NCT07684469尚未招募4 期
Comparative, Randomized, Multicenter, Followed by an Open Label Extension Trial in Patients With a Recent Acute Coronary Syndrome Evaluating the Early Inclusion of Inclisiran Into Standard of Care Versus Standard of Care Alone in Kingdom of Saudi Arabia
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 300
- 主要终点
- Percent change in LDL-C from baseline at Day 60
研究概览
简要总结
This study aims to evaluate the effectiveness and safety of implementing a systematic augmented low-density lipoprotein cholesterol (LDL-C) management care pathway initiated in hospitals for patients with Acute Coronary Syndrome. This pathway includes treatment with inclisiran on top of the standard of care (SOC), which consists of statins with or without ezetimibe, compared to a high-intensity SOC regimen alone (statins +/- ezetimibe).
详细描述
This multi-center phase IV study adopted a two-phase design. The first phase (Day 1 to Day 90) is an open-label, randomized, comparative parallel-group design comparing an LDL-C management strategy that includes inclisiran with SOC versus SOC alone. The second phase is an open-label extension design (Day 90 to Day 210). After the EOI visit, the participants from phase 2 will be invited to participate in a 1-year long-term observational phase to assess medication adherence and satisfaction.
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
- •Participants eligible for inclusion in this study must meet all of the following criteria:
- •Males and females ≥18 years of age.
- •Recent ACS (in-patient/out-patient) within 7 days of index admission, as per 2023 ESC guidelines for the management of acute coronary syndrome
- •Serum LDL-C ≥1.8 mmol/L (≥70 mg/dL) or non-HDL ≥100 mg/dL at screening for participants who were receiving SOC [including lipid lowering therapy and/or ezetimibe] prior enrollment.
- •Serum LDL-C ≥2.6 mmol/L (≥100 mg/dL) or non-HDL ≥124 mg/dL at screening for participants who were SOC treatment naïve prior enrollment.
- •Fasting triglycerides <4.52 mmol/L (<400 mg/dL) at screening.
- •Estimated glomerular filtration rate (eGFR) >30 mL/min at screening.
- •Participants must be willing and able to give informed consent before initiation of any study related procedures and willing to comply with all required study procedures.
排除标准
- •Participants meeting any of the following criteria are not eligible for inclusion in this study:
- •Any uncontrolled or serious disease, or any medical or surgical condition, that may either interfere with participation in the clinical study and/or put the participant at significant risk (according to investigator's [or delegate] judgment) if he/she participates in the clinical study.
- •An underlying known disease, or surgical, physical, or medical condition that, in the opinion of the investigator (or delegate) might interfere with interpretation of the clinical study results.
- •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.
- •Uncontrolled severe hypertension: systolic blood pressure >180 mmHg or diastolic blood pressure >110 mmHg prior to randomization (assessed at screening visit) despite antihypertensive therapy.
- •Homozygous familial hypercholesterolemia (HoFH) defined as LDL-C ≥ 12 mmol/L.
- •Statin intolerant patients defined as documented side effects on 2 different statins, including one at the lowest standard dose.
- •Severe concomitant non-cardiovascular disease that carries the risk of reducing life expectancy to less than 2 years.
- •History of malignancy that required surgery (excluding local and wide-local excision), radiation therapy and/or systemic therapy during the three years prior to randomization.
- •Women of childbearing potential, defined as all women physiologically capable of becoming pregnant from menarche until becoming post-menopausal, unless they have had surgical bilateral oophorectomy (with or without hysterectomy), total hysterectomy or bilateral salpingectomy at least six weeks before taking study treatment. In the case of oophorectomy alone, the reproductive status of the woman needs to have been confirmed by follow-up hormone level assessment. Women are considered post-menopausal if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g., hormonal profile confirming menopause and/or age-appropriate history of vasomotor symptoms).
- •Breastfeeding women.
- •Treatment with other investigational products or devices within 30 days or five half-lives of the screening visit, whichever is longer.
- •History of hypersensitivity to any of the study treatments or its excipients, or to drugs of similar chemical classes (statins, ezetimibe, and inclisiran).
- •Planned use of other investigational products or devices during the course of the study.
- •Any condition that, according to the investigator, could interfere with the conduct of the study, such as but not limited to:
- •Participants who are unable to communicate or to cooperate with the investigator.
- •Unable to understand the protocol requirements, instructions and study-related restrictions, the nature, scope, and possible consequences of the study (including participants whose cooperation is doubtful due to drug abuse or alcohol dependency).
- •Unlikely to comply with the protocol requirements, instructions, and study-related restrictions (e.g., uncooperative attitude, inability to return for follow-up visits, and improbability of completing the study).
- •Persons directly involved in the conduct of the study.
- •Treatment with monoclonal antibodies directed towards PCSK9 or inclisiran within 60 days of screening or planned use of it as SOC during next 210 days.
- •Active liver disease defined as any known current infectious, neoplastic, or metabolic pathology of the liver or (ii) alanine aminotransferase (ALT) elevation >3x ULN, aspartate aminotransferase (AST) elevation >3x ULN, or total bilirubin elevation >2x ULN (except patients with Gilbert's syndrome) at screening confirmed by a repeat measurement at least one week apart.
- •Uncontrolled Diabetes Mellitus (DM) defined as HbA1c > 9%.
- •Other protocol-defined inclusion/exclusion criteria may apply
结局指标
主要结局
Percent change in LDL-C from baseline at Day 60
时间窗: Baseline and Day 60
Difference in percent change from baseline in Low-Density Lipoprotein Cholesterol (LDL-C) between inclisiran + SOC group and SOC alone group
次要结局
- Absolute change from baseline in LDL-C levels(Baseline, Day 14, Day 30, Day 60, Day 90 in phase 1 and Day 150 in phase 2)
- Average percent change from baseline in LDL-C levels(Baseline, Day 14, Day 30, Day 60, Day 90 in phase 1 and Day 150 in phase 2)
- Average absolute change from baseline in LDL-C levels(Baseline, Day 14, Day 30, Day 60, Day 90 in phase 1 and Day 150 in phase 2)
- Proportion of participants achieving LDL-C levels <1.4 mmol/L(Day 30, Day 60, Day 90 in phase 1 and Day 150 in phase 2)
- Proportion of participants achieving LDL-C levels <1.8 mmol/L(Day 30, Day 60, Day 90 in phase 1 and Day 150 in phase 2)
- Absolute change from baseline in VLDL, non-HDL-C, TC, HDL-C and TG(Baseline and Day 90)
- Absolute change from baseline in Lp(a)(Baseline and Day 90)
- Proportion of participants needing additional lipid lowering therapy(Day 90 in phase 1 and Day 150 in phase 2)
- Average percent change in LDL-C levels(Between Day 30 and Day 90 in phase 1 and Day 150 in phase 2)
- Average absolute change in LDL-C levels(Between Day 30 and Day 90 in phase 1 and Day 150 in phase 2)
- Proportion of participants achieving a target LDL-C level <1.4 mmol/L(Day 210)
- Proportion of participants achieving a target LDL-C level <1.8 mmol/L(Day 210)
- Average percent change from baseline in LDL-C levels(Day 210)
- Average absolute change from baseline in LDL-C levels(Day 210)
- Number of participants with AEs and SAEs(Up to 210 days)
- Mean score in the Treatment Satisfaction Questionnaire for Medication (TSQMII)(Day 210)
研究者
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