Status:
COMPLETED
Acarbose and Secondary Prevention After Coronary Stenting
Lead Sponsor:
Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
Collaborating Sponsors:
Institute of Biomedical Research and Innovation, Kobe, Hyogo, Japan
Kobe City General Hospital
Conditions:
Glucose Metabolism Disorders
Coronary Artery Disease
Eligibility:
All Genders
20-75 years
Phase:
PHASE3
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. Seve...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2009
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT00221156
Start Date
May 1 2005
End Date
April 1 2009
Last Update
June 25 2009
Active Locations (3)
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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-ken, Japan, 701-0192