Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Acarbose and Secondary Prevention After Coronary Stenting

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00221156
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : June 25, 2009
Sponsor:
Collaborators:
Institute of Biomedical Research and Innovation, Kobe, Hyogo, Japan
Kobe City General Hospital
Information provided by:
Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated 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 2005
Actual Study Completion Date : April 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Acarbose

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Cardiovascular event free survival time

Secondary Outcome Measures :
  1. Conversion of abnormal glucose tolerance to type 2 diabetes
  2. All causes of death
  3. Occurrence of every cardiovascular event
  4. Occurrence of in-stent restenosis
  5. Change in fasting, 2-hour blood glucose and insulin level
  6. Change in homeostasis model assessment of insulin resistance
  7. Change in hemoglobin A1c (HbA1c)
  8. Change in lipid profile

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00221156


Locations
Layout table for location information
Japan
Institute of Biomedical Research and Innovation.
Kobe, Hyogo Pref., Japan, 650-0047
Kobe City General Hospital/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 Center for Medical Innovation, Kobe, Hyogo, Japan
Institute of Biomedical Research and Innovation, Kobe, Hyogo, Japan
Kobe City General Hospital
Investigators
Layout table for investigator information
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
ClinicalTrials.gov Identifier: NCT00221156    
Other Study ID Numbers: BRI_CAD_04-02
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: June 25, 2009
Last Verified: June 2009
Keywords provided by Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan:
Abnormal Glucose Tolerance
coronary artery disease
diabetes mellitus
clinical outcome
Additional relevant MeSH terms:
Layout table for MeSH terms
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Metabolic Diseases
Glucose Metabolism Disorders
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
 Arterial Occlusive Diseases
Vascular Diseases
Acarbose
Glycoside Hydrolase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents
Physiological Effects of Drugs