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

Sponsor

Aichi Gakuin University (Other)

Overall Status

Unknown status

CT.gov ID

NCT00858676

Collaborator

(none)

150

Enrollment

Location

Arm

Duration (Months)

3.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus Impaired Glucose Tolerance Coronary Artery Disease	Drug: acarbose	Phase 4

Detailed Description

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

150 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Apr 1, 2009

Actual Primary Completion Date :

Mar 1, 2012

Anticipated Study Completion Date :

Mar 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Acarbose	Drug: acarbose 50mg acarbose 3 times a day PO. duration: one year Other Names: Glucobay

Arm

Intervention/Treatment

Active Comparator: Acarbose

Drug: acarbose

50mg acarbose 3 times a day PO. duration: one year

Other Names:

Glucobay

Outcome Measures

Primary Outcome Measures

sudden cardiac death, fatal or non-fatal myocardial infarction, coronary revascularization, admission due to heart failure, fatal or non-fatal stroke [one year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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