search
Back to results

Nobori Dual Antiplatelet Therapy as Appropriate Duration

Primary Purpose

Coronary Artery Disease

Status
Completed
Phase
Phase 4
Locations
Japan
Study Type
Interventional
Intervention
Aspirin or thienopyridine
Aspirin and thienopyridine
Sponsored by
Associations for Establishment of Evidence in Interventions
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Non-profit organization Associations for Establishment of Evidence in Interventions

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Short-term DAPT (6 months) group

Long-term DAPT (18 months) group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

All-cause death
Non-fatal myocardial infarction
Cerebrovascular events
Major bleeding
Rate of target lesion revascularization
Minor bleeding

Full Information

First Posted
December 22, 2011
Last Updated
January 26, 2017
Sponsor
Associations for Establishment of Evidence in Interventions
search

1. Study Identification

Unique Protocol Identification Number
NCT01514227
Brief Title
Nobori Dual Antiplatelet Therapy as Appropriate Duration
Official Title
Nobori Dual Antiplatelet Therapy as Appropriate Duration.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
December 2011 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Associations for Establishment of Evidence in Interventions

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
3773 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Short-term DAPT (6 months) group
Arm Type
Experimental
Arm Description
6 months DAPT (aspirin and thienopyridine) prescription following Nobori stent
Arm Title
Long-term DAPT (18 months) group
Arm Type
Experimental
Arm Description
18 months DAPT (aspirin and thienopyridine) prescription following Nobori stent
Intervention Type
Drug
Intervention Name(s)
Aspirin or thienopyridine
Intervention Description
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
Intervention Name(s)
Aspirin and thienopyridine
Intervention Description
Subjects randomized 18 month DAPT will be prescribed both aspirin and thienopyridine (clopidogrel or ticlopidine) for 18 month after stenting.
Primary Outcome Measure Information:
Title
Net adverse clinical and cerebral event (NACCE)
Description
NACCE include all-cause death, non-fatal myocardial infarction, cerebrovascular events, and major bleeding.
Time Frame
18 months
Secondary Outcome Measure Information:
Title
All-cause death
Time Frame
18 months
Title
Non-fatal myocardial infarction
Time Frame
18 months
Title
Cerebrovascular events
Time Frame
18 months
Title
Major bleeding
Time Frame
18 months
Title
Rate of target lesion revascularization
Time Frame
18 months
Title
Minor bleeding
Time Frame
18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Non-profit organization Associations for Establishment of Evidence in Interventions
City
Minato-ku
State/Province
Tokyo
ZIP/Postal Code
105-0013
Country
Japan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28641838
Citation
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.
Results Reference
derived

Learn more about this trial

Nobori Dual Antiplatelet Therapy as Appropriate Duration

We'll reach out to this number within 24 hrs