UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010933 |
|---|---|
| Receipt number | R000012773 |
| Scientific Title | Mie multicenter registry of hemodialysis patients undergoing PCI with drug-eluting stent |
| Date of disclosure of the study information | 2013/06/11 |
| Last modified on | 2015/12/11 16:00:00 |
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Basic information
Public title
Mie multicenter registry of hemodialysis patients undergoing PCI with drug-eluting stent
Acronym
MY HOPE Study
Scientific Title
Mie multicenter registry of hemodialysis patients undergoing PCI with drug-eluting stent
Scientific Title:Acronym
MY HOPE Study
Region
| Japan |
Condition
Condition
coronary artery disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to investigate the midterm outcomes of everolimus-eluting stent or paclitaxel-eluting stent for hemodialysis patients with coronary artery disease
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
the rate of binary restenosis
Key secondary outcomes
the rate of major adverse cardiac events
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
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Percutaneous coronary intervention using everolimus-eluting stent
Interventions/Control_2
Percutaneous coronary intervention using paclitaxel-eluting stent
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. hemodialysis patients
2. patients who are indicated for PCI with drug-eluting stents
3. patients who can recieve antiplatelet agents for at least 6 months after stent implantation
4. target lesion with the vessel 2.5-3.75mm in diameter
5. target lesion with the vessel < 46mm in length
Key exclusion criteria
1. patients with acute myocardial infarction within 7 days
2. patients with neoplasm within 3 years
3. patients who are enrolled in an ongoing registry or clinical trial
4. patients with PCI within 6 months
5. patients who have chronic total occlusion
6. patients who have bifurcation lesion
7. patients who have restenotic lesion
8. patients who have lesion of bypass graft
9. nursing women or pregnant possible women
10. patients who have an allergy or hypersensitivity to everolimus and paclitaxel
11. patients who have side effects of antiplatelet agents or anticoaglants
12. patients who have severe liver dysfunction
13. patients disqualified from participation by the investigator
Target sample size
180
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masatoshi Miyahara |
Organization
Mie Heart Center
Division name
Department of Cardiology
Zip code
Address
Meiwa-cho, Taki-Gun, Mie
TEL
0596-55-8188
miyahara@mie-heartcenter.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masatoshi Miyahara |
Organization
Mie Heart Center
Division name
Department of Cardiology
Zip code
Address
Meiwa-cho, Taki-Gun, Mie
TEL
0596-55-8188
Homepage URL
miyahara@mie-heartcenter.com
Sponsor or person
Institute
MY HOPE Project Office
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
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
岡波総合病院
尾鷲総合病院
鈴鹿中央総合病院
名張市立病院
松阪中央総合病院
三重県立総合医療センター
三重大学医学部附属病院
三重ハートセンター
伊勢赤十字病院
山本総合病院
四日市社会保険病院
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 06 | Month | 11 | 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
Terminated
Date of protocol fixation
| 2012 | Year | 05 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 05 | Month | 28 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 06 | Month | 11 | Day |
Last modified on
| 2015 | Year | 12 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012773
