UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000790 |
|---|---|
| Receipt number | R000000949 |
| Scientific Title | The Heart Institute of Japan Candesartan Randomized trial for Evaluation in Coronary Artery Disease |
| Date of disclosure of the study information | 2007/11/07 |
| Last modified on | 2007/11/05 08:09:04 |
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Basic information
Public title
The Heart Institute of Japan Candesartan Randomized trial for Evaluation in Coronary Artery Disease
Acronym
HIJ-CREATE
Scientific Title
The Heart Institute of Japan Candesartan Randomized trial for Evaluation in Coronary Artery Disease
Scientific Title:Acronym
HIJ-CREATE
Region
| Japan |
Condition
Condition
Coronary artery disease
Classification by specialty
| Medicine in general | Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the effects of candesartan-based pharmacotherapy on major cadiovascular adverse events in coronary artery disease patients with hypertension with those of non-ARB standard pharmacotherapy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The primary endpoint of the present study was the time to the first major adverse cardiovascular events.
Key secondary outcomes
The major secondary endpoints included the incidence of coronary revascularization and new-onset diabetes.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
Candesartan-based therapy without any angiotensin-converting enzyme inhibitors
Interventions/Control_2
Non-ARB based standard therapy
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Coronary angiographically documented patients with coronary artery disease and hypertension
Key exclusion criteria
Patients with
socondary hypertension
hypertrophic obstructive cardiomyopathy
Acute myocardial infarction (withih 7 days)
cerebrovascular disease within 3 months
serum Creatinine >=2.0mg/dl
hyperkalemia
Target sample size
2030
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroshi Kasanuki |
Organization
The Heart Institute of Japan, Tokyo Women's Medical University
Division name
Cardiology
Zip code
Address
8-1 Kawada-cho, Shinjuku-ku, Tokyo 162-8666, Japan
TEL
03-3353-8111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroshi Ogawa |
Organization
The Heart Institute of Japan, Tokyo Women's Medical University
Division name
Cardiology
Zip code
Address
8-1 Kawada-cho, Shinjuku-ku, Tokyo 162-8666, Japan
TEL
03-3353-8111
Homepage URL
http://hijc.gr.jp/
mogawa@hij.twmu.ac.jp
Sponsor or person
Institute
HIJC Study group
Institute
Department
Personal name
Funding Source
Organization
The Japan Research Promotion Society for
Cardiovascular Diseases, Tokyo, Japan.
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2007 | Year | 11 | Month | 07 | Day |
Related information
URL releasing protocol
http://hijc.gr.jp/
Publication of results
Unpublished
Result
URL related to results and publications
http://hijc.gr.jp/
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
Completed
Date of protocol fixation
| 2001 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2001 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2007 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
| 2007 | Year | 10 | Month | 01 | Day |
Date trial data considered complete
| 2007 | Year | 10 | Month | 01 | Day |
Date analysis concluded
| 2007 | Year | 10 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2007 | Year | 08 | Month | 07 | Day |
Last modified on
| 2007 | Year | 11 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000949
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
