Nobori And Uncoated Stent In Coronary Attack

Acute Myocardial Infarction Clinical Trial

Official title:

Clinical Trial of Nobori Versus Uncoated Stents In Acute Myocardial Infarction

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01401036
• Other study ID #: 20110629
• Status: Terminated
• Phase: N/A
• Start date: July 2011
• Est. completion date: December 7, 2017

Study information

• Verified date: August 2018
• Source: NAUSICA Investigators
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1537
• Est. completion date: December 7, 2017
• Est. primary completion date: August 5, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Infarction
• Myocardial Infarction

Intervention

Device:
• Biolimus A9 eluting stents
implantation of Biolimus A9 eluting stents

Procedure:
• uncoated stent
implantation of any uncoated bare metal stents currently available in Japan

Locations

Country	Name	City	State
Japan	Tokyo nishi tokusyukai hospital	Akishima
Japan	Shonan Atsugi hospital	Atsugi
Japan	Shonan Atsugi Hospital	Atsugi	Kanagawa
Japan	Tokai University Hachioji Hospital	Hachioji
Japan	Hakodate Municipal Hospital	Hakodate
Japan	Hiratsuka kyosai hospital	Hiratsuka
Japan	Tokai University Hospital	Isehara
Japan	Ishikawa Prefectural Central Hospital	Ishikawa
Japan	Shonan Kamakura General Hospital	Kamakura	Kanagawa
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	Osaki
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
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

Sponsors (2)

Lead Sponsor	Collaborator
Shigeru Saito	NPO International TRI Network

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	major adverse cardiac and cerebrovascular events (MACE)	MACE includes all-cause death, myocardial infarction, cerebrovascular events, and target lesion revascularization	1 year
Secondary	major adverse cardiac and cerebrovascular events (MACE)	MACE includes all-cause death, myocardial infarction, cerebrovascular events, and target lesion revascularization	1 week
Secondary	stent thrombosis		1 week and 1 year
Secondary	target lesion revascularization		1 year