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

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

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.

Study Overview

• Status: Terminated
• Conditions: Myocardial Infarction; Impaired Glucose Tolerance
• Intervention / Treatment: Drug: voglibose; Behavioral: diet and exercise therapy

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 3000
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Japan
  • Osaka
    • Suita, Osaka, Japan, 565-8565
      • National Cardiovascular Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: the voglibose group; Participants in the voglibose group were administered a voglibose tablet (0.2 mg) three times daily before meals.	Drug: voglibose
Active Comparator: the control group; Participants assigned to the control group were treated only with diet and exercise therapy.	Behavioral: diet and exercise therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
All cause mortality	All cause death	May 2005 and June 2012
Hospitalization due to coronary artery disease	Hospitalization due to coronary artery disease	May 2005 and June 2012
Progression of IGT to diabetes	Progression of IGT to diabetes	May 2005 and June 2012
Development or deterioration of either hypertension or hyperlipidemia	Development or deterioration of either hypertension or hyperlipidemia	May 2005 and June 2012
Deterioration of renal function	Deterioration of renal function	May 2005 and June 2012
Hospitalization due to cerebrovascular disease	Hospitalization due to cerebrovascular disease	May 2005 and June 2012
Hospitalization due to heart failure	Hospitalization due to heart failure	May 2005 and June 2012

Collaborators and Investigators

• Sponsor: National Cerebral and Cardiovascular Center
• Collaborators: Ministry of Health, Labor and Welfare (Japan)

Publications and helpful links

General Publications

• 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, Uzui H, Nagai Y, Hashimoto Y, Ikeda S, Mizuno S, Tamita K, Fujita M, Satake K, Kinoshita Y, Nunohiro T, Sakagami S, Higaki J, Morii I, Sawada R, Hiasa Y, Shigemasa T, Nakahama M, Sata M, Doi O, Ueda T, Yamada T, Yamanouchi T, Yamaguchi H, Morita Y, Hayashi H, Kitakaze M; ABC investigators. Does Treatment of Impaired Glucose Tolerance Improve Cardiovascular Outcomes in Patients with Previous Myocardial Infarction? Cardiovasc Drugs Ther. 2017 Aug;31(4):401-411. doi: 10.1007/s10557-017-6740-3.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2005
• Primary Completion (Actual): June 1, 2012
• Study Completion (Actual): August 1, 2017

Study Registration Dates

• First Submitted: September 13, 2005
• First Submitted That Met QC Criteria: September 13, 2005
• First Posted (Estimate): September 21, 2005

Study Record Updates

• Last Update Posted (Actual): August 22, 2018
• Last Update Submitted That Met QC Criteria: August 20, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: Myocardial Infarction; IGT; alpha-glucosidase inhibitor; re-infarction prevention
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Genetic Diseases, Inborn; Carbohydrate Metabolism, Inborn Errors; Metabolism, Inborn Errors; Lysosomal Storage Diseases; Hyperglycemia; Brain Diseases, Metabolic; Brain Diseases, Metabolic, Inborn; Lysosomal Storage Diseases, Nervous System; Glycogen Storage Disease; Myocardial Infarction; Infarction; Glucose Intolerance; Glycogen Storage Disease Type II; Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Glycoside Hydrolase Inhibitors; Voglibose
• Other Study ID Numbers: CSSCJ-3; UMIN_ID:C000000090

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No