Targeting LDL-C to Less Than 0.8 mmol/L in Patients After PCI With High Risk of Cardiovascular Disease: an Open-label, Assessor-blinded, Randomized Trial (REC-SAFETARGET Trial)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 12,000
- 试验地点
- 1
- 主要终点
- Major Adverse Cardiovascular and Cerebrovascular Events
研究概览
简要总结
Extensive evidence from epidemiological, genetic, and randomized controlled trials (RCTs) of lipid-lowering therapies has firmly established a causal relationship between low-density lipoprotein cholesterol (LDL-C) and atherosclerotic cardiovascular disease (ASCVD), establishing LDL-C as both a pathogenic risk factor and a critical therapeutic target.
Lipid-lowering therapies targeting LDL-C have significantly decreased the overall risk in ASCVD patients. Consequently, current guidelines recommend, based on risk stratification, lowering LDL-C levels in high-risk ASCVD patients to <1.4 mmol/L with a ≥50% reduction from baseline. Findings from PROVE IT-TIMI 22, IMPROVE-IT, ODYSSEY OUTCOMES, and FOURIER-OLE trials suggest that achieving extremely low LDL-C levels may further reduce the risk of cardiovascular events in ASCVD patients without substantially increasing clinically relevant adverse events; however, randomized data was still scarce in supporting this notion.
Against these backgrounds, we have designed this trial to investigate whether targeting LDL-C levels <0.8 mmol/L in high-risk ASCVD patients results in a significant reduction in adverse events compared to targeting LDL-C levels of 0.8-1.4 mmol/L.
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
- •Patients underwent percutaneous coronary intervention due to acute or chronic coronary syndrome
- •Patients with ASCVD at extremely high risk
- •Patients who are able to complete the follow-up and compliant with the allocated treatment
- •ASCVD at extremely high risk is defined as fulfilling at least TWO of the following criteria:
- •PCI for acute myocardial infarction (AMI, including STEMI or NSTEMI)
- •Previous AMI, previous stroke, or previous intervention or surgery for peripheral vascular disease
- •Experienced cardiovascular event(s) with LDL-C≤1.8mmol/L
- •LDL-C≥4.9mmol/L
- •CKD (eGFR < 60 ml/min/1.73m2)
- •Current smoking
- •Recurrent cardio/cerebrovascular events
- •History of premature ASCVD (< 55 male, < 65 female)
- •Complex PCI (fulfilling at least one of the following criteria: multivessel disease; in-stent restenosis; ≥ 3 stents implanted; total stent length ≥ 60 mm; bifurcation; left main disease; target lesions allocated in bypass graft; chronic total occlusion (≥ 3 months of occlusion))
排除标准
- •Age less than 18 years;
- •Unable to give informed consent or currently participating in other trials;
- •Patient who is pregnant or nursing (a pregnancy test must be performed within 7 days prior to randomization in women of child-bearing potential according to local practice), or plans to become pregnant during treatment;
- •Concurrent medical condition with a life expectancy of less than 3 years;
- •Hemodynamic unstable;
- •Active liver disease or hepatic dysfunction (persistent unexplained ALT/AST elevations (≥ 3 × ULN)), patients with a transient increase ALT/AST due to the acute MI may be enrolled;
- •Unable to reach the LDL-C target by known intolerance or contradiction of lipid control medications;
- •LDL-C ≤ 1.4 mmol/L at baseline without any lipid control medication lowering LDL-C;
- •Known active infection or critical hematologic/endocrine dysfunction.
研究组 & 干预措施
LDL-C target < 0.8 mmol/L
After randomization, investigators will optimize the intensive lipid-lowering regimen based on the patient's prior medication history, baseline LDL-C level, and target LDL-C level, adjusting and titrating LDL-C levels to achieve the target range.
干预措施: Intensive LDL-C control (Other)
LDL-C target of 0.8 to 1.4 mmol/L
After randomization, investigators will optimize the intensive lipid-lowering regimen based on the patient's prior medication history, baseline LDL-C level, and target LDL-C level, adjusting and titrating LDL-C levels to achieve the target range.
干预措施: Conventional LDL-C control (Other)
结局指标
主要结局
Major Adverse Cardiovascular and Cerebrovascular Events
时间窗: 24 months
MACCE, a composite of cardiovascular death, stroke, myocardial infarction, and any revascularization.
次要结局
- Stroke(24 months)
- Patient-oriented composite endpoint(24 months)
- Device-oriented Composite Endpoint(24 months)
- Composite of all-cause death, stroke, and myocardial infarction(24 months)
- All-cause death(24 months)
- Cardiovascular death(24 months)
- Myocardial infarction(24 months)
- Ischemic stroke(24 months)
- Hemorrhagic stroke(24 months)
- Revascularization(24 months)
- Target lesion revascularization(24 months)
- Cardiovascular hospitalization(24 months)
- Clinically and physiologically-indicated target lesion revascularization(24 months)
研究者
Ling Tao, MD, PhD
Professor in Cardiology, Director of the Department of Cardiology
Xijing Hospital