Assessment of an Alpha-glucosidase Inhibitor to Block Cardiac Events in Patients With MI and IGT

Myocardial Infarction Clinical Trial

Official title:

The Japan Working Group for the Assessment That the Alpha-glucosidase Inhibitor Blocks Cardiac Events in Patients With Myocardial Infarction and IGT

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00212017
• Other study ID #: CSSCJ-3
• Secondary ID: UMIN_ID:C0000000
• Status: Terminated
• Phase: N/A
• Start date: April 2005
• Est. completion date: August 2017

Study information

• Verified date: August 2018
• Source: National Cerebral and Cardiovascular Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate whether an alpha-glucosidase inhibitor, a drug for the suppression of postprandial hyperglycemia, could reduce the recurrence of myocardial infarction in patients with impaired glucose tolerance (IGT) and old myocardial infarction.

Description:

Type 2 diabetes mellitus is a well-established risk factor for coronary heart disease and atherosclerotic change in the coronary artery develops subclinically in a state of impaired glucose tolerance (IGT). Recently postprandial hyperglycemia as a feature of impaired glucose tolerance is recognized as a significant risk factor for coronary heart disease. So we designed a prospective randomized multi-center trial named Assessment of an α-glucosidase-inhibitor to Block Cardiac Events in Patients With Myocardial Infarction and IGT (ABC study) to evaluate whether an α-Glucosidase Inhibitor, a drug for the suppression of postprandial hyperglycemia, could reduce the recurrence of myocardial infarction in patients with IGT and old myocardial infarction.

100 hospitals will participate in the ABC study. Patients with IGT who have a history of prior myocardial infarction are randomly allocated to receive α-Glucosidase Inhibitor (voglibose) or a standard diet and exercise treatment. The number of patients to be recruited is 3000 and this study will continue for at least 2 years. The primary end-points are:

1. cardiovascular mortality and

2. hospitalization for cardiovascular events.

Effects in suppression of new diabetes development will also be evaluated.

We should recognize IGT as an important therapeutic target to decrease the recurrence of cardiovascular events. The ABC study, a large scale multi-center trial in Japan, will provide us with new evidence on how to treat IGT patients with prior myocardial infarction.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3000
• Est. completion date: August 2017
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

1. Impaired glucose tolerance

2. History of myocardial infarction

Exclusion Criteria:

1. Type I diabetes

2. History of coronary artery bypass graft

3. Severe liver and/or kidney dysfunction

4. History of allergic response to drugs

5. Arteriosclerosis obliterans

Related Conditions & MeSH terms

• Glucose Intolerance
• Impaired Glucose Tolerance
• Infarction
• Myocardial Infarction

Intervention

Drug:
• voglibose

Behavioral:
• diet and exercise therapy

Locations

Country	Name	City	State
Japan	National Cardiovascular Center	Suita	Osaka

Sponsors (2)

Lead Sponsor	Collaborator
National Cerebral and Cardiovascular Center	Ministry of Health, Labor and Welfare (Japan)

Country where clinical trial is conducted

Japan, 

References & Publications (1)

Asakura M, Kim J, Asanuma H, Hamasaki T, Tsukahara K, Higashino Y, Ishikawa T, Nakama Y, Koba S, Maruyama Y, Tsujimoto M, Himeno H, Ohkusa T, Fujino S, Shimizu M, Endo T, Yoda S, Muroya T, Murohara T, Ohte N, Suzuki H, Kohno T, Fukui K, Shiono T, Takase H — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the time till the first cardiovascular composite endpoint of death from cardiovascular death, and hospitalization due to nonfatal myocardial infarction, nonfatal unstable angina[16], nonfatal stroke, or treatment with coronary revascularisation	the time till the first cardiovascular composite endpoint of death from the time till the first cardiovascular composite endpoint of death from cardiovascular death, and hospitalization due to nonfatal myocardial infarction, nonfatal unstable angina[16], nonfatal stroke, or treatment with coronary revascularisation	May 2005 and June 2012
Secondary	All cause mortality	All cause death	May 2005 and June 2012
Secondary	Hospitalization due to coronary artery disease	Hospitalization due to coronary artery disease	May 2005 and June 2012
Secondary	Progression of IGT to diabetes	Progression of IGT to diabetes	May 2005 and June 2012
Secondary	Development or deterioration of either hypertension or hyperlipidemia	Development or deterioration of either hypertension or hyperlipidemia	May 2005 and June 2012
Secondary	Deterioration of renal function	Deterioration of renal function	May 2005 and June 2012
Secondary	Hospitalization due to cerebrovascular disease	Hospitalization due to cerebrovascular disease	May 2005 and June 2012
Secondary	Hospitalization due to heart failure	Hospitalization due to heart failure	May 2005 and June 2012