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Nobori Dual Antiplatelet Therapy as Appropriate Duration

This study has been completed.
Information provided by (Responsible Party):
Associations for Establishment of Evidence in Interventions Identifier:
First received: December 22, 2011
Last updated: January 26, 2017
Last verified: January 2017
NIPPON trial is a prospective, randomized, trial comparing 6 and 18 months Dual Antiplatelet Therapy (DAPT) following Nobori stent deployment.

Condition Intervention Phase
Coronary Artery Disease
Drug: Aspirin or thienopyridine
Drug: Aspirin and thienopyridine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: Nobori Dual Antiplatelet Therapy as Appropriate Duration.

Resource links provided by NLM:

Further study details as provided by Associations for Establishment of Evidence in Interventions:

Primary Outcome Measures:
  • Net adverse clinical and cerebral event (NACCE) [ Time Frame: 18 months ]
    NACCE include all-cause death, non-fatal myocardial infarction, cerebrovascular events, and major bleeding.

Secondary Outcome Measures:
  • All-cause death [ Time Frame: 18 months ]
  • Non-fatal myocardial infarction [ Time Frame: 18 months ]
  • Cerebrovascular events [ Time Frame: 18 months ]
  • Major bleeding [ Time Frame: 18 months ]
  • Rate of target lesion revascularization [ Time Frame: 18 months ]
  • Minor bleeding [ Time Frame: 18 months ]

Enrollment: 3773
Study Start Date: December 2011
Study Completion Date: June 2016
Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.


Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01514227

Non-profit organization Associations for Establishment of Evidence in Interventions
Minato-ku, Tokyo, Japan, 105-0013
Sponsors and Collaborators
Associations for Establishment of Evidence in Interventions
  More Information

Responsible Party: Associations for Establishment of Evidence in Interventions Identifier: NCT01514227     History of Changes
Other Study ID Numbers: NIPPON 5.0
Study First Received: December 22, 2011
Last Updated: January 26, 2017
Individual Participant Data  
Plan to Share IPD: No

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics processed this record on May 25, 2017