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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000002634
Receipt No. R000002615
Scientific Title Randomized Evaluation of Sirolimus-eluting versus Everolimus-eluting stent Trial (RESET)
Date of disclosure of the study information 2009/11/01
Last modified on 2010/04/16

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Basic information
Public title Randomized Evaluation of Sirolimus-eluting versus Everolimus-eluting stent Trial (RESET)
Acronym RESET
Scientific Title Randomized Evaluation of Sirolimus-eluting versus Everolimus-eluting stent Trial (RESET)
Scientific Title:Acronym RESET
Region
Japan

Condition
Condition coronary artery disease
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy and long-term safety of XIENCE drug-eluting stent
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Any TLR at 1 year
Death / MI at 3 years
Key secondary outcomes Death / MI at 1 year and 2 years
Success rate for stent deployment

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 XIENCE V stent implantation in 1600 patients
Interventions/Control_2 CYPHER SELECT+stent implantation in 1600 patients
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 The patients who will be recieved drug-eluting stent
Key exclusion criteria The patients who refuse to participate in this study
Target sample size 3200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name KIMURA TAKESHI
Organization Kyoto University Hospital
Division name Department of Cardiovascular Medicine
Zip code
Address 606-8507 54 Kawahara-cho Syogoin Sakyo-ku Kyoto City
TEL 075-751-3185
Email

Public contact
Name of contact person
1st name
Middle name
Last name TAMURA TOSHIHIRO
Organization Kyoto University Hospital
Division name Department of Cardiovascular Medicine
Zip code
Address 606-8507 54 Kawahara-cho Syogoin Sakyo-ku Kyoto City
TEL 075-751-4255
Homepage URL
Email ttamu@kuhp.kyoto-u.ac.jp

Sponsor
Institute RESET trial
Institute
Department

Funding Source
Organization Abbott Vascular Japan, Co., Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor nothing
Name of secondary funder(s) nothing

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
2009 Year 11 Month 01 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 Preinitiation
Date of protocol fixation
2009 Year 07 Month 27 Day
Date of IRB
Anticipated trial start date
2010 Year 02 Month 01 Day
Last follow-up date
2014 Year 01 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 10 Month 16 Day
Last modified on
2010 Year 04 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002615

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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