi Kitakaze, MD, PhD National Cerebral and Cardiovascular Center
  More Information Identifier: NCT00212017     History of Changes
Other Study ID Numbers: CSSCJ-3  UMIN_ID:C000000090 
Study First Received: September 13, 2005
Last Updated: November 7, 2007
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by National Cerebral and Cardiovascular Center:
Myocardial Infarction
alpha-glucosidase inhibitor
re-infarction prevention

Additional relevant MeSH terms:
Myocardial Infarction
Glucose Intolerance
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Glycoside Hydrolase Inhibitors
Hypoglycemic Agents
Physiological Effects of Drugs
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on January 14, 2017