Acarbose and Secondary Prevention After Coronary Stenting

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00221156
• Other study ID #: BRI_CAD_04-02
• Status: Completed
• Phase: Phase 3
• First received: September 13, 2005
• Last updated: June 23, 2009
• Start date: May 2005
• Est. completion date: April 2009

Study information

• Verified date: June 2009
• Source: Translational Research Informatics Center, Kobe, Hyogo, Japan
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and WelfareJapan: Ministry of Education, Culture, Sports, Science and Technology
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Glucose Metabolism Disorders
• Metabolic Diseases
• Myocardial Ischemia

Intervention

Drug:
• Acarbose

Locations

Country	Name	City	State
Japan	Institute of Biomedical Research and Innovation.	Kobe	Hyogo Pref.
Japan	Kobe City General Hospital/Institute of Biomedical Research and Innovation	Kobe	Hyogo Pref.
Japan	Kawasaki Medical School Hospital	Kurashiki	Okayama

Sponsors (3)

Lead Sponsor	Collaborator
Translational Research Informatics Center, Kobe, Hyogo, Japan	Institute of Biomedical Research and Innovation, Kobe,Hyogo, Japan, Kobe City General Hospital

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiovascular event free survival time
Secondary	Conversion of abnormal glucose tolerance to type 2 diabetes
Secondary	All causes of death
Secondary	Occurrence of every cardiovascular event
Secondary	Occurrence of in-stent restenosis
Secondary	Change in fasting, 2-hour blood glucose and insulin level
Secondary	Change in homeostasis model assessment of insulin resistance
Secondary	Change in hemoglobin A1c (HbA1c)
Secondary	Change in lipid profile