UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002634 |
|---|---|
| Receipt number | 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 | 2021/02/20 10:22:58 |
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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
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
ttamu@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
RESET trial
Institute
Department
Personal name
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
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
https://www.ahajournals.org/loi/circ/group/d2010.y2019
Publication of results
Published
Result
URL related to results and publications
https://www.ahajournals.org/loi/circ/group/d2010.y2019
Number of participants that the trial has enrolled
3197
Results
From February and July 2010, 3197 patients
were randomly assigned to receive either EES (1597 patients) or SES (1600 patients). At 1 year, the primary efficacy end point
of target-lesion revascularization occurred in 65 patients (4.3%) in the EES group and in 76 patients (5.0%) in the SES group,
demonstrating noninferiority of EES to SES (Pnoninferiority<0.0001, and Psuperiority<0.34). Cumulative incidence of definite
stent thrombosis was low and similar between the 2 groups (0.32% versus 0.38%, P<0.77).
Results date posted
| 2021 | Year | 02 | Month | 20 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
All-comer trial
Participant flow
Randomization
Adverse events
death, ST, procedure related adverse events
Outcome measures
TLR
death/MI
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2009 | Year | 07 | Month | 27 | Day |
Date of IRB
| 2009 | Year | 11 | Month | 18 | Day |
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
| 2021 | Year | 02 | Month | 20 | Day |
Link to view the page
Value
https://center6.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 | |
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| Registered date | File name |
