Assessment of an Alpha-Glucosidase Inhibitor to Block Cardiac Events in Patients With Myocardial Infarction and IGT (ABC Study)
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|ClinicalTrials.gov Identifier: NCT00212017|
Recruitment Status : Unknown
Verified November 2007 by National Cerebral and Cardiovascular Center.
Recruitment status was: Recruiting
First Posted : September 21, 2005
Last Update Posted : November 8, 2007
|Condition or disease||Intervention/treatment||Phase|
|Impaired Glucose Tolerance Myocardial Infarction||Drug: voglibose||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||3000 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Japan Working Group for the Assessment That the Alpha-Glucosidase Inhibitor Blocks Cardiac Events in Patients With Myocardial Infarction and IGT|
|Study Start Date :||April 2005|
|Estimated Study Completion Date :||April 2009|
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00212017
|Contact: Masafumi Kitakaze, MD, PhD||81-6-6833-5012 ext email@example.com|
|Contact: Jiyoong Kim, MD||81-6-6833-5012 ext firstname.lastname@example.org|
|National Cardiovascular Center||Recruiting|
|Suita, Osaka, Japan, 565-8565|
|Contact: Masafumi Kitakaze, MD, PhD 81-6-6833-5012 ext 2225 email@example.com|
|Study Chair:||Masafumi Kitakaze, MD, PhD||National Cerebral and Cardiovascular Center|