Outcome of seCond Generation Drug-ELuting Stents in Patients With Diabetes Mellitus: cOmparison of Three differenT Drug Regimens
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 发起方
- 试验地点
- 4
- 主要终点
- Target lesion failure
研究概览
简要总结
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
详细描述
Prospective, randomized, triple arm study. The study population will include all consecutive diabetic patients within 24 months undergoing elective second generation DES implantation for de novo coronary artery disease. In the randomization process all participating centers will be equally stratified to avoid statistical unbalance.
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
- •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
排除标准
- •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
研究组 & 干预措施
Taxus Element
Patients treated with paclitaxel-eluting stent (Taxus Element, Boston Scientific, MN)
干预措施: Taxus Element stent (Device)
Xience Prime
Patients treated with Everolimus-eluting stent (Xience Prime, Abbott, IL)
干预措施: Xience Prime stent (Device)
Integrity Resolute
Patients treated with ABT 578-eluting stent (Integrity Resolute, Medtronic, MA)
干预措施: Integrity Resolute stent (Device)
结局指标
主要结局
Target lesion failure
时间窗: 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
次要结局
- Effect of glucose levels on repeat revascularization(1 year)
- Target Lesion Revascularization(1, 2 and 3 year)
- Effect of dual antiplatelet therapy on outcome(3 year)