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
  Purpose

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.


Condition Intervention Phase
Coronary Artery Disease
Device: Biolimus-eluting stent
Device: Everolimus-eluting stent
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: NOBORI Biolimus-Eluting Versus XIENCE/PROMUS Everolimus-eluting Stent Trial

Resource links provided by NLM:


Further study details as provided by Kyoto University, Graduate School of Medicine:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 3200
Study Start Date: May 2011
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Biolimus-eluting stent
Biolimus-eluting stent
Device: Biolimus-eluting stent
Biolimus-eluting stent
Active Comparator: Everolimus-eluting stent
Everolimus-eluting stent
Device: Everolimus-eluting stent
Everolimus-eluting stent

Detailed Description:

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients scheduled for percutaneous coronary intervention using drug-eluting stents
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01303640

Contacts
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

Locations
Japan
Department of Cardiovascular Medicine, Kyoto University Hospital Recruiting
Kyoto, Japan, 606-8507
Contact: Takeshi Kimura, MD, PhD    +81-75-751-4254    taketaka@kuhp.kyoto-u.ac.jp   
Contact: Masao Imai, MD    +81-75-751-4255    imai@kuhp.kyoto-u.ac.jp   
Principal Investigator: Takeshi Kimura, MD, PhD         
Sponsors and Collaborators
Takeshi Morimoto
Investigators
Principal Investigator: Takeshi Kimura, MD, PhD Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine
  More Information

No publications provided by Kyoto University, Graduate School of Medicine

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Takeshi Morimoto, Professor, Kyoto University, Graduate School of Medicine
ClinicalTrials.gov Identifier: NCT01303640     History of Changes
Other Study ID Numbers: C494
Study First Received: February 24, 2011
Last Updated: July 30, 2012
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Kyoto University, Graduate School of Medicine:
Coronary stent

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Everolimus
Sirolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents

ClinicalTrials.gov processed this record on August 25, 2014