Nobori Dual Antiplatelet Therapy as Appropriate Duration

Coronary Artery Disease Clinical Trial

Official title:

Nobori Dual Antiplatelet Therapy as Appropriate Duration.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01514227
• Other study ID #: NIPPON 5.0
• Status: Completed
• Phase: Phase 4
• First received: December 22, 2011
• Last updated: January 26, 2017
• Start date: December 2011
• Est. completion date: June 2016

Study information

• Verified date: January 2017
• Source: Associations for Establishment of Evidence in Interventions
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3773
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

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

Locations

Country	Name	City	State
Japan	Non-profit organization Associations for Establishment of Evidence in Interventions	Minato-ku	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Associations for Establishment of Evidence in Interventions

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Net adverse clinical and cerebral event (NACCE)	NACCE include all-cause death, non-fatal myocardial infarction, cerebrovascular events, and major bleeding.	18 months
Secondary	All-cause death		18 months
Secondary	Non-fatal myocardial infarction		18 months
Secondary	Cerebrovascular events		18 months
Secondary	Major bleeding		18 months
Secondary	Rate of target lesion revascularization		18 months
Secondary	Minor bleeding		18 months