Coronary Artery DiseasePhase 4RESETNCT01035450

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

A Phase 4 study testing Everolimus-eluting stent and Sirolimus-eluting stent in people with Coronary Artery Disease, run by Takeshi Morimoto at 1 site in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Any age
Conditions the study is for: Coronary Artery Disease
What is being tested?: Everolimus-eluting stent and Sirolimus-eluting stent
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 3,206 participants
Where: 1 siteJapan
Study dates: Feb 2010to May 2014
Phase: Phase 4
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Patients scheduled for percutaneous coronary intervention using drug-eluting stents

Who cannot join

None

Trial locations and contacts

1 site in 1 country.

Japan1 site

Division of Cardiology, Kyoto University Hospital
Kyoto, Kyoto, 606-8507

Other trials in Japan

About this study

Read the 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.

Conditions: Coronary Artery Disease
Being tested: Everolimus-eluting stent, Sirolimus-eluting stent
Keywords: Coronary stent
Medical subject headings: Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Everolimus-eluting stentDevice
Everolimus-eluting stent
Sirolimus-eluting stentDevice
Sirolimus-eluting stent

Study groups in NCT01035450
Study group	Role	What they receive
Everolimus-eluting stent	Experimental	Not described Receives: Device: Everolimus-eluting stent
Sirolimus-eluting stent	Active comparator	Not described Receives: Device: Sirolimus-eluting stent

What is being measured

The primary outcome is the main question the study is designed to answer.

target-lesion revascularization
Measured: 1-year
all-cause death or myocardial infarction
Measured: 3-year

Secondary outcomes (15)

all-cause death
Measured: 3-year
cardiac death
Measured: 3-year
myocardial infarction
Measured: 3-year
stent thrombosis (Academic Research Consortium definition)
Measured: 3-year
ischemic and hemorrhagic strokes excluding transient ischemic attacks and secondary causes
Measured: 3-year
bleeding complications (GUSTO and TIMI definition)
Measured: 3-year
stent deployment success
Measured: at implantation
procedure time
Measured: at implantation
clinically-driven target-lesion revascularization
Measured: 3-year
non-target-lesion revascularization
Measured: 3-year
coronary artery bypass grafting
Measured: 3-year
target-vessel revascularization
Measured: 3-year
any repeat coronary revascularization
Measured: 3-year
composite of cardiac death, myocardial infarction in the territory of the target vessel or target-lesion revascularization
Measured: 3-year
composite of all-cause death, any myocardial infarction or any repeat coronary revascularization
Measured: 3-year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2010May 2014

First posted18 Dec 2009 (estimated)
Study startFeb 2010
Primary completionMar 2014
Study completionMay 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (7)Papers the sponsor has linked to this study.
Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 3,206 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01035450
Sponsor's protocol ID: C338
Acronym: RESET
Status last verified: Dec 2015
First submitted: 16 Dec 2009
Last updated: 10 Dec 2015
Results posted: No
Data monitoring committee: Yes

Publications

Shiomi H, Kozuma K, Morimoto T, Kadota K, Tanabe K, Morino Y, Tamura T, Abe M, Suwa S, Ito Y, Kobayashi M, Dai K, Nakao K, Tarutani Y, Taniguchi R, Nishikawa H, Yamamoto Y, Yamasaki T, Okamura A, Nakagawa Y, Ando K, Kobayashi K, Kawai K, Hibi K, Kimura T; RESET Investigators. Ten-year clinical outcomes from a randomized trial comparing new-generation everolimus-eluting stent versus first-generation Sirolimus-eluting stent: Results from the RESET extended study. Catheter Cardiovasc Interv. 2023 Oct;102(4):594-607. doi: 10.1002/ccd.30791. Epub 2023 Aug 6.
PubMed 37545171
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.
PubMed 30947938
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.
PubMed 29628128
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.
PubMed 29508236
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.
PubMed 24803436
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.
PubMed 23608784
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.
PubMed 22824435

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 10 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Randomized Evaluation of Sirolimus-eluting Versus Everolimus-eluting Stent Trial
ClinicalTrials.gov ID: NCT01035450
Acronym / sponsor ID: RESET / C338
Conditions: Coronary Artery Disease
Keywords: Coronary stent
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 3,206 participants (actual)
Lead sponsor: Takeshi MorimotoUniversity, hospital or other
Study start: Feb 2010
Primary completion: Mar 2014 (actual)
Study completion: May 2014 (actual)
First posted: 18 Dec 2009 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Everolimus-eluting stent	Experimental	Device: Everolimus-eluting stent
Sirolimus-eluting stent	Active comparator	Device: Sirolimus-eluting stent

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (1 listed)

Patients scheduled for percutaneous coronary intervention using drug-eluting stents

Key exclusion criteria (1 listed)

None

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Everolimus-eluting stentEverolimus-eluting stent	Device	Everolimus-eluting stent
Sirolimus-eluting stentSirolimus-eluting stent	Device	Sirolimus-eluting stent

Primary outcome

target-lesion revascularization
Time frame: 1-year
all-cause death or myocardial infarction
Time frame: 3-year

15 secondary outcomes

all-cause death
Time frame: 3-year
cardiac death
Time frame: 3-year
myocardial infarction
Time frame: 3-year
stent thrombosis (Academic Research Consortium definition)
Time frame: 3-year
ischemic and hemorrhagic strokes excluding transient ischemic attacks and secondary causes
Time frame: 3-year
bleeding complications (GUSTO and TIMI definition)
Time frame: 3-year
stent deployment success
Time frame: at implantation
procedure time
Time frame: at implantation
clinically-driven target-lesion revascularization
Time frame: 3-year
non-target-lesion revascularization
Time frame: 3-year
coronary artery bypass grafting
Time frame: 3-year
target-vessel revascularization
Time frame: 3-year
any repeat coronary revascularization
Time frame: 3-year
composite of cardiac death, myocardial infarction in the territory of the target vessel or target-lesion revascularization
Time frame: 3-year
composite of all-cause death, any myocardial infarction or any repeat coronary revascularization
Time frame: 3-year

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2015.
Derived from this study: PubMed 37545171Shiomi H, Kozuma K, Morimoto T, Kadota K, Tanabe K, Morino Y, Tamura T, Abe M, Suwa S, Ito Y, Kobayashi M, Dai K, Nakao K, Tarutani Y, Taniguchi R, Nishikawa H, Yamamoto Y, Yamasaki T, Okamura A, Nakagawa Y, Ando K, Kobayashi K, Kawai K, Hibi K, Kimura T; RESET Investigators. Ten-year clinical outcomes from a randomized trial comparing new-generation everolimus-eluting stent versus first-generation Sirolimus-eluting stent: Results from the RESET extended study. Catheter Cardiovasc Interv. 2023 Oct;102(4):594-607. doi: 10.1002/ccd.30791. Epub 2023 Aug 6.
Derived from this study: PubMed 30947938Shiomi 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.
Derived from this study: PubMed 29628128Ito 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.
Derived from this study: PubMed 29508236Watanabe 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.
Derived from this study: PubMed 24803436Shiomi 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.
Derived from this study: PubMed 23608784Kozuma 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.
Derived from this study: PubMed 22824435Kimura 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Takeshi Kimura, MD principal investigator

Professor of Medicine, Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Everolimus-eluting stent and Sirolimus-eluting stent in people with Coronary Artery Disease, run by Takeshi Morimoto at 1 site in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

target-lesion revascularization (time frame: 1-year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01035450, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2015.