Nobori Dual Antiplatelet Therapy as Appropriate Duration

Phase 4

Completed

• Conditions: Coronary Artery Disease
• Interventions: Drug: Aspirin or thienopyridine; Drug: Aspirin and thienopyridine

• Registration Number: NCT01514227
• Lead Sponsor: Associations for Establishment of Evidence in Interventions

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12
• Study First Submitted: 2011-12-22
• Study First Submitted QC: 2012-01-20
• Study First Posted: 2012-01-23
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-26
• Last Update Posted: 2017-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3773

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Short-term DAPT (6 months) group	Aspirin or thienopyridine	6 months DAPT (aspirin and thienopyridine) prescription following Nobori stent
Long-term DAPT (18 months) group	Aspirin and thienopyridine	18 months DAPT (aspirin and thienopyridine) prescription following Nobori stent

Primary Outcome Measures

Name	Time	Method
Net adverse clinical and cerebral event (NACCE)	18 months	NACCE include all-cause death, non-fatal myocardial infarction, cerebrovascular events, and major bleeding.

Secondary Outcome Measures

Name	Time	Method
Rate of target lesion revascularization	18 months
Minor bleeding	18 months
All-cause death	18 months
Non-fatal myocardial infarction	18 months
Cerebrovascular events	18 months
Major bleeding	18 months

Trial Locations

Locations (1)

Non-profit organization Associations for Establishment of Evidence in Interventions; 🇯🇵 Minato-ku, Tokyo, Japan