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

July 17, 2012 updated by: Tatsuaki Matsubara, MD, PhD, Aichi Gakuin University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Nagoya, Japan, 464-8650
        • Recruiting
        • Dept. of Intern. Med., School of Dentistry, Aichi Gakuin University
        • Contact:
          • Tatsuaki Matsubara, MD, PhD
          • Phone Number: +81-52-759-2111
        • Principal Investigator:
          • Tatsuaki Matsubara, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aichi Gakuin University

Investigators

  • Principal Investigator: Tatsuaki Matsubara, MD, PhD, Department of Internal Medicine, School of Dentistry, Aichi Gakuin University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2009

Primary Completion (Actual)

March 1, 2012

Study Completion (Anticipated)

March 1, 2013

Study Registration Dates

First Submitted

March 9, 2009

First Submitted That Met QC Criteria

March 9, 2009

First Posted (Estimate)

March 10, 2009

Study Record Updates

Last Update Posted (Estimate)

July 18, 2012

Last Update Submitted That Met QC Criteria

July 17, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AGU-75

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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