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Completed

NCT Number: NCT01514227

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.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Non-profit organization Associations for Establishment of Evidence in Interventions

Minato-ku, Tokyo, 105-0013, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aspirin or thienopyridine

Drug

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.

Aspirin and thienopyridine

Drug

Subjects randomized 18 month DAPT will be prescribed both aspirin and thienopyridine (clopidogrel or ticlopidine) for 18 month after stenting.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Associations for Establishment of Evidence in Interventions

Other

Registry information

Official study title

Nobori Dual Antiplatelet Therapy as Appropriate Duration.

Important dates

Study start
2011
Primary completion
2016
Study completion
2016
First posted
Jan 23, 2012
Registry last updated
Jan 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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