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
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Condition or disease | Intervention/treatment | Phase |
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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 |
Arm | Intervention/treatment |
---|---|
Experimental: Short-term DAPT (6 months) group
6 months DAPT (aspirin and thienopyridine) prescription following Nobori stent
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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
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Drug: Aspirin and thienopyridine
Subjects randomized 18 month DAPT will be prescribed both aspirin and thienopyridine (clopidogrel or ticlopidine) for 18 month after stenting. |
- 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.
- All-cause death [ Time Frame: 18 months ]
- Non-fatal myocardial infarction [ Time Frame: 18 months ]
- Cerebrovascular events [ Time Frame: 18 months ]
- Major bleeding [ Time Frame: 18 months ]
- Rate of target lesion revascularization [ Time Frame: 18 months ]
- Minor bleeding [ Time Frame: 18 months ]

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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 |
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

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
Japan | |
Non-profit organization Associations for Establishment of Evidence in Interventions | |
Minato-ku, Tokyo, Japan, 105-0013 |
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 Key Record Dates |
Last Update Posted: | January 27, 2017 |
Last Verified: | January 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
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 |