Nobori And Uncoated Stent In Coronary Attack

NCT ID: NCT01401036

Last Updated: 2018-08-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

1537 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-31

Study Completion Date

2017-12-07

Brief Summary

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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.

Detailed Description

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Conditions

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Acute Myocardial Infarction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Nobori

subjects receiving Biolimus A9 eluting stent implantation

Group Type ACTIVE_COMPARATOR

Biolimus A9 eluting stents

Intervention Type DEVICE

implantation of Biolimus A9 eluting stents

Uncoated stents

subjects receiving uncoated stent implantation

Group Type SHAM_COMPARATOR

uncoated stent

Intervention Type PROCEDURE

implantation of any uncoated bare metal stents currently available in Japan

Interventions

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Biolimus A9 eluting stents

implantation of Biolimus A9 eluting stents

Intervention Type DEVICE

uncoated stent

implantation of any uncoated bare metal stents currently available in Japan

Intervention Type PROCEDURE

Other Intervention Names

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Nobori® Drug Eluting Stent made by Terumo Corporation

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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NPO International TRI Network

NETWORK

Sponsor Role collaborator

Shigeru Saito

NETWORK

Sponsor Role lead

Responsible Party

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Shigeru Saito

Director, Cardiology, Shonan Kamakura General Hospital

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Shigeru Saito, MD

Role: PRINCIPAL_INVESTIGATOR

NPO International TRI Network

Locations

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Shonan Atsugi Hospital

Atsugi, Kanagawa, Japan

Site Status

Shonan Kamakura General Hospital

Kamakura, Kanagawa, Japan

Site Status

Tokyo nishi tokusyukai hospital

Akishima, , Japan

Site Status

Shonan Atsugi hospital

Atsugi, , Japan

Site Status

Tokai University Hachioji Hospital

Hachiōji, , Japan

Site Status

Hakodate Municipal Hospital

Hakodate, , Japan

Site Status

Hiratsuka kyosai hospital

Hiratsuka, , Japan

Site Status

Tokai University Hospital

Isehara, , Japan

Site Status

Ishikawa Prefectural Central Hospital

Ishikawa, , Japan

Site Status

Kanazawa Cardiovascular Hospital

Kanazawa, , Japan

Site Status

Kasukabe chuo general Hospital

Kasukabe, , Japan

Site Status

St.Marianna University School of Medicine Hospital

Kawasaki, , Japan

Site Status

Chikamori Hospital

Kochi, , Japan

Site Status

Komaki Municipal Hospital

Komaki, , Japan

Site Status

Saitama Tobu Junkanki Hospital

Koshigoe, , Japan

Site Status

Kurashiki Sentral Hospital

Kurashiki, , Japan

Site Status

Kyoto Katsura Hospital

Kyoto, , Japan

Site Status

Hayama Heart Center

Miura, , Japan

Site Status

Omuta Tenryo Hospital

Omuta, , Japan

Site Status

Osaki citizen hospital

Ōsaki, , Japan

Site Status

Saga Medical University Hospital

Saga, , Japan

Site Status

Saga-ken Medical Center Koseikan

Saga, , Japan

Site Status

Toshiba Rinkan Hospital

Sagamihara, , Japan

Site Status

Hokkaido Syakaihoken Hospital

Sapporo, , Japan

Site Status

Sapporo Hogashi Tokusyukai Hospital

Sapporo, , Japan

Site Status

Sapporo Tokusyukai Hospital

Sapporo, , Japan

Site Status

Sasebo Chuo hospital

Sasebo, , Japan

Site Status

Tosei General Hospital

Seto, , Japan

Site Status

Jichi Medical University Hospital

Shimotsuke, , Japan

Site Status

Sakurakai Takahashi Hospital

Suma, , Japan

Site Status

Taoka Hospital

Tokushima, , Japan

Site Status

Tokushima medical university hospital

Tokushima, , Japan

Site Status

Imus Katsushika Heart Center

Tokyo, , Japan

Site Status

Showa University Fujigaoka Hospital

Tokyo, , Japan

Site Status

Showa University Hospital

Tokyo, , Japan

Site Status

The Cardiovascular Institute

Tokyo, , Japan

Site Status

Toho University Hospital

Tokyo, , Japan

Site Status

Toho university ohashi medical center

Tokyo, , Japan

Site Status

Tokyo Medical and Dental Universtity Hospital

Tokyo, , Japan

Site Status

Tokyo medical University hospital

Tokyo, , Japan

Site Status

Toyama Prefectural Central Hospital

Toyama, , Japan

Site Status

Izumikawa Hospital

Unzen, , Japan

Site Status

Urazoe general hospital

Urazoe, , Japan

Site Status

Shonai Amarume Hospital

Yamagata, , Japan

Site Status

Saiseikai Yamaguchi General Hospital

Yamaguchi, , Japan

Site Status

Yamato Seiwa Hospital

Yamato, , Japan

Site Status

Yao General Hospital

Yao, , Japan

Site Status

Kanagawa Cardiovascular and Respiratory Center

Yokohama, , Japan

Site Status

Saiseikai Yokohama Tobu Hospital

Yokohama, , Japan

Site Status

Yokohama Medical University Hospital

Yokohama, , Japan

Site Status

Countries

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Japan

Other Identifiers

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20110629

Identifier Type: -

Identifier Source: org_study_id

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