- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01035450
Randomized Evaluation of Sirolimus-eluting Versus Everolimus-eluting Stent Trial (RESET)
December 9, 2015 updated by: Takeshi Morimoto
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
3206
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Kyoto, Japan, 606-8507
- Division of Cardiology, Kyoto University Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients scheduled for percutaneous coronary intervention using drug-eluting stents
Exclusion Criteria:
- None
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Everolimus-eluting stent
|
Everolimus-eluting stent
|
Active Comparator: Sirolimus-eluting stent
|
Sirolimus-eluting stent
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
target-lesion revascularization
Time Frame: 1-year
|
1-year
|
all-cause death or myocardial infarction
Time Frame: 3-year
|
3-year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
all-cause death
Time Frame: 3-year
|
3-year
|
cardiac death
Time Frame: 3-year
|
3-year
|
myocardial infarction
Time Frame: 3-year
|
3-year
|
stent thrombosis (Academic Research Consortium definition)
Time Frame: 3-year
|
3-year
|
ischemic and hemorrhagic strokes excluding transient ischemic attacks and secondary causes
Time Frame: 3-year
|
3-year
|
bleeding complications (GUSTO and TIMI definition)
Time Frame: 3-year
|
3-year
|
stent deployment success
Time Frame: at implantation
|
at implantation
|
procedure time
Time Frame: at implantation
|
at implantation
|
clinically-driven target-lesion revascularization
Time Frame: 3-year
|
3-year
|
non-target-lesion revascularization
Time Frame: 3-year
|
3-year
|
coronary artery bypass grafting
Time Frame: 3-year
|
3-year
|
target-vessel revascularization
Time Frame: 3-year
|
3-year
|
any repeat coronary revascularization
Time Frame: 3-year
|
3-year
|
composite of cardiac death, myocardial infarction in the territory of the target vessel or target-lesion revascularization
Time Frame: 3-year
|
3-year
|
composite of all-cause death, any myocardial infarction or any repeat coronary revascularization
Time Frame: 3-year
|
3-year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Takeshi Kimura, MD, Professor of Medicine, Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2010
Primary Completion (Actual)
March 1, 2014
Study Completion (Actual)
May 1, 2014
Study Registration Dates
First Submitted
December 16, 2009
First Submitted That Met QC Criteria
December 17, 2009
First Posted (Estimate)
December 18, 2009
Study Record Updates
Last Update Posted (Estimate)
December 10, 2015
Last Update Submitted That Met QC Criteria
December 9, 2015
Last Verified
December 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Myocardial Ischemia
- Heart Diseases
- Cardiovascular Diseases
- Vascular Diseases
- Arteriosclerosis
- Arterial Occlusive Diseases
- Coronary Disease
- Coronary Artery Disease
- Physiological Effects of Drugs
- Anti-Infective Agents
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Anti-Bacterial Agents
- Antibiotics, Antineoplastic
- Antifungal Agents
- Everolimus
- Sirolimus
Other Study ID Numbers
- C338
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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