Back to resultsAcarbose and Secondary Prevention After Coronary Stenting
Primary Purpose
Glucose Metabolism Disorders, Coronary Artery Disease
Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Acarbose
Sponsored by
About this trial
This is an interventional prevention trial for Glucose Metabolism Disorders focused on measuring Abnormal Glucose Tolerance, coronary artery disease, diabetes mellitus, clinical outcome
Eligibility Criteria
Inclusion Criteria: Within 8 weeks since implantation of coronary artery stents for stable angina pectoris or acute coronary syndrome. Abnormal glucose tolerance according to a 75 g oral glucose tolerance test (OGTT). HbA1c is less than 6.5%. Age is between 20 and 75 years (at time of consent). Patients who can give informed consent themselves in writing. Exclusion Criteria: Patients with abnormal glucose tolerance caused by other organic disorders such as pancreatitis, hemochromatosis, post pancreatectomy, hyperthyroidism, Cushing syndrome, Prader-Willi syndrome, etc. Patients with planned angioplasty. Patients with uncontrollable congestive heart failure. Less than 6 months since last episode of cerebral infarction. Patients who have received medication for diabetes mellitus before. AST (GOT) exceeding 100 IU/L or ALT (GPT) exceeding 100 IU/L. Creatinine exceeding 2 mg/dl. Patients with a history of ileus or less than 6 months since celiotomy. Pregnant women or those who plan to become pregnant, or are in the lactation period. Habitual drinker (more than 100 ml/day of alcohol). Patients with a history of gastrectomy. Patients for whom it is impossible to follow up for 5 years. Any other reason that the clinical supervisors or clinical researchers may have for considering a case unsuitable for the study.
Sites / Locations
- Institute of Biomedical Research and Innovation.
- Kobe City General Hospital/Institute of Biomedical Research and Innovation
- Kawasaki Medical School Hospital
Outcomes
Primary Outcome Measures
Cardiovascular event free survival time
Secondary Outcome Measures
Conversion of abnormal glucose tolerance to type 2 diabetes
All causes of death
Occurrence of every cardiovascular event
Occurrence of in-stent restenosis
Change in fasting, 2-hour blood glucose and insulin level
Change in homeostasis model assessment of insulin resistance
Change in hemoglobin A1c (HbA1c)
Change in lipid profile
Full Information
NCT ID
NCT00221156
First Posted
September 13, 2005
Last Updated
June 23, 2009
Sponsor
Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
Collaborators
Institute of Biomedical Research and Innovation, Kobe, Hyogo, Japan, Kobe City General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00221156
Brief Title
Acarbose and Secondary Prevention After Coronary Stenting
Official Title
Effects of Acarbose Long-Term Therapy on Prevention of Cardiovascular Events in Abnormal Glucose Tolerance With Coronary Artery Disease (ALERT Study)
Study Type
Interventional
2. Study Status
Record Verification Date
June 2009
Overall Recruitment Status
Completed
Study Start Date
May 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
Collaborators
Institute of Biomedical Research and Innovation, Kobe, Hyogo, Japan, Kobe City General Hospital
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to determine whether the intervention for newly diagnosed abnormal glucose tolerance after coronary stenting will improve the long-term clinical outcome.
Detailed Description
Recent studies have demonstrated that newly diagnosed abnormal glucose tolerance (AGT; diabetes mellitus and impaired glucose tolerance) are common among the patients with ischemic heart disease. Several large cohort studies indicate that people with prediabetic conditions, such as impaired glucose tolerance, have a raised risk of future cardiovascular disease. Intervention with acarbose can prevent myocardial infarction and cardiovascular disease in type 2 diabetic and IGT patients. However, the effect of acarbose to secondary prevention of myocardial infarction or cardiovascular events in patients with newly diagnosed AGT after coronary stenting remains unclear. The purpose of the present study is to determine whether the intervention to such abnormalities after coronary stenting will improve the long-term clinical outcome. This is a opened, randomized study to compare acarbose versus a standard lifestyle modification. Patients will have a 1:1 chance of receiving acarbose versus the standard lifestyle modification. There is some research evidence that suggests acarbose may improve clinical outcome in patients with type 2 diabetes and in IGT patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glucose Metabolism Disorders, Coronary Artery Disease
Keywords
Abnormal Glucose Tolerance, coronary artery disease, diabetes mellitus, clinical outcome
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Acarbose
Primary Outcome Measure Information:
Title
Cardiovascular event free survival time
Secondary Outcome Measure Information:
Title
Conversion of abnormal glucose tolerance to type 2 diabetes
Title
All causes of death
Title
Occurrence of every cardiovascular event
Title
Occurrence of in-stent restenosis
Title
Change in fasting, 2-hour blood glucose and insulin level
Title
Change in homeostasis model assessment of insulin resistance
Title
Change in hemoglobin A1c (HbA1c)
Title
Change in lipid profile
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Within 8 weeks since implantation of coronary artery stents for stable angina pectoris or acute coronary syndrome.
Abnormal glucose tolerance according to a 75 g oral glucose tolerance test (OGTT).
HbA1c is less than 6.5%.
Age is between 20 and 75 years (at time of consent).
Patients who can give informed consent themselves in writing.
Exclusion Criteria:
Patients with abnormal glucose tolerance caused by other organic disorders such as pancreatitis, hemochromatosis, post pancreatectomy, hyperthyroidism, Cushing syndrome, Prader-Willi syndrome, etc.
Patients with planned angioplasty.
Patients with uncontrollable congestive heart failure.
Less than 6 months since last episode of cerebral infarction.
Patients who have received medication for diabetes mellitus before.
AST (GOT) exceeding 100 IU/L or ALT (GPT) exceeding 100 IU/L.
Creatinine exceeding 2 mg/dl.
Patients with a history of ileus or less than 6 months since celiotomy.
Pregnant women or those who plan to become pregnant, or are in the lactation period.
Habitual drinker (more than 100 ml/day of alcohol).
Patients with a history of gastrectomy.
Patients for whom it is impossible to follow up for 5 years.
Any other reason that the clinical supervisors or clinical researchers may have for considering a case unsuitable for the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Koichi Tamita, MD.
Organizational Affiliation
Division of Cardiology, Kobe General Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Minako Katayama, MD
Organizational Affiliation
Division of Clinical Research Promotion, Institute of Biomedical Research and Innovation.
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Yutaka Furukawa, MD
Organizational Affiliation
Division of Cardiology, Kobe General Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Institute of Biomedical Research and Innovation.
City
Kobe
State/Province
Hyogo Pref.
ZIP/Postal Code
650-0047
Country
Japan
Facility Name
Kobe City General Hospital/Institute of Biomedical Research and Innovation
City
Kobe
State/Province
Hyogo Pref.
ZIP/Postal Code
650-0047
Country
Japan
Facility Name
Kawasaki Medical School Hospital
City
Kurashiki
State/Province
Okayama
ZIP/Postal Code
701-0192
Country
Japan
12. IPD Sharing Statement
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Acarbose and Secondary Prevention After Coronary Stenting
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