UMIN-CTR Clinical Trial

Basic information
Public title	Acarbose for Secondary Prevention of Cardiovascular Events in Patients With Coronary Stenting and Abnormal Glucose Tolerance
Acronym	Acarbose and Secondary Prevention after Coronary Stenting
Scientific Title	Acarbose for Secondary Prevention of Cardiovascular Events in Patients With Coronary Stenting and Abnormal Glucose Tolerance
Scientific Title:Acronym	Acarbose and Secondary Prevention after Coronary Stenting
Region	Japan

Condition
Condition	Abnormal Glucose Tolerance
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to determine whether the intervention to newly diagnosed abnormal glucose tolerance after coronary stenting will improve the long-term clinical outcome.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase III

Assessment
Primary outcomes	Cardiovascular event free survival time
Key secondary outcomes	1)Conversion of abnormal glucose tolerance to type 2 diabetes 2)All cause of death 3)Occurrence of every cardiovascular event 4)Occurrence of in-stent restenosis 5)Regression of intimal plus medial complex of the carotid artery 6)Change in fasting, 2-hour blood glucose and insulin level 7)Change in homeostatis model assessment of insulin resistance 8)Change in HbA1c 9)Change in lipid profile 10)Change in high sensitive CRP 11)Change in Body Mass Index and body weight

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	YES
Dynamic allocation	YES
Institution consideration	Institution is considered as adjustment factor in dynamic allocation.
Blocking
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Medicine Behavior,custom
Interventions/Control_1	Acarbose with a standard lifestyle modification for five years
Interventions/Control_2	A standard lifestyle modification for five years
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	75 years-old >
Gender	Male and Female
Key inclusion criteria	1)Within 8 weeks since implantation of coronary artery stents for stable angina pectoris or acute coronary syndrome. 2)Abnormal Glucose Tolerance according to 75gOGTT. 3)HbA1c is less than 6.5%. 4)Age is between 20 and 75 (at time of consent). 5)Patients who can give informed consent themselves in writing.
Key exclusion criteria	1)Patients with abnormal glucose tolerance caused by other organic disorders such as pancreatitis, hemochromatosis, post pancreatectomy, hyperthyroidism, Cushing syndrome, Prader-Willi syndrome etc. 2)Patients with planned angioplasty. 3)Patients with uncontrollable congestive heart failure. 4)Less than 6 months since last episode of cerebral infarction. 5)Patients who have received medication for diabetes mellitus before. 6)AST(GOT) exceeding 100 IU/L or ALT(GPT) exceeding 100 IU/L. 7)Creatinine exceeding 2mg/dl. 8)Patients with a history of ileus or less than 6 months since celiotomy. 9)Pregnant women or those who plan pregnancy, or are in the lactation period. 10)Habitual drinker (more than 100ml/day of alcohol). 11)Patients with a history of gastrectomy. 12)Patients for whom it is impossible to follow up for 5 years. 13)Any other reason that the clinical supervisors or clinical researchers may have for considering a case unsuitable for the study.
Target sample size	300

Research contact person
Name of lead principal investigator	1st name Middle name Last name Koichi Tamita
Organization	Kobe City General Hospital
Division name	Division of Cardiology
Zip code
Address	4-6,Minatojima Nakamachi Chuoku, Kobe, Japan
TEL	078-302-4321
Email

Public contact
Name of contact person	1st name Middle name Last name Minako Katayama
Organization	Institute of Biomedical Research and Innovation
Division name	Department of Clinical Research Promotion
Zip code
Address	2-2, Minatojima Minamimachi Chuoku, Kobe, Japan
TEL	078-304-5200
Homepage URL
Email	minako.wk@gmail.com

Sponsor
Institute	Institute of Biomedical Research and Innovation
Institute
Department

Funding Source
Organization	Institute of Biomedical Research and Innovation
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	Translational Research Informatics Center
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs	YES
Study ID_1	BRI_CAD_04-02
Org. issuing International ID_1	Translational Research Informatics Center
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 09 Month 13 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
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	No longer recruiting
Date of protocol fixation	2005 Year 04 Month 13 Day
Date of IRB
Anticipated trial start date	2005 Year 05 Month 01 Day
Last follow-up date	2013 Year 04 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2005 Year 09 Month 08 Day
Last modified on	2009 Year 03 Month 31 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000203

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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