Nobori Dual Antiplatelet Therapy as Appropriate Duration

Nobori Dual Antiplatelet Therapy as Appropriate Duration.

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01514227

Enrollment

3773

Registered

2012-01-23

Start date

2011-12-31

Completion date

2016-06-30

Last updated

2017-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease

Brief summary

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

Interventions

DRUGAspirin 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.

DRUGAspirin and thienopyridine

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 80 Years

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

Design outcomes

Primary

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

Secondary

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

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 9, 2026