Nobori And Uncoated Stent In Coronary Attack

Not Applicable

Terminated

• Conditions: Acute Myocardial Infarction

• Registration Number: NCT01401036
• Lead Sponsor: Shigeru Saito

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-07
• Study First Submitted: 2011-07-20
• Study First Submitted QC: 2011-07-22
• Study First Posted: 2011-07-25
• Primary Completion: 2015-08-05
• Study Completion: 2017-12-07
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-23
• Last Update Posted: 2018-08-27

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1537

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
major adverse cardiac and cerebrovascular events (MACE)	1 year	MACE includes all-cause death, myocardial infarction, cerebrovascular events, and target lesion revascularization

Secondary Outcome Measures

Name	Time	Method
major adverse cardiac and cerebrovascular events (MACE)	1 week	MACE includes all-cause death, myocardial infarction, cerebrovascular events, and target lesion revascularization
target lesion revascularization	1 year
stent thrombosis	1 week and 1 year

Trial Locations

Locations (50)

Shonan Atsugi Hospital; 🇯🇵 Atsugi, Kanagawa, Japan

Shonan Kamakura General Hospital; 🇯🇵 Kamakura, Kanagawa, Japan

Tokyo nishi tokusyukai hospital; 🇯🇵 Akishima, Japan

Shonan Atsugi hospital; 🇯🇵 Atsugi, 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

Kanazawa Cardiovascular Hospital; 🇯🇵 Kanazawa, Japan

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