Optimal Duration of DAPT Following Treatment With Endeavor (Zotarolimus-eluting Stent) in Real-world Japanese Patients: A Prospective Multicenter Registry (OPERA)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,187
- 试验地点
- 112
- 主要终点
- NACCE (Net adverse clinical and cerebral event)
研究概览
简要总结
A prospective multicenter registry in real-world Japanese patients undergoing DAPT for three months after stenting. To assess the long-term safety of Endeavor Zotarolimus-eluting stent through noninferiority in the primary endpoint between two different continuous regimen (three and twelve months) groups of DAPT after stenting with Endeavor Zotarolimus-eluting stent in real-world Japanese patients and to examine the optimal duration of DAPT after stenting with Endeavor Zotarolimus-eluting stent. The long-term DAPT group in the present clinical study (to be appropriated from the post-marketing surveillance of Endeavor) should consist of consecutive patients undergoing DAPT for twelve months after stenting, while the short-term DAPT group (to be newly registered in the present clinical study) should consist of patients who are instructed to undergo DAPT for three months after stenting.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical inclusion criteria
- •Patient over age 20 years.
- •Patient who is clinically indicated for PCI by stenting at least in one coronary lesion that is visually confirmed by coronary angiography.
- •Patient who has agreed to conditions after receiving an explanation about the contents of the present clinical study and who has signed the consent form approved by the ethical review board at each study site.
- •Patient who has agreed to undergo all clinical FUs listed in the present protocol.
- •Coronary angiographic inclusion criteria:
- •Patient who has a > 50% occlusion or stenosis that is visually confirmed by coronary angiography in a native coronary artery > 2.5 mm in diameter and in whom the relevant coronary artery has an anatomical structure that is eligible for PCI with Endeavor Zotarolimus-eluting stent.
排除标准
- •Clinical exclusion criteria
- •Patient over age 85 years.
- •Patient with ST elevation MI who requires primary or rescue PCI and whose performance status falls under any of the exclusion criteria.
- •Patient with cardiogenic shock.
- •Patient who underwent stent treatment with BMS in other lesions within 6 months prior to the conduct of index PCI of the target vessel.
- •Patient who has undergone some treatment with DES for coronary lesions.
- •Patient who is scheduled to undergo elective surgery within 12 months after index PCI.
- •Patient whose left ventricular ejection fraction (LVEF) is < 40%.
- •Patient with a hemorrhagic predisposition or a history of coagulation abnormality
- •Patient in whom the total number of deployed stents exceeds 4,regardless of the number of lesions and the number of affected branches.
- •Patient with a verified history of CVA before stenting.
- •Patient with a verified history of active peptic ulcer or upper gastrointestinal tract bleeding before Stenting.
- •Patient showing impaired renal function. (serum creatinine concentration: > 1.8 mg/dL)
- •Patient with known contraindications for aspirin or clopidogrel. (the physician should assess tolerability within the range of routine medical care)
- •Patient with a known disorder who has a life expectancy of less than 12 months.
- •Patient who is incompetent to adhere to all clinical FUs listed in the present protocol.
- •Angiographic exclusion criteria:
- •Lesions located within the saphenous venin graft (SVG).
- •Unprotected lesions in the left coronary trunk.
- •Lesions of in-stent restenosis in previously deployed DES or BMS.
- •Lesions with an anatomical structure of the coronary artery that is not eligible for treatment by the deployment of Endeavor ZES.
研究组 & 干预措施
Short-term DAPT group
1,200 patients to be newly registered: Undergo 3-month (+ 30 days) DAPT (aspirin and clopidogrel)
干预措施: Clopidogrel (Drug)
结局指标
主要结局
NACCE (Net adverse clinical and cerebral event)
时间窗: 12 months
NACCE is defined as a composite endpoint consisting of death from some causes (including cardiac death and noncardiac death), myocardial infarction (Q-wave MI and non-Q wave MI), cerebral vascular accident, and major bleeding (as per the modified version of REPLACE-2 criteria for bleeding and as per GUSTO criteria for bleeding).
次要结局
- Stent thrombosis(12 months)
- MACE (major adverse cardiac events)(1, 3, 6, 9 and 12 months)
- TVR (target vessel revascularization)(9 and 12 months)
- DAPT compliance(12 months)
- TLR (target lesion revascularization)(9 and 12 months)
- Hemorrhagic complications(12 months)