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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 because the information has not been verified recently.
Verified November 2007 by National Cerebral and Cardiovascular Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Cerebral and Cardiovascular Center
ClinicalTrials.gov Identifier:
NCT00212017
First received: September 13, 2005
Last updated: November 7, 2007
Last verified: November 2007
History of Changes
  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

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:

U.S. FDA Resources

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.

  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
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 Cerebral and Cardiovascular Center
Investigators
Study Chair: Masafumi Kitakaze, MD, PhD National Cerebral and Cardiovascular Center
  More Information

No publications provided

ClinicalTrials.gov 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:
IGT
Myocardial Infarction
alpha-glucosidase inhibitor
re-infarction prevention

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

ClinicalTrials.gov processed this record on June 17, 2013