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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN C000000090
Receipt No. 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

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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
Institute National Cardiovascular Center
Institute
Department

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
URL(English) https://upload.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


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