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Nobori Dual Antiplatelet Therapy as Appropriate Duration

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01514227
First Posted: January 23, 2012
Last Update Posted: January 27, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Associations for Establishment of Evidence in Interventions
December 22, 2011
January 23, 2012
January 27, 2017
December 2011
June 2016   (Final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01514227 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Coronary Artery Disease
  • 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.
  • Drug: Aspirin and thienopyridine
    Subjects randomized 18 month DAPT will be prescribed both aspirin and thienopyridine (clopidogrel or ticlopidine) for 18 month after stenting.
  • Experimental: Short-term DAPT (6 months) group
    6 months DAPT (aspirin and thienopyridine) prescription following Nobori stent
    Intervention: Drug: Aspirin or thienopyridine
  • Experimental: Long-term DAPT (18 months) group
    18 months DAPT (aspirin and thienopyridine) prescription following Nobori stent
    Intervention: Drug: Aspirin and thienopyridine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
3773
June 2016
June 2016   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
20 Years to 80 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
 
NCT01514227
NIPPON 5.0
No
Not Provided
Plan to Share IPD: No
Associations for Establishment of Evidence in Interventions
Associations for Establishment of Evidence in Interventions
Not Provided
Not Provided
Associations for Establishment of Evidence in Interventions
January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP