2025-521670-34-00招募中3 期
A randomized, double-blind, placebo-controlled study to evaluate efficacy and safety of early in hospital initiation of inclisiran treatment in patients with acute coronary syndromes: Victorion – RIDES
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 24
- 试验地点
- 5
- 主要终点
- Percent change in LDL-C from baseline to Day 150
研究概览
简要总结
To demonstrate the superiority of inclisiran treatment compared to placebo, when initiated before/at discharge, in combination with SoC (statin therapy +/- LLT or non-statin treatment in case of documented statin intolerance) on LDL-C reduction at Day 150
研究设计
- 分配方式
- Randomized
- 主要目的
- Assess efficacy/safety of in hospital start of inclisiran in patients with acute coronary syndromes
- 盲法
- Double (Subject, Monitor, Carer, Analyst, Investigator)
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Signed informed consent must be obtained prior to participation in the study.
- •Males and females, ≥18 years of age at the time of providing written informed consent.
- •Ability to understand the study's requirements and provide informed consent and comply with all required study procedures.
- •Hospitalization for an ACS event (STEMI or NSTEMI).
- •Receiving treatment for the qualifying ACS event, according to clinical judgement, by means of medical treatment alone or percutaneous coronary revascularization.
- •Had a successful PCI (with or without stent) for the qualifying event, if PCI is required.
- •LDL-C value at the Screening visit measured by the local lab of: • LDL-C ≥70 mg/dL in participant previously treated with high-intensity statin (atorvastatin ≥40 mg/day or rosuvastatin ≥20 mg/day) or equivalent as per national guidelines and local regulation for at least 4 weeks before screening or • LDL-C ≥100 mg/dL in participant previously treated with low/moderate-intensity statin for at least 4 weeks before screening or • LDL-C ≥125 mg/dL in participant previously not treated with statins for at least 4 weeks before screening, or who never received statins (including statin intolerant participants).
- •The participant must have a Baseline fasting LDL-C ≥70 mg/dL (local lab assessment) to be eligible for randomization.
- •Randomization within 7 days (≤ 7 days) following hospital admission for the qualifying ACS event and before/at discharge.
排除标准
- •Participant who is clinically unstable during hospitalization for the qualifying ACS event, defined by any of the following events within 24 hours prior to randomization: • Hemodynamic instability: hypotension, defined as sustained systolic blood pressure of <90 mmHg due to cardiac failure with associated symptoms requiring inotropes • Arrhythmic events: Ventricular storm (e.g., torsade, ventricular tachycardia, ventricular flutter) • Cardiogenic shock or mechanical complication of myocardial infarction • New York Heart Association (NYHA) class IV heart failure • Left ventricular ejection fraction <20% at randomization (after all treatment procedures, based on the latest assessment of the LVEF using invasive or non-invasive assessment modalities) • Uncontrolled severe hypertension: systolic blood pressure >180 mmHg or diastolic blood pressure >110 mmHg prior to randomization despite antihypertensive therapy.
- •Ongoing or medical history of myopathy at the Screening visit.
- •CK values ≥5x ULN at Screening visit and confirmed by repeat test during Screening (local lab), in the context of an ACS, and assessed as related to the index event and/or treatment procedures (such as PCI) eligibility will be based on Investigator’s judgement for participant who will be randomized (who will be switched to or initiated on the protocol-specified dose of high-intensity statin of atorvastatin ≥40 mg QD or rosuvastatin ≥20 mg QD). Unless a more stringent CK value threshold is mandated by a local regulatory authority (e.g., ≥3x ULN in Korea according to MFDS internal guideline).
- •Participant who has undergone or is scheduled to undergo CABG for treatment of the qualifying ACS event.
- •Active liver disease defined as: (i) any known current infectious, neoplastic, or metabolic pathology of the liver or (ii) ALT elevation >3x ULN, or AST elevation >3x ULN, or total bilirubin elevation >2x ULN (except participant with Gilbert’s syndrome) at the Screening visit, in the context of an ACS, and assessed as related to the index event and/or treatment procedures (such as PCI). Eligibility will be based on Investigator’s judgement for participant who will be randomized.
- •Renal insufficiency (eGFR <30 mL/min/1.73m2) at the Screening visit.
- •Fasting triglycerides value >400 mg/dL (4.52 mmol/L; assessed by local labs) at randomization visit.
- •Participant, who based on the Investigator's judgement, could reach the LDL-C target value of <55 mg/dL after 4 weeks on statin treatment only.
- •Secondary hypercholesterolemia (based on medical history).
- •Homozygous familial hypercholesterolemia (based on medical history).
- •Participant on apheresis at Screening visit.
结局指标
主要结局
Percent change in LDL-C from baseline to Day 150
Percent change in LDL-C from baseline to Day 150
次要结局
- • Participants achieving LDL-C <70 mg/dL (yes, no) at Day 150 • Participants achieving LDL-C <55 mg/dL (yes, no) at Day 150 • Participants achieving LDL-C <100 mg/dL (yes, no) (among the subset of participants with LDL-C ≥100 mg/dL at baseline) at Day 150 • Participants achieving ≥50% reduction from baseline in LDL-C (yes, no) at Day 150
- • Percent change from baseline to mean LDL-C over the double-blind treatment period (averaged over all post-baseline visits) • Absolute change from baseline to mean LDL-C over the double-blind treatment period (averaged over all post-baseline visits) • Percent change in LDL-C from baseline to Day 30 and Day 90 • Absolute change in LDL-C from baseline to Day 30, Day 90 and Day 150
- Percent change and absolute change in PCSK9 from baseline to Day 30, Day 90 and Day 150
- Percent change and absolute change from baseline in: apoB, VLDL, non-HDLC, HDL-C, total cholesterol and triglycerides at Day 150
- Number and percentage of participants experiencing treatment emergent AEs or SAEs
研究者
Novartis Pharma Arzneimittel GmbH
Scientific
Novartis Pharma AG
研究点 (5)
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