Nobori Dual Antiplatelet Therapy as Appropriate Duration

NCT ID: NCT01514227

Last Updated: 2017-01-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 3773 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-12-31
• Study Completion Date: 2016-06-30

Brief Summary

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

Conditions

Coronary Artery Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Short-term DAPT (6 months) group

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

Group Type: EXPERIMENTAL

Aspirin or thienopyridine

Intervention Type: DRUG

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.

Long-term DAPT (18 months) group

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

Group Type: EXPERIMENTAL

Aspirin and thienopyridine

Intervention Type: DRUG

Subjects randomized 18 month DAPT will be prescribed both aspirin and thienopyridine (clopidogrel or ticlopidine) for 18 month after stenting.

Interventions

Aspirin or thienopyridine

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.

Intervention Type: DRUG

Aspirin and thienopyridine

Subjects randomized 18 month DAPT will be prescribed both aspirin and thienopyridine (clopidogrel or ticlopidine) for 18 month after stenting.

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Associations for Establishment of Evidence in Interventions

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Non-profit organization Associations for Establishment of Evidence in Interventions

Minato-ku, Tokyo, Japan

Countries

Japan

References

Nakamura M, Iijima R, Ako J, Shinke T, Okada H, Ito Y, Ando K, Anzai H, Tanaka H, Ueda Y, Takiuchi S, Nishida Y, Ohira H, Kawaguchi K, Kadotani M, Niinuma H, Omiya K, Morita T, Zen K, Yasaka Y, Inoue K, Ishiwata S, Ochiai M, Hamasaki T, Yokoi H; NIPPON Investigators. Dual Antiplatelet Therapy for 6 Versus 18 Months After Biodegradable Polymer Drug-Eluting Stent Implantation. JACC Cardiovasc Interv. 2017 Jun 26;10(12):1189-1198. doi: 10.1016/j.jcin.2017.04.019.

Reference Type: DERIVED

PMID: 28641838 (View on PubMed)

Other Identifiers

NIPPON 5.0

Identifier Type: -

Identifier Source: org_study_id