UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004177 |
|---|---|
| Receipt number | R000005016 |
| Scientific Title | Randomized Evaluation of Paclitaxel-eluting versus Everolimus-eluting stent Trial |
| Date of disclosure of the study information | 2010/09/08 |
| Last modified on | 2010/09/08 17:01:47 |
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Basic information
Public title
Randomized Evaluation of Paclitaxel-eluting versus Everolimus-eluting stent Trial
Acronym
Rapeet study
Scientific Title
Randomized Evaluation of Paclitaxel-eluting versus Everolimus-eluting stent Trial
Scientific Title:Acronym
Rapeet study
Region
| Japan |
Condition
Condition
coronary artery disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Comparision of efficacy and safety of paclitaxel-eluting and everolimus-eluting stent
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Taget vessel revascularization
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Paclitaxel-eluting stent
Interventions/Control_2
Evalorimus-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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Undergoing of drug-eluting stent implantation
Key exclusion criteria
No candiated for drug-eluing stent implantation
Target sample size
800
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takashi Akasaka |
Organization
Wakayama Medical University
Division name
Division of Cardiovascular Medicine
Zip code
Address
811-1, Kimiidera, Wakayama
TEL
073-447-2300
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Keizo Kimura |
Organization
Wakayama Medical University
Division name
Division of Cardiovascular Medicine
Zip code
Address
TEL
Homepage URL
k0301crm@wakayama-med.ac.jp
Sponsor or person
Institute
Division of Cardiovascular Medicine, Wakayama Medical University
Institute
Department
Personal name
Funding Source
Organization
Division of Cardiovascular Medicine, Wakayama Medical University
Organization
Division
Category of Funding Organization
Other
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
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 09 | Month | 08 | 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
Enrolling by invitation
Date of protocol fixation
| 2010 | Year | 09 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 08 | Month | 01 | Day |
Date of closure to data entry
| 2016 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 09 | Month | 08 | Day |
Last modified on
| 2010 | Year | 09 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005016
