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

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 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


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

Value
https://center6.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