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Nobori And Uncoated Stent In Coronary Attack

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2014 by Shigeru Saito, NAUSICA Investigators.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01401036
First Posted: July 25, 2011
Last Update Posted: December 2, 2014
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.
Collaborator:
NPO International TRI Network
Information provided by (Responsible Party):
Shigeru Saito, NAUSICA Investigators
  Purpose
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
Intervention Model: Parallel Assignment
Masking: None (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 Shigeru Saito, NAUSICA Investigators:

Primary Outcome Measures:
  • 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:
  • 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 ]

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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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 ClinicalTrials.gov identifier (NCT number): NCT01401036


Contacts
Contact: Shigeru Saito, MD +81-467-46-1717 ext 10490 transradial@kamakuraheart.org
Contact: Saeko Takahashi, MD +81-467-46-1717 saeko@kamakuraheart.org

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

Responsible Party: Shigeru Saito, Director, Cardiology, Shonan Kamakura General Hospital, NAUSICA Investigators
ClinicalTrials.gov Identifier: NCT01401036     History of Changes
Other Study ID Numbers: 20110629
First Submitted: July 20, 2011
First Posted: July 25, 2011
Last Update Posted: December 2, 2014
Last Verified: November 2014

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

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