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Sponsored by: |
National Cardiovascular Center, Japan |
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Information provided by: | National Cardiovascular Center, Japan |
ClinicalTrials.gov Identifier: | NCT00212017 |
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 |
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Impaired Glucose Tolerance Myocardial Infarction |
Drug: voglibose |
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 |
Estimated Enrollment: | 3000 |
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:
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 |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
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 |
Study Chair: | Masafumi Kitakaze, MD, PhD | National Cardiovascular Center |
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 |
IGT Myocardial Infarction alpha-glucosidase inhibitor re-infarction prevention |
Heart Diseases Metabolic Diseases Myocardial Ischemia Glucose Intolerance Vascular Diseases Ischemia Necrosis |
Hypoglycemic Agents Hyperglycemia Voglibose Infarction Glucose Metabolism Disorders Myocardial Infarction Metabolic Disorder |
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 |