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Nobori Dual Antiplatelet Therapy as Appropriate Duration

Information source: Associations for Establishment of Evidence in Interventions
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Coronary Artery Disease

Intervention: Aspirin or thienopyridine (Drug); Aspirin and thienopyridine (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Associations for Establishment of Evidence in Interventions

Overall contact:
Masato Nakamura, M.D., Phone: +81-3-3468-1251, Ext: 2317

Summary

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

Clinical Details

Official title: Nobori Dual Antiplatelet Therapy as Appropriate Duration.

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Net adverse clinical and cerebral event (NACCE)

Secondary outcome:

All-cause death

Non-fatal myocardial infarction

Cerebrovascular events

Major bleeding

Rate of target lesion revascularization

Minor bleeding

Eligibility

Minimum age: 20 Years. Maximum age: 80 Years. Gender(s): Both.

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

Locations and Contacts

Masato Nakamura, M.D., Phone: +81-3-3468-1251, Ext: 2317

Non-profit organization Associations for Establishment of Evidence in Interventions, Minato-ku, Tokyo 105-0013, Japan; Recruiting
Masato Nakamura, M.D., Phone: +81-3-3468-1251, Ext: 2317
Additional Information

Starting date: December 2011
Last updated: January 8, 2014

Page last updated: August 23, 2015

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