UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001155 |
|---|---|
| Receipt number | R000000900 |
| Scientific Title | OUtcome of Cypher stent with patients on Hemodialysis registry |
| Date of disclosure of the study information | 2008/05/14 |
| Last modified on | 2016/02/25 17:08:00 |
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Basic information
Public title
OUtcome of Cypher stent with patients on Hemodialysis registry
Acronym
OUCH registry
Scientific Title
OUtcome of Cypher stent with patients on Hemodialysis registry
Scientific Title:Acronym
OUCH registry
Region
| Japan |
Condition
Condition
Hemodialysis patients who undergo elective percutaneous coronary intervention (PCI) using sirolimus eluting stents
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify prognosis and target vessel faiilure in hemodialysis patients undergoing elective PCI with sirolimus elultint stents
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
Target vessel failure (TVF) including cardiac death, myocardial infarction in the target vessel and target vessel revascularization.
Key secondary outcomes
Binary restenosis rate and late loss.
Mortality and major adverse cardiac event rates at 12 months.
Intimal hyperplasia measured by IVUS.
Relation between dialysis membrane and MACE or lat loss.
Relation between alpha 2 macroglobulin and late lumen loss.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Percutaneous coronary intervention (PCI) using sirolimus eluting stents
Interventions/Control_2
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
| 21 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Chronic hemodialysis patients.
Elective PCI using sirolimus eluting stents.
Key exclusion criteria
Peritoneal dialysis.
Cardiac arrest or survivor of sudden death.
Cardiac shock.
Emergent PCI.
ST elevation myocardial infarction.
Impossible to use antiplatelet drugs.
Coronary stent implantation within 6 months.
In stent restenosis lesion wihin drug eluting stents.
Severe valvular disease.
Critical limb ischemia.
Chronic total occlusion as a target vessel.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yuji Ikari, MD, PhD |
Organization
Tokai University School of Medicine
Division name
Cardiology
Zip code
Address
143 Shimokasuya, Isehara, Kanagawa
TEL
0463-93-1121
ikari@is.icc.u-tokai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuji Ikari |
Organization
Tokai University
Division name
Cardiology
Zip code
Address
143 Shimokasuya, Isehara 259-1193
TEL
0463-93-1121
Homepage URL
ikari@is.icc.u-tokai.ac.jp
Sponsor or person
Institute
CITE group
Institute
Department
Personal name
Funding Source
Organization
Johnson & Johnson
Organization
Division
Category of Funding Organization
Outside Japan
Nationality of Funding Organization
USA
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
| 2008 | Year | 05 | Month | 14 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://www.ncbi.nlm.nih.gov/pubmed/26219496
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 | 06 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2010 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
| 2010 | Year | 03 | Month | 01 | Day |
Date analysis concluded
| 2010 | Year | 03 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2008 | Year | 05 | Month | 13 | Day |
Last modified on
| 2016 | Year | 02 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000900
