Nobori Dual Antiplatelet Therapy as Appropriate Duration

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

Study Description

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 Design

• 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

Arms and Interventions

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.

Outcome Measures

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 ]

Eligibility Criteria

• 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

Contacts and Locations

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

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Nakamura M, Iijima R, Ako J, Shinke T, Okada H, Ito Y, Ando K, Anzai H, Tanaka H, Ueda Y, Takiuchi S, Nishida Y, Ohira H, Kawaguchi K, Kadotani M, Niinuma H, Omiya K, Morita T, Zen K, Yasaka Y, Inoue K, Ishiwata S, Ochiai M, Hamasaki T, Yokoi H; NIPPON Investigators. Dual Antiplatelet Therapy for 6 Versus 18 Months After Biodegradable Polymer Drug-Eluting Stent Implantation. JACC Cardiovasc Interv. 2017 Jun 26;10(12):1189-1198. doi: 10.1016/j.jcin.2017.04.019.

• Responsible Party: Associations for Establishment of Evidence in Interventions
• ClinicalTrials.gov Identifier: NCT01514227
• Other Study ID Numbers: NIPPON 5.0
• First Posted: January 23, 2012
• 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; Coronary Disease; Myocardial Ischemia; 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