Nobori Dual Antiplatelet Therapy as Appropriate Duration

Nobori Dual Antiplatelet Therapy as Appropriate Duration.

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

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Drug: Aspirin or thienopyridine; Drug: Aspirin and thienopyridine

• Study Type: Interventional
• Enrollment (Actual): 3773
• Phase: Phase 4

Contacts and Locations

Study Locations

• Japan
  • Tokyo
    • Minato-ku, Tokyo, Japan, 105-0013
      • Non-profit organization Associations for Establishment of Evidence in Interventions

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Short-term DAPT (6 months) group; 6 months DAPT (aspirin and thienopyridine) prescription following Nobori stent	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.
Experimental: Long-term DAPT (18 months) group; 18 months DAPT (aspirin and thienopyridine) prescription following Nobori stent	Drug: Aspirin and thienopyridine; Subjects randomized 18 month DAPT will be prescribed both aspirin and thienopyridine (clopidogrel or ticlopidine) for 18 month after stenting.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
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
Minor bleeding	18 months

Collaborators and Investigators

• Sponsor: Associations for Establishment of Evidence in Interventions

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: December 1, 2011
• Primary Completion (Actual): June 1, 2016
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: December 22, 2011
• First Submitted That Met QC Criteria: January 20, 2012
• First Posted (Estimate): January 23, 2012

Study Record Updates

• Last Update Posted (Estimate): January 27, 2017
• Last Update Submitted That Met QC Criteria: January 26, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Fibrinolytic Agents; Fibrin Modulating Agents; Platelet Aggregation Inhibitors; Cyclooxygenase Inhibitors; Antipyretics; Aspirin
• Other Study ID Numbers: NIPPON 5.0

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No