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Assessment of an Alpha-Glucosidase Inhibitor to Block Cardiac Events in Patients With Myocardial Infarction and IGT (ABC Study)
This study is currently recruiting participants.
Verified by National Cardiovascular Center, Japan, November 2007
First Received: September 13, 2005   Last Updated: November 7, 2007   History of Changes
Sponsored by: National Cardiovascular Center, Japan
Information provided by: National Cardiovascular Center, Japan
ClinicalTrials.gov Identifier: NCT00212017
  Purpose

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

MedlinePlus related topics: Heart Attack
Drug Information available for: Voglibose
U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Randomized, Open Label, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title: The Japan Working Group for the Assessment That the Alpha-Glucosidase Inhibitor Blocks Cardiac Events in Patients With Myocardial Infarction and IGT

Further study details as provided by National Cardiovascular Center, Japan:

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.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00212017

Contacts
Contact: Masafumi Kitakaze, MD, PhD 81-6-6833-5012 ext 2225 kitakaze@zf6.so-net.ne.jp
Contact: Jiyoong Kim, MD 81-6-6833-5012 ext 8212 jikim@attglobal.net

Locations
Japan, Osaka
National Cardiovascular Center Recruiting
Suita, Osaka, Japan, 565-8565
Contact: Masafumi Kitakaze, MD, PhD     81-6-6833-5012 ext 2225     kitakaze@zf6.so-net.ne.jp    
Sponsors and Collaborators
National Cardiovascular Center, Japan
Investigators
Study Chair: Masafumi Kitakaze, MD, PhD National Cardiovascular Center
  More Information

No publications provided

Study ID Numbers: CSSCJ-3, UMIN_ID:C000000090
Study First Received: September 13, 2005
Last Updated: November 7, 2007
ClinicalTrials.gov Identifier: NCT00212017     History of Changes
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by National Cardiovascular Center, Japan:
IGT
Myocardial Infarction
alpha-glucosidase inhibitor
re-infarction prevention

Study placed in the following topic categories:
Heart Diseases
Metabolic Diseases
Myocardial Ischemia
Glucose Intolerance
Vascular Diseases
Ischemia
Necrosis
Hypoglycemic Agents
Hyperglycemia
Voglibose
Infarction
Glucose Metabolism Disorders
Myocardial Infarction
Metabolic Disorder

Additional relevant MeSH terms:
Heart Diseases
Metabolic Diseases
Myocardial Ischemia
Physiological Effects of Drugs
Glucose Intolerance
Vascular Diseases
Ischemia
Pharmacologic Actions
Necrosis
Hypoglycemic Agents
Pathologic Processes
Hyperglycemia
Voglibose
Cardiovascular Diseases
Infarction
Glucose Metabolism Disorders
Myocardial Infarction

ClinicalTrials.gov processed this record on May 07, 2009