Nobori And Uncoated Stent In Coronary Attack

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 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: October 30, 2013
Last verified: October 2013
  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
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

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
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
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 ClinicalTrials.gov identifier: 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

Locations
Japan
Shonan Atsugi Hospital Recruiting
Atsugi, Kanagawa, Japan, 243-0033
Contact: Shinji Tanaka, MD    81-46-223-3636      
Shonan Kamakura General Hospital Recruiting
Kamakura, Kanagawa, Japan, 247-8533
Contact: Saeko Takahashi, MD    +81-467-46-1717    saeko@kamakuraheart.org   
Hakodate Municipal Hospital Recruiting
Hakodate, Japan
Contact: Yasuhiro Makita, MD         
Principal Investigator: Yasuhiro Makita, MD         
Hiratsuka kyosai hospital Recruiting
Hiratsuka, Japan
Contact: Yuko Onishi, MD         
Tokai University Hospital Recruiting
Isehara, Japan
Contact: Yuji Ikari         
Ishikawa Prefectural Central Hospital Recruiting
Ishikawa, Japan
Contact: Kenji Miwa, MD         
Kanazawa Cardiovascular Hospital Recruiting
Kanazawa, Japan
Contact: Masanobu Nakamura, MD         
Kasukabe chuo general Hospital Recruiting
Kasukabe, Japan
Contact: Minoru Shimizu, MD         
Komaki Municipal Hospital Recruiting
Komaki, Japan
Contact: Katsuhiro Kawaguchi, MD         
Kyoto Katsura Hospital Recruiting
Kyoto, Japan
Contact: Shigeru Nakamura, MD         
Hayama Heart Center Recruiting
Miura, Japan
Contact: Hideki Ueno, MD         
Saga-ken Medical Center Koseikan Recruiting
Saga, Japan
Contact: Kenji Sadamatsu, MD         
Saga Medical University Hospital Recruiting
Saga, Japan
Contact: Yutaka Hikichi, MD         
Sapporo Hogashi Tokusyukai Hospital Recruiting
Sapporo, Japan
Contact: Seiji Yamazaki, MD         
Jichi Medical University Hospital Recruiting
Shimotsuke, Japan
Contact: Katsuki Takaaki, MD         
Toho University Hospital Recruiting
Tokyo, Japan
Contact: Kenji Wagatsuma, MD         
Toyama Prefectural Central Hospital Recruiting
Toyama, Japan
Contact: Kazuo Usuda, MD         
Kanagawa Cardiovascular and Respiratory Center Recruiting
Yokohama, Japan
Contact: Kazuki Fukui, MD         
Yokohama Medical University Hospital Recruiting
Yokohama, Japan
Contact: Kiyoshi Hibi, MD         
Sponsors and Collaborators
Shigeru Saito
NPO International TRI Network
Investigators
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
ClinicalTrials.gov Identifier: NCT01401036     History of Changes
Other Study ID Numbers: 20110629
Study First Received: July 20, 2011
Last Updated: October 30, 2013
Health Authority: Japan: Institutional Review Board

Keywords provided by 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

ClinicalTrials.gov processed this record on August 19, 2014