NOBORI Biolimus-Eluting Versus XIENCE/PROMUS Everolimus-eluting Stent Trial (NEXT)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2012 by Kyoto University, Graduate School of Medicine
Sponsor:
Information provided by (Responsible Party):
Takeshi Morimoto, Kyoto University, Graduate School of Medicine
ClinicalTrials.gov Identifier:
NCT01303640
First received: February 24, 2011
Last updated: July 30, 2012
Last verified: July 2012

February 24, 2011
July 30, 2012
May 2011
June 2015   (final data collection date for primary outcome measure)
  • target-lesion revascularization [ Time Frame: 1-year ] [ Designated as safety issue: No ]
    target-lesion revascularization
  • death or myocardial infarction at 3-year after stent implantation [ Time Frame: 3-year ] [ Designated as safety issue: Yes ]
    death or myocardial infarction at 3-year after stent implantation
Same as current
Complete list of historical versions of study NCT01303640 on ClinicalTrials.gov Archive Site
  • all-cause death [ Time Frame: 3-year ] [ Designated as safety issue: Yes ]
    death due to any cause
  • cardiac death [ Time Frame: 3-year ] [ Designated as safety issue: Yes ]
    death due to cardiac origins
  • acute myocardial infarction [ Time Frame: 3-year ] [ Designated as safety issue: Yes ]
    acute myocardial infarction
  • stent thrombosis [ Time Frame: 3-year ] [ Designated as safety issue: Yes ]
    stent thrombosis defined by Academic Reseach Consortium definition
  • stroke [ Time Frame: 3-year ] [ Designated as safety issue: Yes ]
    stroke excluding transient ischemic attacks
  • bleeding complications [ Time Frame: 3-year ] [ Designated as safety issue: Yes ]
    bleeding complications defined by GUSTO and TIMI definitions
  • success rate for stent deployment [ Time Frame: 3-year ] [ Designated as safety issue: No ]
    success rate for stent deployment
  • procedure time [ Time Frame: 3-year ] [ Designated as safety issue: No ]
    procedure time
  • clinically-driven target-lesion revascularization [ Time Frame: 3-year ] [ Designated as safety issue: No ]
    clinically-driven target-lesion revascularization
  • non-target-lesion revascularization [ Time Frame: 3-year ] [ Designated as safety issue: No ]
    non-target-lesion revascularization
  • coronary artery bypass grafting [ Time Frame: 3-year ] [ Designated as safety issue: No ]
    coronary artery bypass grafting
  • target-vessel revascularization [ Time Frame: 3-year ] [ Designated as safety issue: No ]
    target-vessel revascularization
  • any repeat coronary revascularization [ Time Frame: 3-year ] [ Designated as safety issue: No ]
    any repeat coronary revascularization
  • composite of cardiac death, acute myocardial infarction in the territory of the target vessel or target-lesion revascularization [ Time Frame: 3-year ] [ Designated as safety issue: Yes ]
    composite of cardiac death, acute myocardial infarction in the territory of the target vessel or target-lesion revascularization
  • composite of all-cause death, acute myocardial infarction or any repeat coronary revascularization [ Time Frame: 3-year ] [ Designated as safety issue: Yes ]
    composite of all-cause death, acute myocardial infarction or any repeat coronary revascularization
Same as current
Not Provided
Not Provided
 
NOBORI Biolimus-Eluting Versus XIENCE/PROMUS Everolimus-eluting Stent Trial
NOBORI Biolimus-Eluting Versus XIENCE/PROMUS Everolimus-eluting Stent Trial

The purpose of this study is to evaluate whether the newly-approved biolimus-eluting stent is not inferior to the everolimus-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.

Everolimus-eluting stent is the most widely used coronary drug-eluting stent in Japan. Biolimus-eluting stent is a new coronary drug-eluting stent, which is going to be approved in 2011 by the Japanese Ministry of Health, Labor and Welfare. It has been reported that biolimus-eluting stent had lower rate of target-lesion revascularization and stent thrombosis at 9 months as compared with paclitaxel-eluting stent. However, trial results comparing biolimus-eluting stent with everolimus-eluting stent are largely unknown. The purpose of this study is to evaluate whether the newly-approved biolimus-eluting stent is not inferior to the everolimus-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: Biolimus-eluting stent
    Biolimus-eluting stent
  • Device: Everolimus-eluting stent
    Everolimus-eluting stent
  • Active Comparator: Biolimus-eluting stent
    Biolimus-eluting stent
    Intervention: Device: Biolimus-eluting stent
  • Active Comparator: Everolimus-eluting stent
    Everolimus-eluting stent
    Intervention: Device: Everolimus-eluting stent

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
3200
August 2015
June 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients scheduled for percutaneous coronary intervention using drug-eluting stents
Both
Not Provided
No
Contact: Takeshi Kimura, MD, PhD +81-75-751-4254 taketaka@kuhp.kyoto-u.ac.jp
Contact: Takeshi Morimoto, MD, PhD +81-75-751-4890 office@kuhp.kyoto-u.ac.jp
Japan
 
NCT01303640
C494
Yes
Takeshi Morimoto, Kyoto University, Graduate School of Medicine
Takeshi Morimoto
Not Provided
Principal Investigator: Takeshi Kimura, MD, PhD Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine
Kyoto University, Graduate School of Medicine
July 2012

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