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

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00858676
• Other study ID #: AGU-75
• Status: Recruiting
• Phase: Phase 4
• First received: March 9, 2009
• Last updated: July 17, 2012
• Start date: April 2009
• Est. completion date: March 2013

Study information

• Verified date: July 2012
• Source: Aichi Gakuin University
• Contact: Tatsuaki Matsubara, MD, PhD
• Phone: +81-52-759-2111
• Email: matt[@]dpc.aichi-gakuin.ac.jp
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: March 2013
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Diabetes Mellitus
• Glucose Intolerance
• Impaired Glucose Tolerance
• Myocardial Ischemia

Intervention

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

Locations

Country	Name	City	State
Japan	Dept. of Intern. Med., School of Dentistry, Aichi Gakuin University	Nagoya

Sponsors (1)

Lead Sponsor	Collaborator
Aichi Gakuin University

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	sudden cardiac death, fatal or non-fatal myocardial infarction, coronary revascularization, admission due to heart failure, fatal or non-fatal stroke		one year	Yes