NCT04087915Unknown不适用
A Perspective, Cohort Study Assessing the Impact of Additional LDL-Cholesterol Reduction on Major Cardiovascular Events When Evolocumab is Used in Combination With Statin Therapy In Patients With High Risk Cardiovascular Disease
Beijing Anzhen Hospital1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2019年9月11日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Occurrence of main adverse cardiovascular and cerebrovascular events (MACCE)
研究概览
简要总结
The primary objective was to evaluate the effect of treatment with evolocumab on the risk for cardiovascular death, myocardial infarction, stroke, hospitalization for unstable angina, or coronary revascularization, whichever occurs first, in patients with high risk coronary artery disease.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Male or female ≥ 18 years of age
- •Coronary artery disease at high risk (Syntax Score ≥ 33)
- •Patients had to have a fasting LDL cholesterol level of 1.4 mmol per liter while they had been taken an optimized regimen of lipid-lowering therapy for at least 4 weeks, which was defined as preferably a high intensity statin but must have been at least atorvastatin at a dose of 20 mg daily or its equivalent, with or without ezetimibe.
排除标准
- •New York Heart Association (NYHA) class III or IV, or last known left ventricular ejection fraction < 30%
- •Uncontrolled hypertension
- •Uncontrolled or recurrent ventricular tachycardia
- •Untreated hyperthyroidism or hypothyroidism
- •Homozygous familial hypercholesterolemia
- •LDL or plasma apheresis
研究组 & 干预措施
High risk coronary artery disease
Participants with high risk coronary artery disease.
干预措施: Evolocumab (Drug)
结局指标
主要结局
Occurrence of main adverse cardiovascular and cerebrovascular events (MACCE)
时间窗: 1 year
MACCE will include all-cause death, cardiovascular death, myocardial infarction, hospitalization for unstable angina, stroke, or coronary revascularization
次要结局
- Reduction in LDL-C(up to 12 months)
研究者
Yujie Zhou
PhD,MD
Beijing Anzhen Hospital
研究点 (1)
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