Impact of Acarbose on Abnormal Glucose Regulation in Patients With Coronary Artery Disease (AAA Trial)
Information source: Aichi Gakuin University
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Diabetes Mellitus; Impaired Glucose Tolerance; Coronary Artery Disease
Intervention: acarbose (Drug)
Phase: Phase 4
Status: Not yet recruiting
Sponsored by: Aichi Gakuin University Official(s) and/or principal investigator(s):
Tatsuaki Matsubara, MD, PhD, Principal Investigator, Affiliation: Department of Internal Medicine, School of Dentistry, Aichi Gakuin University
Overall contact:
Tatsuaki Matsubara, MD, PhD, Phone: +81-52-759-2111, Email: matt@dpc.aichi-gakuin.ac.jp
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.
Clinical Details
Official title: Multicenter Trial on Clinical Utility of Acarbose in Patients With Ischemic Heart Disease Accompanied by Abnormal Glucose Regulation
Study design: Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Primary outcome: sudden cardiac death, fatal or non-fatal myocardial infarction, coronary revascularization, admission due to heart failure, fatal or non-fatal stroke
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.
Eligibility
Minimum age: 20 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Tatsuaki Matsubara, MD, PhD, Phone: +81-52-759-2111, Email: matt@dpc.aichi-gakuin.ac.jp
Dept. of Intern. Med., School of Dentistry, Aichi Gakuin University, Nagoya 464-8650, Japan
Additional Information
Starting date: April 2009
Ending date: March 2011
Last updated: March 9, 2009
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