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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000004177
Receipt No. 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

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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
Email

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
Email k0301crm@wakayama-med.ac.jp

Sponsor
Institute Division of Cardiovascular Medicine, Wakayama Medical University
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005016

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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