Nobori Dual Antiplatelet Therapy as Appropriate Duration

Associations for Establishment of Evidence in Interventions

Status and phase: Completed; Phase 4

Conditions: Coronary Artery Disease

Treatments: Drug: Aspirin and thienopyridine; Drug: Aspirin or thienopyridine

Study type: Interventional

Funder types: Other

Identifiers

NCT01514227

NIPPON 5.0

Details and patient eligibility

About

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

Enrollment: 3,773 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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3,773 participants in 2 patient groups

Short-term DAPT (6 months) group

Experimental group

Description:

6 months DAPT (aspirin and thienopyridine) prescription following Nobori stent

Treatment:

Drug: Aspirin or thienopyridine

Long-term DAPT (18 months) group

Experimental group

Description:

18 months DAPT (aspirin and thienopyridine) prescription following Nobori stent

Treatment:

Drug: Aspirin and thienopyridine