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

Brief Summary:
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 or disease Intervention/treatment Phase
Acute Myocardial Infarction Device: Biolimus A9 eluting stents Procedure: uncoated stent Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Trial of Nobori Versus Uncoated Stents In Acute Myocardial Infarction
Study Start Date : July 2011
Estimated Primary Completion Date : July 2017
Estimated Study Completion Date : July 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack
Drug Information available for: Umirolimus

Arm Intervention/treatment
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

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

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

  2. stent thrombosis [ Time Frame: 1 week and 1 year ]
  3. target lesion revascularization [ Time Frame: 1 year ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

Responsible Party: Shigeru Saito, Director, Cardiology, Shonan Kamakura General Hospital, NAUSICA Investigators Identifier: NCT01401036     History of Changes
Other Study ID Numbers: 20110629
First Posted: July 25, 2011    Key Record Dates
Last Update Posted: December 2, 2014
Last Verified: November 2014

Keywords provided by Shigeru Saito, NAUSICA Investigators:
acute myocardial infarction

Additional relevant MeSH terms:
Myocardial Infarction
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Anti-Inflammatory Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents