Acarbose and Secondary Prevention After Coronary Stenting

This study has been completed.
Sponsor:
Collaborators:
Institute of Biomedical Research and Innovation, Kobe,Hyogo, Japan
Kobe City General Hospital
Information provided by:
Translational Research Informatics Center, Kobe, Hyogo, Japan
ClinicalTrials.gov Identifier:
NCT00221156
First received: September 13, 2005
Last updated: June 23, 2009
Last verified: June 2009

September 13, 2005
June 23, 2009
May 2005
Not Provided
Cardiovascular event free survival time
Same as current
Complete list of historical versions of study NCT00221156 on ClinicalTrials.gov Archive Site
  • 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
  • ・Conversion of abnormal glucose tolerance to type 2 diabetes
  • ・All cause of death
  • ・Occurrence of every cardio cascular event
  • ・Occurrence of in-stent restenosis
  • ・Regression of intimal plus medial complex of the carotid artery
  • ・Change in fasting, 2-hour blood glucose and insulin level
  • ・Change in homeostatis model assessment of insulin residtance
  • ・Change in HbA1c
  • ・Change in lipid profile
Not Provided
Not Provided
 
Acarbose and Secondary Prevention After Coronary Stenting
Effects of Acarbose Long-Term Therapy on Prevention of Cardiovascular Events in Abnormal Glucose Tolerance With Coronary Artery Disease (ALERT Study)

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Glucose Metabolism Disorders
  • Coronary Artery Disease
Drug: Acarbose
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
300
April 2009
Not Provided

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.
Both
20 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00221156
BRI_CAD_04-02
Not Provided
Not Provided
Translational Research Informatics Center, Kobe, Hyogo, Japan
  • Institute of Biomedical Research and Innovation, Kobe,Hyogo, Japan
  • Kobe City General Hospital
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
Translational Research Informatics Center, Kobe, Hyogo, Japan
June 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP