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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Takeshi Morimoto, Kyoto University, Graduate School of Medicine
ClinicalTrials.gov Identifier:
NCT01035450
First received: December 16, 2009
Last updated: September 11, 2012
Last verified: September 2012
History of Changes

December 16, 2009
September 11, 2012
February 2010
March 2014   (final data collection date for primary outcome measure)
  • target-lesion revascularization [ Time Frame: 1-year ] [ Designated as safety issue: No ]
  • all-cause death or myocardial infarction [ Time Frame: 3-year ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01035450 on ClinicalTrials.gov Archive Site
  • all-cause death [ Time Frame: 3-year ] [ Designated as safety issue: No ]
  • cardiac death [ Time Frame: 3-year ] [ Designated as safety issue: No ]
  • myocardial infarction [ Time Frame: 3-year ] [ Designated as safety issue: No ]
  • stent thrombosis (Academic Research Consortium definition) [ Time Frame: 3-year ] [ Designated as safety issue: No ]
  • ischemic and hemorrhagic strokes excluding transient ischemic attacks and secondary causes [ Time Frame: 3-year ] [ Designated as safety issue: Yes ]
  • bleeding complications (GUSTO and TIMI definition) [ Time Frame: 3-year ] [ Designated as safety issue: Yes ]
  • stent deployment success [ Time Frame: at implantation ] [ Designated as safety issue: No ]
  • procedure time [ Time Frame: at implantation ] [ Designated as safety issue: No ]
  • clinically-driven target-lesion revascularization [ Time Frame: 3-year ] [ Designated as safety issue: No ]
  • non-target-lesion revascularization [ Time Frame: 3-year ] [ Designated as safety issue: No ]
  • coronary artery bypass grafting [ Time Frame: 3-year ] [ Designated as safety issue: No ]
  • target-vessel revascularization [ Time Frame: 3-year ] [ Designated as safety issue: No ]
  • any repeat coronary revascularization [ Time Frame: 3-year ] [ Designated as safety issue: No ]
  • composite of cardiac death, myocardial infarction in the territory of the target vessel or target-lesion revascularization [ Time Frame: 3-year ] [ Designated as safety issue: No ]
  • composite of all-cause death, any myocardial infarction or any repeat coronary revascularization [ Time Frame: 3-year ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Randomized Evaluation of Sirolimus-eluting Versus Everolimus-eluting Stent Trial
Randomized Evaluation of Sirolimus-eluting Versus Everolimus-eluting Stent Trial

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.

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.
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Coronary Artery Disease
  • Device: Everolimus-eluting stent
    Everolimus-eluting stent
  • Device: Sirolimus-eluting stent
    Sirolimus-eluting stent
  • Experimental: Everolimus-eluting stent
    Intervention: Device: Everolimus-eluting stent
  • Active Comparator: Sirolimus-eluting stent
    Intervention: Device: Sirolimus-eluting stent
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. Epub 2012 Jul 23.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
3200
May 2014
March 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • None
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01035450
C338
Yes
Takeshi Morimoto, Kyoto University, Graduate School of Medicine
Takeshi Morimoto
Not Provided
Principal Investigator: Takeshi Kimura, MD Professor of Medicine, Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine
Kyoto University, Graduate School of Medicine
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP