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Nobori Dual Antiplatelet Therapy as Appropriate Duration

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Associations for Establishment of Evidence in Interventions
ClinicalTrials.gov Identifier:
NCT01514227
First received: December 22, 2011
Last updated: January 26, 2017
Last verified: January 2017
  Purpose
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.

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01514227

Locations
Japan
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
ClinicalTrials.gov 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
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Aspirin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
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

ClinicalTrials.gov processed this record on June 23, 2017