Nobori Dual Antiplatelet Therapy as Appropriate Duration

Study Overview
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Brief Summary
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NIPPON trial is a prospective, randomized, trial comparing 6 and 18 months Dual Antiplatelet Therapy (DAPT) following Nobori stent deployment.

Official Title
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Nobori Dual Antiplatelet Therapy as Appropriate Duration.

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Drug: Aspirin or thienopyridine
* Drug: Aspirin and thienopyridine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects > 20 years old Undergoing percutaneous intervention with Nobori deployment No contraindication to prolonged DAPT Exclusion Criteria: Subjects absolutely necessitating continuous DAPT Planned surgery necessitating discontinuation of antiplatelet therapy after enrollment. Active pathological bleeding Status of cardiogenic shock at enrollment Pregnant women Life expectancy of < 1.5 years Subjects unable to give informed consent Episode of stroke < 6 months Subjects with allergies or hypersensitivity to material of coating, Biolimus A9, and antiplatelet drugs. Subjects treated with other kind of DES or BMS during the index procedure Previous intervention with DES < 6 months. Study participation impractical per investigator judgment

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 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 |
| --- | --- |
| Experimental: Short-term DAPT (6 months) group<br>6 months DAPT (aspirin and thienopyridine) prescription following Nobori stent | Drug: Aspirin or thienopyridine<br>* Subjects randomized 6 month DAPT will be prescribed either aspirin or thienopyridine (clopidogrel or ticlopidine) following 6 months DAPT for the duration of study, which is left on the physician's discretion.<br>|
| Experimental: Long-term DAPT (18 months) group<br>18 months DAPT (aspirin and thienopyridine) prescription following Nobori stent | Drug: Aspirin and thienopyridine<br>* Subjects randomized 18 month DAPT will be prescribed both aspirin and thienopyridine (clopidogrel or ticlopidine) for 18 month after stenting.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Net adverse clinical and cerebral event (NACCE) | NACCE include all-cause death, non-fatal myocardial infarction, cerebrovascular events, and major bleeding. | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause death |  | 18 months | 
| Non-fatal myocardial infarction |  | 18 months | 
| Cerebrovascular events |  | 18 months | 
| Major bleeding |  | 18 months | 
| Rate of target lesion revascularization |  | 18 months | 
| Minor bleeding |  | 18 months |