Nobori Dual Antiplatelet Therapy as Appropriate Duration

• Status: Completed
• Trial end date: 2016-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Associations for Establishment of Evidence in Interventions
• Treatments: Aspirin

Criteria

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