UMIN-CTR Clinical Trial

Unique ID issued by UMIN C000000090
Receipt number R000000132
Scientific Title The Japan Working Group for the Assessment That the Alpha-glucosidase-inhibitor Blocks Cardiac Events in Patients With Myocardial Infarction and IGT
Date of disclosure of the study information 2005/08/31
Last modified on 2018/05/22 10:36:01

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Basic information

Public title

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

Acronym

ABC Study

Scientific Title

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

Scientific Title:Acronym

ABC Study

Region

Japan


Condition

Condition

Patients With Myocardial Infarction and IGT

Classification by specialty

Cardiology Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate whether alpha-glucosidase inhibitor, a drug for the supression postprandial hyperglycemia, could reduce the recurrence of myocardial infarction in patients with IGT and old myocardial infarction.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

1.Cardiovascular mortality
2.Hospitalization due to cardiovascular events

Key secondary outcomes

(1) All cause mortality
(2) Hospitalization due to coronary artery disease
(3) Progression of IGT to diabetes
(4) Development or deterioration of either hypertension or hyperlipidemia
(5) Deterioraion of renal function
(6) Hospitalization due to cerebrovascular disease
(7) Hospitalization due to heart failure


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Cluster

Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Medicine

Interventions/Control_1

In the voglibose group, voglibose will be prescribed at 0.6mg three times daily.

Interventions/Control_2

In control group, each participated doctor will instruct patients on a weight reduction or weight maintenance diet, and encouraged them to exercise regularly.

Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit

100 years-old >=

Gender

Male and Female

Key inclusion criteria

1.Impaired Glucose Tolerance
2.History of myocardial infarction

Key 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

Target sample size

1570


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Masafumi Kitakaze

Organization

National Cardiovascular Center

Division name

Cardiovascular Division

Zip code


Address

5-7-1 Fujishirodai, Suita City, Osaka Pref. 565-8565, Japan

TEL

06-6833-5012

Email

kitakaze@zf6.so-net.ne.jp


Public contact

Name of contact person

1st name
Middle name
Last name Masafumi Kitakaze

Organization

Clinical Study Support Center Japan (CSSCJ)

Division name

ABC office

Zip code


Address

5-7-1 Fujishirodai, Suita Osaka 565-8565, JAPAN

TEL

06-6836-5012

Homepage URL

http://www.csscj.com

Email

kitakaze@zf6.so-net.ne.jp


Sponsor or person

Institute

National Cardiovascular Center

Institute

Department

Personal name



Funding Source

Organization

Grants in Health and Labour Sciences Research from the Ministry of Health, Labour and Welfare, Japan.

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2005 Year 08 Month 31 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications

https://www.ncbi.nlm.nih.gov/pubmed/28779371

Number of participants that the trial has enrolled


Results

The age, ratio of males, and HbA1C were 65 vs. 65 years, 86 vs. 87%, and 5.6 vs. 5.5% in the groups with and without voglibose, respectively. Voglibose improved IGT; however, Kaplan-Meier analysis showed no significant between-group difference with respect to cardiovascular events [12.5% with voglibose vs. 10.1% without voglibose for the primary endpoint (95% confidence interval, 0.82-1.86)]; there were no significant differences in secondary endpoints.

Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2004 Year 11 Month 01 Day

Date of IRB


Anticipated trial start date

2005 Year 04 Month 01 Day

Last follow-up date

2012 Year 06 Month 30 Day

Date of closure to data entry

2012 Year 06 Month 30 Day

Date trial data considered complete

2013 Year 06 Month 30 Day

Date analysis concluded

2015 Year 02 Month 28 Day


Other

Other related information



Management information

Registered date

2005 Year 08 Month 29 Day

Last modified on

2018 Year 05 Month 22 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000132


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name