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Completed

NCT Number: NCT00221156

Acarbose and Secondary Prevention After Coronary Stenting

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.

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Key information

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Institute of Biomedical Research and Innovation., Kobe, Hyogo Pref., Japan

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Acarbose

Drug

Primary outcomes

  1. Cardiovascular event free survival time

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan

Other

Collaborators

  • Institute of Biomedical Research and Innovation, Kobe, Hyogo, Japan
  • Kobe City General Hospital

Registry information

Official study title

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

Important dates

Study start
2005
Study completion
2009
First posted
Sep 22, 2005
Registry last updated
Jun 25, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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