Outcome of Second Generation Drug-eLuting Stents in Patients With Diabetes Mellitus (OCELOT)
Outcome of seCond Generation Drug-ELuting Stents in Patients With Diabetes Mellitus: cOmparison of Three differenT Drug Regimens
Design: prospective, randomized, multi-center trial comparing the safety and efficacy in the prevention of target lesion failure (TLF) of second generation paclitaxel- versus ABT578- versus Everolimus- eluting stents Study Population: all consecutive diabetic patients with de novo coronary artery lesions undergoing drug-eluting stent implantation in 2010-12.
Time Course: initial Enrollment: October 2010; end of the Enrollment: December 2012 Primary End-Point: target lesion revascularization (TLF) defined as the occurrence of cardiac death, myocardial infarction and repeated lesion revascularization within 12 months.
Secondary End-Points: 1) impact of glucose level during the first three months following the procedure (assessed by hemoglobin A1C ) on clinically-driven target lesion revascularization; 2)TLF and TLR within 12, 24 and 36 months; 3) comparison 12 months versus prolonged (> 12 months) of dual antiplatelet therapy
研究概览
详细说明
研究类型
阶段
- 第四阶段
联系人和位置
学习地点
-
-
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Modena、意大利、41100
- Azienda Policlinico-Universitaria di Modena
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Rome、意大利、00100
- Policlinico Casilino
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-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Subject is > 18 years old
- Presence of one or more de novo stenosis equal or greater than 70% in a native coronary artery, treated with a second generation drug-eluting stent
- Subject and the treating physician agree that the subject will comply with all follow-up evaluations
- Subject has been informed of the nature of the study and agrees to its provisions and has provided written informed consent as approved by the Institutional Review Board/Ethics Committee of the respective clinical site
Exclusion Criteria:
- Subject's age is < 18 years and with acute myocardial infarction in the 48 prior to the procedure
- The patient is pregnant or breastfeeding
- Known allergies to: aspirin, clopidogrel (Plavix) and ticlopidine (tiklid), heparin, Paclitaxel, Everolimus, ABT 578, stainless steel, or contrast agent (which cannot be adequately pre-medicated)
- A platelet count < 75,000 cells/mm3 or > 700,000 cells/mm3 or a WBC < 3,000 cells/mm3
- Subject is currently participating in an investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the current study endpoints
- Prior participation in this study
- Active peptic ulcer or upper GI bleeding within the prior 3 months
- Subject has active sepsis
- Any lesion that is located in a saphenous vein graft
- In the investigator's opinion, subject has a co-morbid condition(s) that could limit the life expectancy to less than one year, or limit the subject's ability to participate in the study or comply with follow-up requirements or impact the scientific integrity of the study
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器:Taxus Element
Patients treated with paclitaxel-eluting stent (Taxus Element, Boston Scientific, MN)
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paclitaxel-eluting stent
其他名称:
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有源比较器:Xience Prime
Patients treated with Everolimus-eluting stent (Xience Prime, Abbott, IL)
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Everolimus-eluting stent
其他名称:
|
|
有源比较器:Integrity Resolute
Patients treated with ABT 578-eluting stent (Integrity Resolute, Medtronic, MA)
|
ABT 578-eluting stent
其他名称:
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Target lesion failure
大体时间:1 year
|
Target lesion failure (TLF) defined as the occurrence of cardiac death, target vessel-related myocardial infarction and repeated revascularization of the target lesion
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1 year
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Effect of glucose levels on repeat revascularization
大体时间:1 year
|
Impact of glucose level during the three months following the procedure (assessed by hemoglobin A1C ) on clinically-driven target lesion revascularization rate
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1 year
|
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Target Lesion Revascularization
大体时间:1, 2 and 3 year
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Target lesion revascularization at 12, 24 and 36 months
|
1, 2 and 3 year
|
|
Effect of dual antiplatelet therapy on outcome
大体时间:3 year
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Comparison of 12-month versus prolonged (> 12-month) dual antiplatelet therapy on outcome
|
3 year
|
合作者和调查者
调查人员
- 首席研究员:Enrico Romagnoli, MD, PhD、Policlinico Casilino
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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