Nobori Dual Antiplatelet Therapy as Appropriate Duration

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Associations for Establishment of Evidence in Interventions
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 8, 2014
Last verified: January 2014

December 22, 2011
January 8, 2014
December 2011
April 2017   (final data collection date for primary outcome measure)
Net adverse clinical and cerebral event (NACCE) [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: Yes ]
  • Non-fatal myocardial infarction [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
  • Cerebrovascular events [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
  • Major bleeding [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
  • Rate of target lesion revascularization [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
  • Minor bleeding [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.
 
Recruiting
4598
November 2018
April 2017   (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
Both
20 Years to 80 Years
No
Contact: Masato Nakamura, M.D. +81-3-3468-1251 ext 2317
Japan
 
NCT01514227
NIPPON 5.0
Not Provided
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 2014

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