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Nobori Dual Antiplatelet Therapy as Appropriate Duration

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ClinicalTrials.gov Identifier: NCT01514227
Recruitment Status : Completed
First Posted : January 23, 2012
Last Update Posted : January 27, 2017
Sponsor:
Information provided by (Responsible Party):
Associations for Establishment of Evidence in Interventions

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

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3773 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Nobori Dual Antiplatelet Therapy as Appropriate Duration.
Study Start Date : December 2011
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Aspirin

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.




Primary Outcome Measures :
  1. 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 :
  1. All-cause death [ Time Frame: 18 months ]
  2. Non-fatal myocardial infarction [ Time Frame: 18 months ]
  3. Cerebrovascular events [ Time Frame: 18 months ]
  4. Major bleeding [ Time Frame: 18 months ]
  5. Rate of target lesion revascularization [ Time Frame: 18 months ]
  6. Minor bleeding [ Time Frame: 18 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Associations for Establishment of Evidence in Interventions
ClinicalTrials.gov Identifier: NCT01514227     History of Changes
Other Study ID Numbers: NIPPON 5.0
First Posted: January 23, 2012    Key Record Dates
Last Update Posted: January 27, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
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