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
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
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 ] [ Designated as safety issue: Yes ]
    NACCE include all-cause death, non-fatal myocardial infarction, cerebrovascular events, and major bleeding.


Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 4598
Study Start Date: December 2011
Estimated Study Completion Date: November 2018
Estimated Primary Completion Date: April 2017 (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
Genders Eligible for Study:   Both
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

Contacts
Contact: Masato Nakamura, M.D. +81-3-3468-1251 ext 2317

Locations
Japan
Non-profit organization Associations for Establishment of Evidence in Interventions Recruiting
Minato-ku, Tokyo, Japan, 105-0013
Contact: Masato Nakamura, M.D.    +81-3-3468-1251 ext 2317      
Sponsors and Collaborators
Associations for Establishment of Evidence in Interventions
  More Information

No publications provided

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 8, 2014
Health Authority: Japan: Institutional Review Board

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
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Hematologic Agents
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Central Nervous System Agents

ClinicalTrials.gov processed this record on July 28, 2014