Impact of Acarbose on Abnormal Glucose Regulation in Patients With Coronary Artery Disease (AAA Trial)
Multicenter Trial on Clinical Utility of Acarbose in Patients With Ischemic Heart Disease Accompanied by Abnormal Glucose Regulation
1 other identifier
interventional
150
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4 diabetes-mellitus
Started Apr 2009
Longer than P75 for phase_4 diabetes-mellitus
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 9, 2009
CompletedFirst Posted
Study publicly available on registry
March 10, 2009
CompletedStudy Start
First participant enrolled
April 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2013
CompletedJuly 18, 2012
July 1, 2012
2.9 years
March 9, 2009
July 17, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
sudden cardiac death, fatal or non-fatal myocardial infarction, coronary revascularization, admission due to heart failure, fatal or non-fatal stroke
one year
Study Arms (1)
Acarbose
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Patients who have been diagnosed with coronary artery disease, with type 2 diabetes or impaired glucose tolerance
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Dept. of Intern. Med., School of Dentistry, Aichi Gakuin University
Nagoya, 464-8650, Japan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tatsuaki Matsubara, MD, PhD
Department of Internal Medicine, School of Dentistry, Aichi Gakuin University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- professor
Study Record Dates
First Submitted
March 9, 2009
First Posted
March 10, 2009
Study Start
April 1, 2009
Primary Completion
March 1, 2012
Study Completion
March 1, 2013
Last Updated
July 18, 2012
Record last verified: 2012-07