UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002307 |
|---|---|
| Receipt number | R000001078 |
| Scientific Title | Effects of granulocyte colony stimulating factor on endothelial dysfunction after implanting drug-eluting stents. |
| Date of disclosure of the study information | 2009/08/10 |
| Last modified on | 2013/02/13 19:54:45 |
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Basic information
Public title
Effects of granulocyte colony stimulating factor on endothelial dysfunction after implanting drug-eluting stents.
Acronym
Effects of GCSF after implanting DES.
Scientific Title
Effects of granulocyte colony stimulating factor on endothelial dysfunction after implanting drug-eluting stents.
Scientific Title:Acronym
Effects of GCSF after implanting DES.
Region
| Japan |
Condition
Condition
ischemic heart disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of granulocyte colony stimulating factor on accelarating reendotheliazation after implanting drug-eluting coronary stents.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Difference in recovery of endothelium dependent relaxation between GCSF group and non-GCSF group
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
GCSF
Interventions/Control_2
Saline
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
All adult patients undergoing percutaneous coronary intervention which sirolimus-eluting stent is implanted
Key exclusion criteria
Acute myocardial infarction, revascularization of in stent restenosis,
any other contraindication of DES use
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yo Iwata |
Organization
Chiba University Graduate School of Medicine
Division name
Department of Cardiovasvular Science and Medicine
Zip code
Address
1-8-1 Inohana, Chuo-ku, Chiba, Chiba, Japan
TEL
043-226-2340
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshio Kobayashi |
Organization
Chiba University Graduate School of Medicine
Division name
1-8-1 Inohana, Chuo-ku, Chiba, Chiba, Japan
Zip code
Address
TEL
043-226-2340
Homepage URL
Sponsor or person
Institute
Chiba University Graduate School of Medicine Department of Cardiovascular Science and Medicine
Institute
Department
Personal name
Funding Source
Organization
Kyowa Hakko Kirin, Ltd
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
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
千葉大学病院 （千葉県）
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 08 | Month | 10 | 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
Completed
Date of protocol fixation
| 2007 | Year | 10 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 02 | 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
| 2009 | Year | 08 | Month | 07 | Day |
Last modified on
| 2013 | Year | 02 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001078
