NCT02594501Unknown不适用
COBRA PzF Stenting to Reduce the Duration of Triple Therapy in Patients Treated With Oral Anticoagulation Undergoing Percutaneous Coronary Intervention
适应症
干预措施
试验速览
- 阶段
- 不适用
- 入组人数
- 996
- 试验地点
- 48
- 主要终点
- BARC class >=2 bleeding after hospital discharge (or beyond 14 days, whichever is "later").
研究概览
简要总结
The purpose of this study is to determine whether patients undergoing coronary intervention that also require oral anticoagulation, treatment with the COBRA PzF stent plus 14-day dual anti-platelet therapy (DAPT) has higher safety and non-inferior outcomes for thrombo-embolic events than compared with standard FDA-approved drug eluting stent (DES) plus 3 or 6-month DAPT.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients older than age 18 with ischemic symptoms (stable or unstable angina or NSTEMI without thrombosis of the target lesion on coronary angiography) or evidence of myocardial ischemia in the presence of ≥ 50% de novo stenosis located in native coronary vessels (max. 2 lesions in one or 2 separate vessels).
- •Patient receiving or with an indication for new treatment with long-term oral anticoagulation with a coumadin derivatives or non-vitamin K oral anticoagulants.
- •Written, informed consent
排除标准
- •Cardiogenic shock
- •Target lesion located in left main trunk
- •Bifurcation interventions with a planned 2-stent strategy
- •Vessel size too small for implantation of a 2.5 mm stent by visual estimation
- •Patient requiring staging PCI procedure within 6 months after the index procedure
- •Patients requiring DAPT for more than 2 weeks after the index procedure
- •Contraindications or allergy to cobalt, chromium, platinum, polyzene-F, everolimus, zotarolimus or the inability to take triple therapy for at least 6 months
- •Relevant hematologic deviations: platelet count <100x10^9 cells/L or >600x10^9 cells/L
- •Active bleeding; bleeding diathesis; recent trauma or major surgery in the last month; history of intracranial bleeding or structural abnormalities; suspected aortic dissection
- •Malignancies or other co-morbid conditions with life expectancy less than 12 months or that may result in protocol non-compliance
- •Pregnancy, present (positive pregnancy test), suspected or planned, breast feeding
- •Known allergy or intolerance to the study medications: ASA, clopidogrel, coumadin and its derivatives
- •Patient's inability to fully cooperate with the study protocol
研究组 & 干预措施
COBRA PzF
Experimental
Cobra PzF plus 14-day DAPT (dual antiplatelet therapy)
干预措施: COBRA PzF (Device)
Drug Eluting Stent
Active Comparator
standard FDA-approved DES (Xience/Promus or Resolute) plus 3 or 6-month DAPT (dual anti-platelet therapy)
干预措施: Drug Eluting Stent (Device)
结局指标
主要结局
BARC class >=2 bleeding after hospital discharge (or beyond 14 days, whichever is "later").
时间窗: 6 months
Composite of all cause death, myocardial infarction, definite and probable stent thrombosis or ischemic stroke
时间窗: 6 months
次要结局
- Ischemic stroke(12 months)
- BARC class 3-5 bleeding(6 months)
- Ischemia driven target lesion revascularization(12 months)
- Composite of cardiac death and myocardial infarction(12 months)
- TIMI major bleeding; TIMI major and minor bleeding(6 months)
- Health economic utility(12 months)
- Composite of all cause death, myocardial infarction, definite and probable stent thrombosis, ischemia-driven target lesion revascularization or ischemic stroke(12 months)
- Definite and probable stent thrombosis(12 months)
- Acute Success Rates(procedure)
研究者
研究点 (48)
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