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
  Purpose

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 Intervention Phase
Glucose Metabolism Disorders
Coronary Artery Disease
Drug: Acarbose
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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)

Resource links provided by NLM:


Further study details as provided by Translational Research Informatics Center, Kobe, Hyogo, Japan:

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

Estimated Enrollment: 300
Study Start Date: May 2005
Study Completion Date: April 2009
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.

  Eligibility

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00221156

Locations
Japan
Kobe City General Hospital/Institute of Biomedical Research and Innovation
Kobe, Hyogo Pref., Japan, 650-0047
Institute of Biomedical Research and Innovation.
Kobe, Hyogo Pref., Japan, 650-0047
Kawasaki Medical School Hospital
Kurashiki, Okayama, Japan, 701-0192
Sponsors and Collaborators
Translational Research Informatics Center, 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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00221156     History of Changes
Other Study ID Numbers: BRI_CAD_04-02
Study First Received: September 13, 2005
Last Updated: June 23, 2009
Health Authority: Japan: Ministry of Health, Labor and Welfare
Japan: Ministry of Education, Culture, Sports, Science and Technology

Keywords provided by Translational Research Informatics Center, Kobe, Hyogo, Japan:
Abnormal Glucose Tolerance
coronary artery disease
diabetes mellitus
clinical outcome

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Glucose Metabolism Disorders
Metabolic Diseases
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Acarbose
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 19, 2014