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Randomized Evaluation of Sirolimus-eluting Versus Everolimus-eluting Stent Trial (RESET)

Primary Purpose

Coronary Artery Disease

Status
Completed
Phase
Phase 4
Locations
Japan
Study Type
Interventional
Intervention
Everolimus-eluting stent
Sirolimus-eluting stent
Sponsored by
Takeshi Morimoto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring Coronary stent

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients scheduled for percutaneous coronary intervention using drug-eluting stents

Exclusion Criteria:

  • None

Sites / Locations

  • Division of Cardiology, Kyoto University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Everolimus-eluting stent

Sirolimus-eluting stent

Arm Description

Outcomes

Primary Outcome Measures

target-lesion revascularization
all-cause death or myocardial infarction

Secondary Outcome Measures

all-cause death
cardiac death
myocardial infarction
stent thrombosis (Academic Research Consortium definition)
ischemic and hemorrhagic strokes excluding transient ischemic attacks and secondary causes
bleeding complications (GUSTO and TIMI definition)
stent deployment success
procedure time
clinically-driven target-lesion revascularization
non-target-lesion revascularization
coronary artery bypass grafting
target-vessel revascularization
any repeat coronary revascularization
composite of cardiac death, myocardial infarction in the territory of the target vessel or target-lesion revascularization
composite of all-cause death, any myocardial infarction or any repeat coronary revascularization

Full Information

First Posted
December 16, 2009
Last Updated
December 9, 2015
Sponsor
Takeshi Morimoto
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1. Study Identification

Unique Protocol Identification Number
NCT01035450
Brief Title
Randomized Evaluation of Sirolimus-eluting Versus Everolimus-eluting Stent Trial
Acronym
RESET
Official Title
Randomized Evaluation of Sirolimus-eluting Versus Everolimus-eluting Stent Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
May 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Takeshi Morimoto

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to evaluate whether the newly-approved everolimus-eluting stent is not inferior to the sirolimus-eluting stent in terms of the rate of target-lesion revascularization at 1-year and death or myocardial infarction at 3-year after stent implantation in the real world clinical practice.
Detailed Description
Sirolimus-eluting stent is the most widely used coronary drug-eluting stent in Japan. Everolimus-eluting stent is a new coronary drug-eluting stent, which is going to be approved in the first quarter of 2010 by the Japanese Ministry of Health, Labor and Welfare. It has recently been reported that everolimus-eluting stent had lower rate of target-lesion revascularization and stent thrombosis at 1 year as compared with paclitaxel-eluting stent. However, trial results comparing everolimus-eluting stent with sirolimus-eluting stent are largely unknown. The purpose of this study is to evaluate whether the newly-approved everolimus-eluting stent is not inferior to the sirolimus-eluting stent in terms of the rate of target-lesion revascularization at 1-year and death or myocardial infarction at 3-year after stent implantation in the real world clinical practice. The design of this study is all-comer design enrolling patients scheduled for percutaneous coronary intervention using drug-eluting stents without any exclusion criteria.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
Coronary stent

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
3206 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Everolimus-eluting stent
Arm Type
Experimental
Arm Title
Sirolimus-eluting stent
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Everolimus-eluting stent
Intervention Description
Everolimus-eluting stent
Intervention Type
Device
Intervention Name(s)
Sirolimus-eluting stent
Intervention Description
Sirolimus-eluting stent
Primary Outcome Measure Information:
Title
target-lesion revascularization
Time Frame
1-year
Title
all-cause death or myocardial infarction
Time Frame
3-year
Secondary Outcome Measure Information:
Title
all-cause death
Time Frame
3-year
Title
cardiac death
Time Frame
3-year
Title
myocardial infarction
Time Frame
3-year
Title
stent thrombosis (Academic Research Consortium definition)
Time Frame
3-year
Title
ischemic and hemorrhagic strokes excluding transient ischemic attacks and secondary causes
Time Frame
3-year
Title
bleeding complications (GUSTO and TIMI definition)
Time Frame
3-year
Title
stent deployment success
Time Frame
at implantation
Title
procedure time
Time Frame
at implantation
Title
clinically-driven target-lesion revascularization
Time Frame
3-year
Title
non-target-lesion revascularization
Time Frame
3-year
Title
coronary artery bypass grafting
Time Frame
3-year
Title
target-vessel revascularization
Time Frame
3-year
Title
any repeat coronary revascularization
Time Frame
3-year
Title
composite of cardiac death, myocardial infarction in the territory of the target vessel or target-lesion revascularization
Time Frame
3-year
Title
composite of all-cause death, any myocardial infarction or any repeat coronary revascularization
Time Frame
3-year

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients scheduled for percutaneous coronary intervention using drug-eluting stents Exclusion Criteria: None
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Takeshi Kimura, MD
Organizational Affiliation
Professor of Medicine, Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Division of Cardiology, Kyoto University Hospital
City
Kyoto
ZIP/Postal Code
606-8507
Country
Japan

