Status:
COMPLETED
Nobori Dual Antiplatelet Therapy as Appropriate Duration
Lead Sponsor:
Associations for Establishment of Evidence in Interventions
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
20-80 years
Phase:
PHASE4
Brief Summary
NIPPON trial is a prospective, randomized, trial comparing 6 and 18 months Dual Antiplatelet Therapy (DAPT) following Nobori stent deployment.
Eligibility Criteria
Inclusion
- Subjects \> 20 years old
- Undergoing percutaneous intervention with Nobori deployment
- No contraindication to prolonged DAPT
Exclusion
- 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
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2016
Estimated Enrollment :
3773 Patients enrolled
Trial Details
Trial ID
NCT01514227
Start Date
December 1 2011
End Date
June 1 2016
Last Update
January 27 2017
Active Locations (1)
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1
Non-profit organization Associations for Establishment of Evidence in Interventions
Minato-ku, Tokyo, Japan, 105-0013