Nobori And Uncoated Stent In Coronary Attack
This study is currently recruiting participants.
Verified June 2012 by NAUSICA Investigators
Sponsor:
Shigeru Saito
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
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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: | August 2013 |
| Estimated Primary Completion Date: | August 2013 (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
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: Satoshi Takeshita, MD | +81-467-46-1717 | stake@muse.ocn.ne.jp |
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: Satoshi Takeshita, MD +81-467-46-1717 stake@muse.ocn.ne.jp | |
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: | June 20, 2012 |
| 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 June 18, 2013