Nobori And Uncoated Stent In Coronary Attack

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01401036
Recruitment Status : Unknown
Verified November 2014 by Shigeru Saito, NAUSICA Investigators.
Recruitment status was:  Recruiting
First Posted : July 25, 2011
Last Update Posted : December 2, 2014
NPO International TRI Network
Information provided by (Responsible Party):
Shigeru Saito, NAUSICA Investigators

July 20, 2011
July 25, 2011
December 2, 2014
July 2011
July 2017   (Final data collection date for primary outcome measure)
major adverse cardiac and cerebrovascular events (MACE) [ Time Frame: 1 year ]
MACE includes all-cause death, myocardial infarction, cerebrovascular events, and target lesion revascularization
Same as current
Complete list of historical versions of study NCT01401036 on Archive Site
  • major adverse cardiac and cerebrovascular events (MACE) [ Time Frame: 1 week ]
    MACE includes all-cause death, myocardial infarction, cerebrovascular events, and target lesion revascularization
  • stent thrombosis [ Time Frame: 1 week and 1 year ]
  • target lesion revascularization [ Time Frame: 1 year ]
Same as current
Not Provided
Not Provided
Nobori And Uncoated Stent In Coronary Attack
Clinical Trial of Nobori Versus Uncoated Stents In Acute Myocardial Infarction
Drug-eluting stents reduce rates of restenosis and reintervention, as compared with uncoated stents. Data are limited regarding the safety and efficacy of Nobori (Biolimus A9 Eluting Stent) in primary percutaneous coronary intervention (PCI) for acute myocardial infarction (AMI). Accordingly, the investigators will compare the outcomes of primary PCI for AMI between patients receiving Nobori versus uncoated stents.
Not Provided
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Acute Myocardial Infarction
  • Device: Biolimus A9 eluting stents
    implantation of Biolimus A9 eluting stents
    Other Name: Nobori® Drug Eluting Stent made by Terumo Corporation
  • Procedure: uncoated stent
    implantation of any uncoated bare metal stents currently available in Japan
  • Active Comparator: Nobori
    subjects receiving Biolimus A9 eluting stent implantation
    Intervention: Device: Biolimus A9 eluting stents
  • Sham Comparator: Uncoated stents
    subjects receiving uncoated stent implantation
    Intervention: Procedure: uncoated stent
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Unknown status
Same as current
July 2017
July 2017   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • age more than 20 years old
  • chest pain lasting more than 20 min
  • symptoms beginning within 12 hours before characterization
  • electrocardiogram showing ST-segment elevation or new appearance of left bundle branch block
  • increase in cardiac enzymes to more than 5-fold the normal laboratory values
  • infarct-related vessel are anatomically suitable for percutaneous revascularization
  • patients gave their signed, informed consent

Exclusion Criteria:

  • previous stent implantation within 30 days
  • allergy to any of the followings : aspirin, heparin, clopidogrel, biolimus A9 or its derivatives, stainless steel 316L, PLA (Poly-Lactic Acid) Polymer or its derivatives, and contrast media
  • elective surgery scheduled within 6 months
  • renal insufficiency with creatinine level of more than 2.5 mg/dL
  • patients associated with bleeding and/or clotting disorders, and those refusing blood transfusion
  • history of massive gastrointestinal or urinary tract bleeding within 6 months
  • patients currently enrolled in other clinical trials
  • pregnancy
Sexes Eligible for Study: All
20 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
Shigeru Saito, NAUSICA Investigators
Shigeru Saito
NPO International TRI Network
Principal Investigator: Shigeru Saito, MD NPO International TRI Network
NAUSICA Investigators
November 2014

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