Clinical trial NCT00221156: Acarbose and Secondary Prevention After Coronary Stenting
Official title: Effects of Acarbose Long-Term Therapy on Prevention of Cardiovascular Events in Abnormal Glucose Tolerance With Coronary Artery Disease (ALERT Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Glucose Metabolism Disorders
Coronary Artery Disease
Keywords: Abnormal Glucose Tolerance
coronary artery disease
diabetes mellitus
clinical outcome
Lead sponsor: Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
Sponsor class: OTHER
Collaborators: name: Institute of Biomedical Research and Innovation, Kobe, Hyogo, Japan
name: Kobe City General Hospital
First posted: 2005-09-22
Enrollment: 300
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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. 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 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.

Primary outcomes:
measure: Cardiovascular event free survival time
Secondary outcomes:
measure: Conversion of abnormal glucose tolerance to type 2 diabetes
measure: All causes of death
measure: Occurrence of every cardiovascular event
measure: Occurrence of in-stent restenosis
measure: Change in fasting, 2-hour blood glucose and insulin level
measure: Change in homeostasis model assessment of insulin resistance
measure: Change in hemoglobin A1c (HbA1c)
measure: Change in lipid profile
Other outcomes:
Locations:
city: Kobe
country: Japan
facility: Institute of Biomedical Research and Innovation.
state: Hyogo Pref.
city: Kobe
country: Japan
facility: Kobe City General Hospital/Institute of Biomedical Research and Innovation
state: Hyogo Pref.
city: Kurashiki
country: Japan
facility: Kawasaki Medical School Hospital
state: Okayama
Study officials:
affiliation: Division of Cardiology, Kobe General Hospital
name: Koichi Tamita, MD.
role: PRINCIPAL_INVESTIGATOR
affiliation: Division of Clinical Research Promotion, Institute of Biomedical Research and Innovation.
name: Minako Katayama, MD
role: STUDY_DIRECTOR
affiliation: Division of Cardiology, Kobe General Hospital
name: Yutaka Furukawa, MD
role: STUDY_DIRECTOR
References: