EUCTR2022-001876-32-DK进行中（未招募）1 期
A multi-centre, randomised, double-blind placebo-controlled, Phase 2 study to investigate efficacy, safety and tolerability of SLN360 in participants with elevated lipoprotein(a) at high risk of atherosclerotic cardiovascular disease events - ALPACAR-360
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 180
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Male or female
- •2. Aged 18 to 80 years inclusive at screening
- •3. Lipoprotein(a) at screening equal to or greater than 125 nmol/L
- •4. At high risk of ASCVD, i.e., at least one of the following conditions:
- •a) Previous MI
- •b) Coronary angiographic diagnosis of CAD with or without previous MI
- •c) Computerised tomography/magnetic resonance imaging diagnosis of CAD with or without previous MI
- •d) Previous coronary revascularisation (percutaneous coronary intervention or coronary artery bypass graft)
- •e) Prior ischeamic stroke as previously confirmed by a documented brain imaging study (e.g. CT or MRI brain), and considered not to be caused by thromboembolic phenomena associated with atrial fibrillation, valvular heart disease, or mural thrombus
- •f) Peripheral arterial disease
- •g) Existing evidence of coronary artery calcium on computerised tomography (coronary artery calcium score =1 AU)
- •5. A body mass index at screening in the range 18.0 to 32.0 kg/m2, inclusive
- •6. Participants must be able to provide valid informed consent and to comply with all study requirements
- •7. Participants receiving lipid-modifying therapy (including statins, proprotein convertase subtilisin/kexin type 9 [PCSK9] inhibitors, ezetimibe) must be on a stable, maximum tolerated regimen, according to the clinical judgement of the Investigator, at screening (i.e., receiving therapy for a minimum of 8 weeks) with no changes to existing regimens or introduction of new regimens made after screening. For monoclonal antibody PCSK9 inhibitors, a stable dose is defined as at least four doses at a consistent dose level
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 120
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 60
排除标准
- •1. Cardiovascular disease-related:
- •a. Acute cardiovascular event within the 12 weeks before screening (including but not limited to acute MI, unstable angina, percutaneous coronary intervention, coronary artery bypass graft, stroke, acute limb ischaemia, limb revascularisation)
- •b. Planned or expected cardiac surgery or coronary or other revascularisation within 12 weeks of screening or planned major non-cardiac surgery during the study period
- •2. Medical history:
- •a. Renal dysfunction with estimated glomerular filtration rate less than 30 mL/min/1.73 m2 at screening
- •b. Acute, chronic or historical liver disease, including viral hepatitis (hepatitis A, B or C virus) at screening. Participants with positive hepatitis B virus surface antibody titre reflecting hepatitis B virus immunisation are permitted to participate
- •c. Hepatic dysfunction based on liver function markers at screening: AST, ALT or total bilirubin >2 × ULN
- •d. Established diagnosis of Gilbert syndrome
- •e. Inherited or other bleeding disorders
- •f. Malignancy (except non-melanoma skin cancers, cervical in situ carcinoma, breast ductal carcinoma in situ, stage 1 prostate carcinoma, or benign tumours) within the 5 years before screening
- •g. Current or previous history of moderate to severe heart failure or last known left ventricular ejection fraction less than 30% at screening
- •h. Ventricular tachycardia, atrial fibrillation with rapid ventricular response or supraventricular tachycardia that are not controlled by medications in the 12 weeks before screening
- •i. Fasting triglycerides >400 mg/dL (4.5 mmol/L) at screening
- •j. Uncontrolled hypertension at screening
- •k. Type 1 diabetes mellitus or poorly controlled type 2 diabetes mellitus at screening
- •l. Known active infection or major haematological, renal, metabolic, gastrointestinal or endocrine dysfunction in the judgment of the Investigator at screening or Day 1
- •3. Concomitant medication:
- •a. Currently receiving or <12 weeks at Day 1 since receiving >200 mg/day niacin or niacin derivative drugs
- •b. Treatment with lipid/lipoprotein apheresis within the 12 weeks before screening
- •c. Treatment with a cholesteryl ester transfer protein inhibitor or lomitapide within the 52 weeks before screening
- •d. Treatment with aspirin, clopidogrel, ticagrelor or other antiplatelet agent unless prescribed at a low maintenance dose for the purpose of cardiovascular risk reduction
- •e. Participation in another clinical trial including an investigational medicinal product (IMP) within 12 weeks, or within five half-lives of that IMP, before screening
- •f. Any previous use of approved or experimental siRNA therapy NB: use of mRNA-based vaccines for infectious diseases is permitted
- •g. Use of approved or experimental antisense oligonucleotide therapy within the 24 weeks before screening. NB: use of mRNA-based vaccines for infectious diseases is permitted
- •h. Use of experimental Lp(a)-reducing therapy within the 52 weeks before screening
- •i. Use of herbal or complementary medicines, dietary supplements or vitamins known to substantially influence lipid metabolism or blood lipid or lipoprotein levels (e.g., fish oil, turmeric, red yeast rice) within the 4 weeks before Day 1
- •4. Alcohol and illegal drugs:
- •a. History or clinical evidence of alcohol misuse within the 26 weeks before screening
- •b. History or clinical evidence of recreational drug use within the 26 weeks before screening
- •5. Other exclusions:
- •a. Female participants of childbearing potential with a positive seru
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