Study Stopped
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Nobori And Uncoated Stent In Coronary Attack
Clinical Trial of Nobori Versus Uncoated Stents In Acute Myocardial Infarction
1 other identifier
interventional
1,537
1 country
50
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2011
Longer than P75 for not_applicable
50 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2011
CompletedFirst Submitted
Initial submission to the registry
July 20, 2011
CompletedFirst Posted
Study publicly available on registry
July 25, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 5, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 7, 2017
CompletedAugust 27, 2018
August 1, 2018
4.1 years
July 20, 2011
August 23, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
major adverse cardiac and cerebrovascular events (MACE)
MACE includes all-cause death, myocardial infarction, cerebrovascular events, and target lesion revascularization
1 year
Secondary Outcomes (3)
major adverse cardiac and cerebrovascular events (MACE)
1 week
stent thrombosis
1 week and 1 year
target lesion revascularization
1 year
Study Arms (2)
Nobori
ACTIVE COMPARATORsubjects receiving Biolimus A9 eluting stent implantation
Uncoated stents
SHAM COMPARATORsubjects receiving uncoated stent implantation
Interventions
implantation of Biolimus A9 eluting stents
implantation of any uncoated bare metal stents currently available in Japan
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Shigeru Saitolead
- NPO International TRI Networkcollaborator
Study Sites (50)
Shonan Atsugi Hospital
Atsugi, Kanagawa, 243-0033, Japan
Shonan Kamakura General Hospital
Kamakura, Kanagawa, 247-8533, Japan
Tokyo nishi tokusyukai hospital
Akishima, Japan
Shonan Atsugi hospital
Atsugi, Japan
Tokai University Hachioji Hospital
Hachiōji, Japan
Hakodate Municipal Hospital
Hakodate, Japan
Hiratsuka kyosai hospital
Hiratsuka, Japan
Tokai University Hospital
Isehara, Japan
Ishikawa Prefectural Central Hospital
Ishikawa, Japan
Kanazawa Cardiovascular Hospital
Kanazawa, Japan
Kasukabe chuo general Hospital
Kasukabe, Japan
St.Marianna University School of Medicine Hospital
Kawasaki, Japan
Chikamori Hospital
Kochi, Japan
Komaki Municipal Hospital
Komaki, Japan
Saitama Tobu Junkanki Hospital
Koshigoe, Japan
Kurashiki Sentral Hospital
Kurashiki, Japan
Kyoto Katsura Hospital
Kyoto, Japan
Hayama Heart Center
Miura, Japan
Omuta Tenryo Hospital
Omuta, Japan
Osaki citizen hospital
Ōsaki, Japan
Saga Medical University Hospital
Saga, Japan
Saga-ken Medical Center Koseikan
Saga, Japan
Toshiba Rinkan Hospital
Sagamihara, Japan
Hokkaido Syakaihoken Hospital
Sapporo, Japan
Sapporo Hogashi Tokusyukai Hospital
Sapporo, Japan
Sapporo Tokusyukai Hospital
Sapporo, Japan
Sasebo Chuo hospital
Sasebo, Japan
Tosei General Hospital
Seto, Japan
Jichi Medical University Hospital
Shimotsuke, Japan
Sakurakai Takahashi Hospital
Suma, Japan
Taoka Hospital
Tokushima, Japan
Tokushima medical university hospital
Tokushima, Japan
Imus Katsushika Heart Center
Tokyo, Japan
Showa University Fujigaoka Hospital
Tokyo, Japan
Showa University Hospital
Tokyo, Japan
The Cardiovascular Institute
Tokyo, Japan
Toho University Hospital
Tokyo, Japan
Toho university ohashi medical center
Tokyo, Japan
Tokyo Medical and Dental Universtity Hospital
Tokyo, Japan
Tokyo medical University hospital
Tokyo, Japan
Toyama Prefectural Central Hospital
Toyama, Japan
Izumikawa Hospital
Unzen, Japan
Urazoe general hospital
Urazoe, Japan
Shonai Amarume Hospital
Yamagata, 9997782, Japan
Saiseikai Yamaguchi General Hospital
Yamaguchi, Japan
Yamato Seiwa Hospital
Yamato, Japan
Yao General Hospital
Yao, Japan
Kanagawa Cardiovascular and Respiratory Center
Yokohama, Japan
Saiseikai Yokohama Tobu Hospital
Yokohama, Japan
Yokohama Medical University Hospital
Yokohama, Japan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Shigeru Saito, MD
NPO International TRI Network
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Director, Cardiology, Shonan Kamakura General Hospital
Study Record Dates
First Submitted
July 20, 2011
First Posted
July 25, 2011
Study Start
July 1, 2011
Primary Completion
August 5, 2015
Study Completion
December 7, 2017
Last Updated
August 27, 2018
Record last verified: 2018-08