A Randomized, Controlled, Multicenter, Open-label Trial Comparing a Hospital Post-discharge Care Pathway Involving Aggressive LDL-C Management That Includes Inclisiran With Usual Care Versus Usual Care Alone in Patients With a Recent Acute Coronary Syndrome (VICTORION-INCEPTION)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 400
- 试验地点
- 88
- 主要终点
- Percent Change From Baseline to Day 330 in LDL-C
研究概览
简要总结
The purpose of this study is to study the effectiveness of implementation of a systematic LDL-C management pathway including treatment with inclisiran in participants who have experienced a recent acute coronary syndrome (ACS) and have an increased LDL-cholesterol (≥70 mg/dL) despite being treated with a statin drug.
详细描述
This was a randomized, parallel-group, open-label, multicenter, 1-year (30-day Screening Period and 330-day Treatment Period) study comparing an LDL-C management strategy including inclisiran + usual care to usual care alone. Approximately 384 participants were planned to be randomized 1:1 to aggressive LDL-C management with inclisiran + usual care (intervention arm) (3 inclisiran doses) or usual care (control arm). Usual care could have included addition of ezetimibe, bempedoic acid, PCSK9-inhibiting monoclonal antibodies, and/or commercially available inclisiran
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
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Recent Acute Coronary Syndrome (in-patient/out-patient) within 5 weeks of screening
- •Serum LDL-C ≥70 mg/dL or non-HDL-C ≥100 mg/dL
- •Fasting triglycerides <4.52 mmol/L (<400 mg/dL) at screening
- •Calculated glomerular filtration rate >20 mL/min by estimated glomerular filtration rate (eGFR)
- •Participants are required to be discharged on statin therapy, or have documented statin intolerance, as determined by the investigator, following hospitalization for an ACS. Statin intolerant participants are eligible if they had intolerable side effects on at least 2 different statins, including one at the lowest standard dose
排除标准
- •New York Heart Association (NYHA) class IIIb or IV heart failure or last known left ventricular ejection fraction <25%.
- •Significant cardiac arrhythmia within 3 months prior to randomization that is not controlled by medication or via ablation at the time of screening.
- •Severe concomitant non-cardiovascular disease that carries the risk of reducing life expectancy to less than 2 years.
- •Treatment with other investigational products or devices within 30 days or five half˗lives of the screening visit, whichever is longer.
- •Planned use of other investigational products or devices during the course of the study.
- •Treatment with monoclonal antibodies directed towards PCSK9 within 90 days of screening.
- •Recurrent ACS event within 2 weeks prior to randomization.
- •Coronary angiography and revascularization procedure (percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) surgery) performed within 2 weeks prior to the randomization visit or planned after randomization.
研究组 & 干预措施
Inclisiran with Usual Care
Inclisiran sodium 300 mg / 1.5 ml (equivalent to 284 mg of inclisiran)
干预措施: Inclisiran (Drug)
结局指标
主要结局
Percent Change From Baseline to Day 330 in LDL-C
时间窗: Baseline and Day 330
Percent change from baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Day 330
Achievement of LDL-C < 70 mg/dL at Day 330
时间窗: Day 330
Percentage of participants achieving Low-Density Lipoprotein Cholesterol (LDL-C) \< 70 mg/dL at Day 330
次要结局
- Absolute Change From Baseline in LDL-C(Baseline, Day 90, Day 270 and Day 330)
- Average Percent Change From Baseline in LDL-C Levels(Baseline, from Day 90 to Day 330)
- Average Absolute Change From Baseline in LDL-C Levels(Baseline, From Day 90 to Day 330)
- Achieving ≥50% Reduction From Baseline in LDL-C(Baseline, Day 330)
- Achieving LDL-C < 100 mg/dL and LDL-C < 55 mg/dL(Day 330)
- Percent Change in Lipids and Other Lipoproteins From Baseline to Day 330(Baseline and Day 330)
- Absolute Change in Lipids and Other Lipoproteins From Baseline to Day 330(Baseline and Day 330)
- Absolute Change in Lp[a] From Baseline to Day 330(Baseline and Day 330)
- Intensity of Lipid Lowering Therapy(Baseline and Day 330)
- Proportion of Days Covered(Baseline through last date of participation, up to 330 Days)
- Discontinuation of Statin Therapy(Baseline and Day 330)