Time-trend Analysis of Clinical Characteristic and Outcomes in Patients With Unprotected Left Main Coronary Artery Disease Treated With PCI Over a 10-year Period
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 500
- 试验地点
- 2
- 主要终点
- Risk reduction of expanded MACE by TQJ230
研究概览
简要总结
Surgical coronary bypass surgery (CABG) has been demonstrated to confer significant survival benefit over medical therapies patients with LMCA in earlier clinical trials1,2,3 and therefore was the revascularization modality of choice for a long time. Recently, several randomized controlled trials and meta-analyses have shown percutaneous coronary intervention (PCI) to be non-inferior to CABG in the treatment of LMCA disease4,5,6,7,8. PCI is now considered to be an appropriate alternative to CABG for LMCA disease in patients with suitable anatomy9,10. Over recent decades, LMCA PCI has been performed in patients with increasing anatomical complexity and higher risk profiles (e.g. elderly, heart failure, renal failure etc). 11,12. In recent years, remarkable advancement in interventional techniques and technologies such as 2nd/3rd generation DES and potent antiplatelet therapy have contributed to the improvement of PCI success rates and reduction in complications and adverse events. Knowledge related to long term temporal variation of clinical and procedural characteristics and outcomes in patients with LMCA disease treated with PCI will therefore be important to inform and define future treatment strategies. This proposal aims to evaluate time-trends and regional differences in clinical characteristics and outcomes of patients with LMCA disease treated with PCI in the Asia-Pacific region
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •Lp(a) ≥ 70 mg/dL at the screening visit
- •Optimal LDL-cholesterol lowering treatment
- •Optimal treatment of other CV risk factors
- •Myocardial infarction: ≥ 3 months to ≤ 10 years prior to the screening visit, and/or
- •Ischemic stroke: ≥ 3 months to ≤ 10 years prior to the screening visit, and/or
- •Clinically significant symptomatic peripheral artery disease
排除标准
- •Uncontrolled hypertension
- •Heart failure New York Heart Association (NYHA) class IV
- •History of malignancy of any organ system
- •History of hemorrhagic stroke or other major bleeding
- •Platelet count <140,000 per μL
- •Active liver disease or hepatic dysfunction
结局指标
主要结局
Risk reduction of expanded MACE by TQJ230
时间窗: 51 months
To demonstrate the superiority of TQJ230 compared to placebo in reducing the risk of expanded MACE (cardiovascular death, non-fatal MI, non-fatal stroke and urgent coronary re-vascularization requiring hospitalization) in 1) the overall study population with established CVD (Lp(a) ≥ 70 mg/dL) and/or 2) in a subpopulation with established CVD and Lp(a) ≥ 90 mg/dL.
次要结局
- MACE reduction by TQJ230(51 months)
- coronary heart disease (CHD) outcomes by TQJ230(51 months)
研究者
Professor Bryan Ping Yen YAN
Professor
Chinese University of Hong Kong