UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000140 |
|---|---|
| Receipt number | R000000203 |
| Scientific Title | Acarbose for Secondary Prevention of Cardiovascular Events in Patients With Coronary Stenting and Abnormal Glucose Tolerance |
| Date of disclosure of the study information | 2005/09/13 |
| Last modified on | 2009/03/31 17:54:59 |
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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
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
minako.wk@gmail.com
Sponsor or person
Institute
Institute of Biomedical Research and Innovation
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000203