12. IPD Sharing Statement

Citations:
PubMed Identifier
30947938
Citation
Shiomi H, Kozuma K, Morimoto T, Kadota K, Tanabe K, Morino Y, Akasaka T, Abe M, Takeji Y, Suwa S, Ito Y, Kobayashi M, Dai K, Nakao K, Tarutani Y, Taniguchi R, Nishikawa H, Yamamoto Y, Nakagawa Y, Ando K, Kobayashi K, Kawai K, Hibi K, Kimura T; RESET Investigators. 7-Year Outcomes of a Randomized Trial Comparing the First-Generation Sirolimus-Eluting Stent Versus the New-Generation Everolimus-Eluting Stent: The RESET Trial. JACC Cardiovasc Interv. 2019 Apr 8;12(7):637-647. doi: 10.1016/j.jcin.2019.01.234.
Results Reference
derived
PubMed Identifier
29628128
Citation
Ito S, Watanabe H, Morimoto T, Yoshikawa Y, Shiomi H, Shizuta S, Ono K, Yamaji K, Soga Y, Hyodo M, Shirai S, Ando K, Horiuchi H, Kimura T. Impact of Baseline Thrombocytopenia on Bleeding and Mortality After Percutaneous Coronary Intervention. Am J Cardiol. 2018 Jun 1;121(11):1304-1314. doi: 10.1016/j.amjcard.2018.02.010. Epub 2018 Mar 1.
Results Reference
derived
PubMed Identifier
29508236
Citation
Watanabe H, Morimoto T, Shiomi H, Yoshikawa Y, Kato T, Saito N, Shizuta S, Ono K, Yamaji K, Ando K, Kaji S, Furukawa Y, Akao M, Ishikawa T, Tamura T, Yamamoto Y, Muramatsu T, Suwa S, Nakagawa Y, Kadota K, Takatsu Y, Nishikawa H, Hiasa Y, Hayashi Y, Miyazaki S, Kimura T. Mortality impact of post-discharge myocardial infarction size after percutaneous coronary intervention: a patient-level pooled analysis from the 4 large-scale Japanese studies. Cardiovasc Interv Ther. 2019 Jan;34(1):47-58. doi: 10.1007/s12928-018-0517-x. Epub 2018 Mar 5.
Results Reference
derived
PubMed Identifier
24803436
Citation
Shiomi H, Kozuma K, Morimoto T, Igarashi K, Kadota K, Tanabe K, Morino Y, Akasaka T, Abe M, Suwa S, Muramatsu T, Kobayashi M, Dai K, Nakao K, Uematsu M, Tarutani Y, Fujii K, Simonton CA, Kimura T; RESET Investigators. Long-term clinical outcomes after everolimus- and sirolimus-eluting coronary stent implantation: final 3-year follow-up of the Randomized Evaluation of Sirolimus-Eluting Versus Everolimus-Eluting Stent Trial. Circ Cardiovasc Interv. 2014 Jun;7(3):343-54. doi: 10.1161/CIRCINTERVENTIONS.113.001322. Epub 2014 May 6.
Results Reference
derived
PubMed Identifier
23608784
Citation
Kozuma K, Kimura T, Kadota K, Suwa S, Kimura K, Iwabuchi M, Kawai K, Miyazawa A, Kawamura M, Nakao K, Asano R, Yamamoto T, Suzuki N, Aoki J, Kyono H, Nakazawa G, Tanabe K, Morino Y, Igarashi K. Angiographic findings of everolimus-eluting as compared to sirolimus-eluting stents: angiographic sub-study from the Randomized Evaluation of Sirolimus-eluting versus Everolimus-eluting stent Trial (RESET). Cardiovasc Interv Ther. 2013 Oct;28(4):344-51. doi: 10.1007/s12928-013-0179-7. Epub 2013 Apr 23.
Results Reference
derived
PubMed Identifier
22824435
Citation
Kimura T, Morimoto T, Natsuaki M, Shiomi H, Igarashi K, Kadota K, Tanabe K, Morino Y, Akasaka T, Takatsu Y, Nishikawa H, Yamamoto Y, Nakagawa Y, Hayashi Y, Iwabuchi M, Umeda H, Kawai K, Okada H, Kimura K, Simonton CA, Kozuma K; RESET Investigators. Comparison of everolimus-eluting and sirolimus-eluting coronary stents: 1-year outcomes from the Randomized Evaluation of Sirolimus-eluting Versus Everolimus-eluting stent Trial (RESET). Circulation. 2012 Sep 4;126(10):1225-36. doi: 10.1161/CIRCULATIONAHA.112.104059. Epub 2012 Jul 23.
Results Reference
derived

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Randomized Evaluation of Sirolimus-eluting Versus Everolimus-eluting Stent Trial

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