NCT01514227已完成4 期
Nobori Dual Antiplatelet Therapy as Appropriate Duration.
Associations for Establishment of Evidence in Interventions1 个研究点 分布在 1 个国家目标入组 3,773 人开始时间: 2011年12月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 3,773
- 试验地点
- 1
- 主要终点
- Net adverse clinical and cerebral event (NACCE)
研究概览
简要总结
NIPPON trial is a prospective, randomized, trial comparing 6 and 18 months Dual Antiplatelet Therapy (DAPT) following Nobori stent deployment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects > 20 years old
- •Undergoing percutaneous intervention with Nobori deployment
- •No contraindication to prolonged DAPT
排除标准
- •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
研究组 & 干预措施
Short-term DAPT (6 months) group
Experimental
6 months DAPT (aspirin and thienopyridine) prescription following Nobori stent
干预措施: Aspirin or thienopyridine (Drug)
Long-term DAPT (18 months) group
Experimental
18 months DAPT (aspirin and thienopyridine) prescription following Nobori stent
干预措施: Aspirin and thienopyridine (Drug)
结局指标
主要结局
Net adverse clinical and cerebral event (NACCE)
时间窗: 18 months
NACCE include all-cause death, non-fatal myocardial infarction, cerebrovascular events, and major bleeding.
次要结局
- All-cause death(18 months)
- Non-fatal myocardial infarction(18 months)
- Cerebrovascular events(18 months)
- Major bleeding(18 months)
- Rate of target lesion revascularization(18 months)
- Minor bleeding(18 months)
研究者
研究点 (1)
Loading locations...
相似试验
终止
2 期
Study in Which Therapy is Either Switched to Nivolumab After 3 Months of Treatment or Therapy is Continued With a Tyrosine Kinase Inhibitor in Patients With Metastatic Renal Cell Carcinoma (RCC) and Disease ControlMetastatic Renal Cell CarcinomaNCT02959554AIO-Studien-gGmbH49
已完成
2 期
A Study to Evaluate Nivolumab in Combination With Ipilimumab Versus Pemetrexed With Cisplatin or Carboplatin for Unresectable Pleural Mesothelioma in Chinese ParticipantsMesothelioma, MalignantNCT05136677Bristol-Myers Squibb102
已完成
3 期
A Study Comparing Nivolumab, Nivolumab in Combination With Ipilimumab and Placebo in Participants With Localized Kidney Cancer Who Underwent Surgery to Remove Part of a KidneyCarcinoma, Renal CellNCT03138512Bristol-Myers Squibb1,641
已完成
3 期
Study of Nivolumab Versus Placebo in Combination With Neoadjuvant Chemotherapy and Adjuvant Endocrine Therapy in Participants With High-risk, Estrogen Receptor-Positive (ER+), Human Epidermal Growth Factor Receptor 2-Negative (HER2-) Primary Breast CancerBreast CancerNCT04109066Bristol-Myers Squibb521
已完成
2 期
Nivolumab and Ipilimumab in People With Aggressive Pituitary TumorsPituitaryPituitary CarcinomaPituitary CancerPituitary TumorNCT04042753Memorial Sloan Kettering Cancer Center10