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

NCT ID: NCT00212017

Last Updated: 2018-08-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

3000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-04-30

Study Completion Date

2017-08-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Impaired Glucose Tolerance Myocardial Infarction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Prospective, randomised, open, blinded-endpoint study
Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors
This is an open and blinded-endpoint study

Study Groups

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the voglibose group

Participants in the voglibose group were administered a voglibose tablet (0.2 mg) three times daily before meals.

Group Type ACTIVE_COMPARATOR

voglibose

Intervention Type DRUG

the control group

Participants assigned to the control group were treated only with diet and exercise therapy.

Group Type ACTIVE_COMPARATOR

diet and exercise therapy

Intervention Type BEHAVIORAL

Interventions

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voglibose

Intervention Type DRUG

diet and exercise therapy

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ministry of Health, Labor and Welfare (Japan)

UNKNOWN

Sponsor Role collaborator

National Cerebral and Cardiovascular Center, Japan

OTHER

Sponsor Role lead

Responsible Party

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Masafumi Kitakaze

Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Masafumi Kitakaze, MD, PhD

Role: STUDY_CHAIR

National Cerebral and Cardiovascular Center, Japan

Locations

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National Cardiovascular Center

Suita, Osaka, Japan

Site Status

Countries

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Japan

References

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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.

Reference Type RESULT
PMID: 28779371 (View on PubMed)

Other Identifiers

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UMIN_ID:C000000090

Identifier Type: -

Identifier Source: secondary_id

CSSCJ-3

Identifier Type: -

Identifier Source: org_study_id

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