Clinical trial NCT01401036: Nobori And Uncoated Stent In Coronary Attack
Official title: Clinical Trial of Nobori Versus Uncoated Stents In Acute Myocardial Infarction
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Acute Myocardial Infarction
Keywords: acute myocardial infarction
stents
angioplasty
thrombosis
Lead sponsor: NAUSICA Investigators
Sponsor class: NETWORK
Collaborators: name: NPO International TRI Network
First posted: 2011-07-25
Enrollment: 1537
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: major adverse cardiac and cerebrovascular events (MACE)
timeFrame: 1 year
Secondary outcomes:
measure: major adverse cardiac and cerebrovascular events (MACE)
timeFrame: 1 week
measure: stent thrombosis
timeFrame: 1 week and 1 year
measure: target lesion revascularization
timeFrame: 1 year
Other outcomes:
Locations:
city: Atsugi
country: Japan
facility: Shonan Atsugi Hospital
state: Kanagawa
city: Kamakura
country: Japan
facility: Shonan Kamakura General Hospital
state: Kanagawa
city: Akishima
country: Japan
facility: Tokyo nishi tokusyukai hospital
city: Atsugi
country: Japan
facility: Shonan Atsugi hospital
city: Hachioji
country: Japan
facility: Tokai University Hachioji Hospital
city: Hakodate
country: Japan
facility: Hakodate Municipal Hospital
city: Hiratsuka
country: Japan
facility: Hiratsuka kyosai hospital
city: Isehara
country: Japan
facility: Tokai University Hospital
city: Ishikawa
country: Japan
facility: Ishikawa Prefectural Central Hospital
city: Kanazawa
country: Japan
facility: Kanazawa Cardiovascular Hospital
city: Kasukabe
country: Japan
facility: Kasukabe chuo general Hospital
city: Kawasaki
country: Japan
facility: St.Marianna University School of Medicine Hospital
city: Kochi
country: Japan
facility: Chikamori Hospital
city: Komaki
country: Japan
facility: Komaki Municipal Hospital
city: Koshigoe
country: Japan
facility: Saitama Tobu Junkanki Hospital
city: Kurashiki
country: Japan
facility: Kurashiki Sentral Hospital
city: Kyoto
country: Japan
facility: Kyoto Katsura Hospital
city: Miura
country: Japan
facility: Hayama Heart Center
city: Omuta
country: Japan
facility: Omuta Tenryo Hospital
city: Osaki
country: Japan
facility: Osaki citizen hospital
city: Sagamihara
country: Japan
facility: Toshiba Rinkan Hospital
city: Saga
country: Japan
facility: Saga Medical University Hospital
city: Saga
country: Japan
facility: Saga-ken Medical Center Koseikan
city: Sapporo
country: Japan
facility: Hokkaido Syakaihoken Hospital
city: Sapporo
country: Japan
facility: Sapporo Hogashi Tokusyukai Hospital
city: Sapporo
country: Japan
facility: Sapporo Tokusyukai Hospital
city: Sasebo
country: Japan
facility: Sasebo Chuo hospital
city: Seto
country: Japan
facility: Tosei General Hospital
city: Shimotsuke
country: Japan
facility: Jichi Medical University Hospital
city: Suma
country: Japan
facility: Sakurakai Takahashi Hospital
city: Tokushima
country: Japan
facility: Taoka Hospital
city: Tokushima
country: Japan
facility: Tokushima medical university hospital
city: Tokyo
country: Japan
facility: Imus Katsushika Heart Center
city: Tokyo
country: Japan
facility: Showa University Fujigaoka Hospital
city: Tokyo
country: Japan
facility: Showa University Hospital
city: Tokyo
country: Japan
facility: The Cardiovascular Institute
city: Tokyo
country: Japan
facility: Toho University Hospital
city: Tokyo
country: Japan
facility: Toho university ohashi medical center
city: Tokyo
country: Japan
facility: Tokyo Medical and Dental Universtity Hospital
city: Tokyo
country: Japan
facility: Tokyo medical University hospital
city: Toyama
country: Japan
facility: Toyama Prefectural Central Hospital
city: Unzen
country: Japan
facility: Izumikawa Hospital
city: Urazoe
country: Japan
facility: Urazoe general hospital
city: Yamagata
country: Japan
facility: Shonai Amarume Hospital
city: Yamaguchi
country: Japan
facility: Saiseikai Yamaguchi General Hospital
city: Yamato
country: Japan
facility: Yamato Seiwa Hospital
city: Yao
country: Japan
facility: Yao General Hospital
city: Yokohama
country: Japan
facility: Kanagawa Cardiovascular and Respiratory Center
city: Yokohama
country: Japan
facility: Saiseikai Yokohama Tobu Hospital
city: Yokohama
country: Japan
facility: Yokohama Medical University Hospital
Study officials:
affiliation: NPO International TRI Network
name: Shigeru Saito, MD
role: PRINCIPAL_INVESTIGATOR
References: