Effect of High-intensity Statin With Ezetimibe COmbination theRapy Versus High-intensity sTatin Monotherapy After Percutaneous Coronary Intervention With Drug-eluting Stents; the ESCORT Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 4,310
- 试验地点
- 1
- 主要终点
- Clinical efficacy of lipid lowering therapy
研究概览
简要总结
This study sought to evaluate whether ezetimibe combination to high-intensity statin therapy will have more prominent beneficial effect compared to high-intensity statin monotherapy in patients who underwent coronary revascularization with newer generation drug-eluting stent (DES) implantation. Furthermore, the optimal OCT-based optimal expansion criteria as well as the efficacy and safety of newer generation will be investigated.
详细描述
All eligible patients who underwent coronary revascularization with newer generation DES implantation will be enrolled according to inclusion/exclusion criteria after voluntary agreement with informed consent. At the time of enrollment, we will stratify the patients according to LDL-cholesterol <100mg/dL, acute coronary syndrome, and DES type, and randomly assign them in two groups according to lipid-lowering therapy with a 1:1 ratio: "Combination therapy group" vs. "Statin monotherapy group". In this study, four types of new generation DES will be used: Orsiro (Biotronik), Firehawk (Microport), Genoss (Genoss) or D+Storm (CGBIO).
In this study, OCT substudy will be performed for the patients with diffuse long lesions requiring total stented length ≥30 mm (targeted for 700 patients in the trial). Corresponding patients will be randomly assigned into two groups according to the OCT-based optimal expansion criteria with a 1:1 ratio: meeting "Absolute expansion" vs. "Relative expansion". The absolute expansion criteria is defined as a minimum stent area (MSA) >4.5mm2, while the relative expansion criteria is defined as achieving an MSA ≥ 80% of the mean reference lumen area or ≥ 100% of the distal reference lumen area. The patients will receive DES implantation under OCT guidance and stent optimization will be performed to satisfy the assigned expansion criteria.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 19-85 years
- •Patients who underwent coronary revascularization with newer generation DES implantation
排除标准
- •Allergy or hypersensitive to ezetimibe or statin
- •Active liver disease or persistent unexplained serum AST/ALT elevation more than 2 times the upper limit of normal range
- •History of any adverse drug reaction requiring discontinuation of statin
- •Pregnant women, women with potential childbearing, or lactating women
- •Life expectancy less than 3 years
- •Inability to follow the patient over the period of 1 year after enrollment, as assessed by the investigator
- •Inability to understand or read the informed consent
研究组 & 干预措施
Combination therapy group
Ezetimibe/high-intensity statin combination therapy
干预措施: ezetimibe/high-intensity statin combination therapy (ezetimibe 10mg plus atoravastatin 40mg) (Drug)
Statin monotherapy group
High-intensity statin monotherapy
干预措施: high-intensity statin monotherapy (atoravastatin 40mg) (Drug)
结局指标
主要结局
Clinical efficacy of lipid lowering therapy
时间窗: Within 3 years after the enrollment
Composite of all-cause death, myocardial infarction (MI), any coronary revascularization, hospitalization for unstable angina, or nonfatal stroke within 3 years
次要结局
- Each component of primary endpoint D. Hospitalization for unstable angina (percentage)(Within 3 years after the enrollment)
- Each component of primary endpoint E. Nonfatal-stroke (percentage)(Within 3 years after the enrollment)
- Cardiac death (percentage)(Within 3 years after the enrollment)
- Target-vessel revascularization (percentage)(Within 3 years after the enrollment)
- Proportion of subjects achieving target LDL-cholesterol <55 mg/dL or 70 mg/dL at 6 weeks, 1, 2, and, 3 years(Within 3 years after the enrollment)
- Target-lesion revascularization (percentage)(Within 3 years after the enrollment)
- Device-oriented composite endpoint which is composite of cardiovascular death, MI, or clinically-driven target-vessel revascularization (percentage)(Within 3 years after the enrollment)
- Each component of primary endpoint A. All-cause death (percentage)(Within 3 years after the enrollment)
- Difference in high-ischemic risks (percentage)(Within 3 years after the enrollment)
- different OCT optimization criteria when treating very long lesions(Within 3 years after the enrollment)
- Each component of primary endpoint B. MI (percentage)(Within 3 years after the enrollment)
- Stent thrombosis (percentage)(Within 3 years after the enrollment)
- BARC type 2-5 bleeding (percentage)(Within 3 years after the enrollment)
- BARC type 3-5 bleeding (percentage)(Within 3 years after the enrollment)
- Patient-oriented composite endpoint which is composite of all-cause death, MI, or any coronary revascularization (percentage)(Within 3 years after the enrollment)
- Rate of cross-over into the non-allocated therapy(Within 3 years after the enrollment)
- Each component of primary endpoint C. Any coronary revascularization (percentage)(Within 3 years after the enrollment)
- Difference in antiplatelet therapy strategy (percentage)(Within 3 years after the enrollment)
- Difference in high-bleeding risks (percentage)(Within 3 years after the enrollment)
- Safety endpoint related to lipid-lowering medication(Within 3 years after the enrollment)