NCT01514227

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,773

participants targeted

Target at P75+ for phase_4 coronary-artery-disease

Timeline
Completed

Started Dec 2011

Longer than P75 for phase_4 coronary-artery-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2011

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

December 22, 2011

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 23, 2012

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

January 27, 2017

Status Verified

January 1, 2017

Enrollment Period

4.5 years

First QC Date

December 22, 2011

Last Update Submit

January 26, 2017

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

  • Net adverse clinical and cerebral event (NACCE)

    NACCE include all-cause death, non-fatal myocardial infarction, cerebrovascular events, and major bleeding.

    18 months

Secondary Outcomes (6)

  • All-cause death

    18 months

  • Non-fatal myocardial infarction

    18 months

  • Cerebrovascular events

    18 months

  • Major bleeding

    18 months

  • Rate of target lesion revascularization

    18 months

  • +1 more secondary outcomes

Study Arms (2)

Short-term DAPT (6 months) group

EXPERIMENTAL

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

Drug: Aspirin or thienopyridine

Long-term DAPT (18 months) group

EXPERIMENTAL

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

Drug: Aspirin and thienopyridine

Interventions

Aspirin or thienopyridineDRUG

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.

Short-term DAPT (6 months) group
Aspirin and thienopyridineDRUG

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

Long-term DAPT (18 months) group

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects \> 20 years old
  • Undergoing percutaneous intervention with Nobori deployment
  • No contraindication to prolonged DAPT

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Non-profit organization Associations for Establishment of Evidence in Interventions

Minato-ku, Tokyo, 105-0013, Japan

Location

Related Publications (1)

  • 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.

    PMID: 28641838DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Aspirinthienopyridine

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

SalicylatesHydroxybenzoatesPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 22, 2011

First Posted

January 23, 2012

Study Start

December 1, 2011

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

January 27, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share

Locations

JP(1)