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Nobori And Uncoated Stent In Coronary Attack

This study is currently recruiting participants.
Verified June 2012 by NAUSICA Investigators
Sponsor:
Collaborator:
NPO International TRI Network
Information provided by (Responsible Party):
Shigeru Saito, NAUSICA Investigators
ClinicalTrials.gov Identifier:
NCT01401036
First received: July 20, 2011
Last updated: June 20, 2012
Last verified: June 2012
History of Changes

July 20, 2011
June 20, 2012
July 2011
August 2013   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01401036 on ClinicalTrials.gov Archive Site
  • 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 ]
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
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1400
August 2013
August 2013   (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
Both
20 Years and older
No
Contact: Shigeru Saito, MD +81-467-46-1717 ext 10490 transradial@kamakuraheart.org
Contact: Satoshi Takeshita, MD +81-467-46-1717 stake@muse.ocn.ne.jp
Japan
 
NCT01401036
20110629
Yes
Shigeru Saito, NAUSICA Investigators
Shigeru Saito
NPO International TRI Network
Principal Investigator: Shigeru Saito, MD NPO International TRI Network
NAUSICA Investigators
June 2012

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