Further Lipid-Lowering With PCSK9 Inhibitors for Cardiovascular Outcomes in High-Risk Coronary Plaques Assessed by CT Angiography
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 3,596
- 试验地点
- 6
- 主要终点
- Major adverse cardiac and cerebrovascular events (MACCEs)
研究概览
简要总结
The primary objective was to evaluate the effect of PCSK9 inhibitors in addition to the background lipid-modifying therapy (LMT), compared with standard LMT in terms of clinical outcomes in patients with coronary CT angiography (CCTA)-detected high-risk plaques.
详细描述
CCTA is an accurate, noninvasive alternative to invasive coronary angiography. CCTA can provide detailed information about the characteristics of coronary artery plaques, such as their composition, morphology, and distribution. Various CCTA-detected plaque characteristics indicative of plaque quantity and quality have been identified as high-risk features independently predicting clinical events, including the presence of positive remodeling, low attenuation plaque, spotty calcification, and napkin ring sign. Currently, the treatment for CCTA-detected high-risk plaque has been receiving increasing interest. The current study aimed to prove the efficacy of PCSK9 inhibitors in addition to the background LMT, as compared with standard LMT in patients with CCTA-detected high-risk plaques.
Hypothesis
PCSK9 inhibitors in addition to background LMT will show a superior event rate, compared with standard LMT, in terms of major adverse cardiac and cerebrovascular events (MACCEs) at 24 months after the last patient's randomization in patients with high-risk coronary plaques assessed by CT Angiography.
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 (Outcomes Assessor)
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
- •Subject must be ≥ 18 years.
- •Patients with at least one target lesion meet CCTA-detected plaque features of the following:
- •Degree of stenosis ≥ 50% or plaque burden ≥ 70%
- •At least 2 of the following high-risk plaque features:
- •i. Low-attenuation plaque ii. Positive remodeling iii. Napkin-ring sign iv. Spotty calcium
- •The target lesion is located at the proximal or mid segment of left anterior descending artery, left circumflex artery or right coronary artery.
- •Subject is able to confirm his/her understanding of the risks, benefits, and treatment alternatives of receiving study-related treatment. He/she or his/her legally authorized representative provides written informed consent prior to any study-related procedure.
排除标准
- •Target lesions underwent or planned to revascularization.
- •Patients with acute coronary syndrome.
- •New York Heart Association class III or IV, or last known left ventricular ejection fraction < 30%.
- •Uncontrolled or recurrent ventricular tachycardia.
- •Homozygous familial hypercholesterolemia.
- •Active liver disease or hepatic dysfunction.
- •Failed CCTA plaque analysis.
- •Non-cardiac co-morbid conditions with life expectancy < 2 years.
- •Pregnant and/or lactating women.
- •Known hypersensitivity or contraindication to statin or PCSK9 inhibitors.
研究组 & 干预措施
Standard lipid-modifying therapy
Patients will receive standard LMT commonly used in clinical practice.
干预措施: Standard lipid-modifying therapy (Drug)
PCSK9 inhibitors plus background lipid-modifying therapy
Patients will receive PCSK9 inhibitors treatment and background lipid-modifying therapy for the first 12 months after randomization, and then continue background lipid-modifying therapy for the remainder of the trial.
结局指标
主要结局
Major adverse cardiac and cerebrovascular events (MACCEs)
时间窗: 24 months after the last patient's randomization
A composite of death from any cause, myocardial infarction (MI), coronary revascularization, or stroke.
次要结局
- All-cause and cardiac death.(24 and 60 months after the last patient's randomization)
- MACCEs(60 months after the last patient's randomization)
- Individual component of MACCEs.(24 and 60 months after the last patient's randomization)
- Major adverse cardiovascular events (MACEs)(24 and 60 months after the last patient's randomization)
- Target vessel failure (TVF)(24 and 60 months after the last patient's randomization)
- Cost-effectiveness analysis(24 and 60 months after the last patient's randomization)
- Any target-vessel MI.(24 and 60 months after the last patient's randomization)
- Any target vessel revascularization.(24 and 60 months after the last patient's randomization)
- Any coronary revascularization (ischemia-driven or all).(24 and 60 months after the last patient's randomization)
- CT coronary angiography findings(36 months after the last patient's randomization)