Impact of Acarbose on Abnormal Glucose Regulation in Patients With Coronary Artery Disease (AAA Trial)

Study Overview
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Brief Summary
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The objective of this trial is to investigate the effect of early treatment of glucose toxicity with acarbose, a drug to control postprandial hyperglycemia, on the occurence of cardiovascular events and the inhibition of atherosclerosis.

Detailed Description
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Acarbose suppresses the postprandial increase in plasma glucose levels by inhibiting the activities of alpha-amylase and alpha-glucosidase involved in digestion and absorption of carbohydrates in the intestine. A clinical study involving patients with type 2 diabetes demonstrated that acarbose decreased the post-load glucose level and improved glycosylated hemoglobin control. A prospective study involving patients with impaired glucose tolerance (IGT) demonstrated that acarbose inhibited progression to type 2 diabetes and significantly reduced the risk of cardiovascular diseases. It has also been reported that acarbose slows increase in the intima-media thickness and inhibits the progression of atherosclerosis. A significant proportion of patients with acute coronary syndrome and those with stable angina pectoris suffer from diabetes or IGT, and their prognosis is poor.

Official Title
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Multicenter Trial on Clinical Utility of Acarbose in Patients With Ischemic Heart Disease Accompanied by Abnormal Glucose Regulation

Conditions
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Diabetes Mellitus, Impaired Glucose Tolerance, Coronary Artery Disease

Intervention / Treatment
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* Drug: acarbose


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who have been diagnosed with coronary artery disease, with type 2 diabetes or impaired glucose tolerance Exclusion Criteria: Patients scheduled to undergo revascularization at the time of enrollment Patients who are being treated with an oral hypoglycemic drug or an insulin preparation Patients with a history of laparotomy of ileus Pre- and postoperative patients or individuals with severe infection or serious trauma Patients with gastrointestinal disorders such as diarrhea and vomiting Patients with a history of hypersensitivity to acarbose Pregnant or possibly pregnant women Patients who are judged by the attending physician to be otherwise ineligible

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Acarbose<br> | Drug: acarbose<br>* 50mg acarbose 3 times a day PO. duration: one year<br>* Other names: Glucobay;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sudden cardiac death, fatal or non-fatal myocardial infarction, coronary revascularization, admission due to heart failure, fatal or non-fatal stroke |  | one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acarbose, diabetes mellitus, impaired glucose tolerance, coronary artery disease