Clinical trial NCT00858676: Impact of Acarbose on Abnormal Glucose Regulation in Patients With Coronary Artery Disease (AAA Trial)
Official title: Multicenter Trial on Clinical Utility of Acarbose in Patients With Ischemic Heart Disease Accompanied by Abnormal Glucose Regulation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Diabetes Mellitus
Impaired Glucose Tolerance
Coronary Artery Disease
Keywords: acarbose
diabetes mellitus
impaired glucose tolerance
coronary artery disease
Lead sponsor: Aichi Gakuin University
Sponsor class: OTHER
First posted: 2009-03-10
Enrollment: 150
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: sudden cardiac death, fatal or non-fatal myocardial infarction, coronary revascularization, admission due to heart failure, fatal or non-fatal stroke
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Nagoya
country: Japan
facility: Dept. of Intern. Med., School of Dentistry, Aichi Gakuin University
Study officials:
affiliation: Department of Internal Medicine, School of Dentistry, Aichi Gakuin University
name: Tatsuaki Matsubara, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: