Nobori And Uncoated Stent In Coronary Attack

Study Overview
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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.

Official Title
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Clinical Trial of Nobori Versus Uncoated Stents In Acute Myocardial Infarction

Conditions
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Acute Myocardial Infarction

Intervention / Treatment
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* Device: Biolimus A9 eluting stents
* Procedure: uncoated stent


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Nobori<br>subjects receiving Biolimus A9 eluting stent implantation | Device: Biolimus A9 eluting stents<br>* implantation of Biolimus A9 eluting stents<br>* Other names: Nobori® Drug Eluting Stent made by Terumo Corporation;|
| Sham Comparator: Uncoated stents<br>subjects receiving uncoated stent implantation | Procedure: uncoated stent<br>* implantation of any uncoated bare metal stents currently available in Japan<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| major adverse cardiac and cerebrovascular events (MACE) | MACE includes all-cause death, myocardial infarction, cerebrovascular events, and target lesion revascularization | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| major adverse cardiac and cerebrovascular events (MACE) | MACE includes all-cause death, myocardial infarction, cerebrovascular events, and target lesion revascularization | 1 week | 
| stent thrombosis |  | 1 week and 1 year | 
| target lesion revascularization |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acute myocardial infarction, stents, angioplasty, thrombosis