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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001155
Receipt No. 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

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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
Email 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
Email ikari@is.icc.u-tokai.ac.jp

Sponsor
Institute CITE group
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000900

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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