Nobori And Uncoated Stent In Coronary Attack

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by NAUSICA Investigators
NPO International TRI Network
Information provided by (Responsible Party):
Shigeru Saito, NAUSICA Investigators Identifier:
First received: July 20, 2011
Last updated: November 27, 2014
Last verified: November 2014
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.

Condition Intervention
Acute Myocardial Infarction
Device: Biolimus A9 eluting stents
Procedure: uncoated stent

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Clinical Trial of Nobori Versus Uncoated Stents In Acute Myocardial Infarction

Resource links provided by NLM:

Further study details as provided by NAUSICA Investigators:

Primary Outcome Measures:
  • major adverse cardiac and cerebrovascular events (MACE) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    MACE includes all-cause death, myocardial infarction, cerebrovascular events, and target lesion revascularization

Secondary Outcome Measures:
  • major adverse cardiac and cerebrovascular events (MACE) [ Time Frame: 1 week ] [ Designated as safety issue: Yes ]
    MACE includes all-cause death, myocardial infarction, cerebrovascular events, and target lesion revascularization

  • stent thrombosis [ Time Frame: 1 week and 1 year ] [ Designated as safety issue: Yes ]
  • target lesion revascularization [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 1400
Study Start Date: July 2011
Estimated Study Completion Date: July 2017
Estimated Primary Completion Date: July 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Nobori
subjects receiving Biolimus A9 eluting stent implantation
Device: Biolimus A9 eluting stents
implantation of Biolimus A9 eluting stents
Other Name: Nobori® Drug Eluting Stent made by Terumo Corporation
Sham Comparator: Uncoated stents
subjects receiving uncoated stent implantation
Procedure: uncoated stent
implantation of any uncoated bare metal stents currently available in Japan


Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  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 identifier: NCT01401036

Contact: Shigeru Saito, MD +81-467-46-1717 ext 10490
Contact: Saeko Takahashi, MD +81-467-46-1717

  Show 50 Study Locations
Sponsors and Collaborators
Shigeru Saito
NPO International TRI Network
Principal Investigator: Shigeru Saito, MD NPO International TRI Network
  More Information

No publications provided

Responsible Party: Shigeru Saito, Director, Cardiology, Shonan Kamakura General Hospital, NAUSICA Investigators Identifier: NCT01401036     History of Changes
Other Study ID Numbers: 20110629
Study First Received: July 20, 2011
Last Updated: November 27, 2014
Health Authority: Japan: Institutional Review Board

Keywords provided by NAUSICA Investigators:
acute myocardial infarction

Additional relevant MeSH terms:
Myocardial Infarction
Cardiovascular Diseases
Heart Diseases
Myocardial Ischemia
Pathologic Processes
Vascular Diseases processed this record on November 27, 2015