Acarbose and Secondary Prevention After Coronary Stenting

Sponsor

Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan (Other)

Overall Status

Completed

CT.gov ID

NCT00221156

Collaborator

Institute of Biomedical Research and Innovation, Kobe, Hyogo, Japan (Other), Kobe City General Hospital (Other)

300

Enrollment

Locations

Duration (Months)

100

Patients Per Site

2.1

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Glucose Metabolism Disorders Coronary Artery Disease	Drug: Acarbose	Phase 3

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

300 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Effects of Acarbose Long-Term Therapy on Prevention of Cardiovascular Events in Abnormal Glucose Tolerance With Coronary Artery Disease (ALERT Study)

Study Start Date :

May 1, 2005

Actual Study Completion Date :

Apr 1, 2009

Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Institute of Biomedical Research and Innovation.	Kobe	Hyogo Pref.	Japan	650-0047
2	Kobe City General Hospital/Institute of Biomedical Research and Innovation	Kobe	Hyogo Pref.	Japan	650-0047
3	Kawasaki Medical School Hospital	Kurashiki	Okayama	Japan	701-0192

Sponsors and Collaborators

Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
Institute of Biomedical Research and Innovation, Kobe, Hyogo, Japan
Kobe City General Hospital

Investigators

Principal Investigator: Koichi Tamita, MD., Division of Cardiology, Kobe General Hospital
Study Director: Minako Katayama, MD, Division of Clinical Research Promotion, Institute of Biomedical Research and Innovation.
Study Director: Yutaka Furukawa, MD, Division of Cardiology, Kobe General Hospital