Comparison of Bio-Active-Stent to the Everolimus-Eluting Stent in Acute Coronary Syndrome (A Prospective, Randomized and a Multicenter Clinical Study)
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 825
- 试验地点
- 8
- 主要终点
- The primary end point (MACE) is the composite of cardiac death, myocardial infarction (MI) and target lesion revascularization (TLR) during 12 months of follow-up.
研究概览
简要总结
The purpose of the trial is to compare the safety and effectiveness of bio-active-stent (BAS) and everolimus-eluting stent (EES) in patients presenting with acute coronary syndrome.
详细描述
The BASE-ACS trial is an academic study, which will be conceived and conducted as a multicenter (multi-country) study by experienced interventional cardiologists. This study is independent of commercial interests.
The purpose of the trial is to compare the safety and effectiveness of bio-active-stent (Titan-2®) and everolimus-eluting stent (Xience V®, Promus®) in patients presenting with acute coronary syndrome.
A total of 850 patients will be included in the randomized study. The primary end point (MACE) is the composite of cardiac death, myocardial infarction and target lesion revascularization during 12 months of follow-up. Enrollment of patients will start in November 2008 and end in 2009.
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
- Single (Participant)
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
- •All patients presenting with acute coronary syndrome (unstable angina, non-st-elevation myocardial infarction or st-elevation myocardial infarction)and undergoing percutaneous coronary intervention
- •Written informed consent
排除标准
- •Age < 18 years
- •Expected survival < 1 year
- •Allergy to aspirin, clopidogrel or ticlopidine
- •Allergy to heparins, glycoprotein IIb/IIIa inhibitors or bivalirudin
- •Allergy to everolimus
- •Active bleeding or significant increased risk of bleeding
- •Stent length longer than 28 mm needed
- •Stent diameter > 4.0 mm needed
- •Thrombolysis therapy
- •Planned surgery within 12 months of PCI unless the dual antiplatelet therapy could be maintained throughout the perisurgical period
结局指标
主要结局
The primary end point (MACE) is the composite of cardiac death, myocardial infarction (MI) and target lesion revascularization (TLR) during 12 months of follow-up.
时间窗: 12 months
次要结局
- All cause death, cardiac death, MI, stent thrombosis and TLR at 1, 6, 12 and 18 months, and at 2, 3, 4 and 5 years.(5 years)