EUCTR2021-003759-40-ES进行中（未招募）1 期
Efficacy, safety, tolerability and quality of life of ongoing individually optimized? lipid-lowering therapy with or without inclisiran (KJX839) – a randomized, placebo-controlled, double-blind multicenter phase IV study in participants with hypercholesterolemia
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,760
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
- •Male or female participants >/= 18 years of age.
- •Participants meeting one of the following CV category:
- •Very high risk participants with the following:
- •-Documented Atherosclerotic cardiovascular disease (ASCVD)
- •i. Acute coronary syndrome: Unstable angina or myocardial infarction.
- •ii. Stable angina.
- •iii. Coronary revascularization.
- •iv. Unequivocally documented ASCVD upon prior imaging.
- •v. Stroke and TIA.
- •vi. Peripheral artery disease (PAD).
- •- Diabetes mellitus (DM) with target organ damage (defined as microalbuminuria, retinopathy, or neuropathy), or at least >/= 3 major risk factors, or early onset of Type 1 DM of long duration (> 20 years).
- •- A calculated SCORE2 >/= 7.5% for age < 50 years; SCORE2 >/= 10% for age 50-69 years; SCORE2-OP >/= 15% for age >/= 70 years to estimate 10-year risk of fatal and non-fatal cardiovascular disease (CVD).
- •- Pre-existing diagnosis of heterozygous familial hypercholesterolemia (HeFH) with ASCVD or with another major risk factor.
- •High risk participants with the following:
- •- Markedly elevated single risk factors, in particular total cholesterol > 8mmol/L (>310 mg/dL), LDL-C > 4.9 mmol/dL (> 190 mg/dL), or blood pressure >/= 180/110 mmHg
- •- Pre-existing diagnosis of HeFH without other major risk factors.
- •- Diabetes Mellitus (DM) without target organ damage (defined as microalbuminuria, retinopathy, or neuropathy), with DM duration >/= 10 years or other additional risk factor.
- •- Moderate chronic kidney disease (eGFR 30-59 mL/min/1.73m2).
- •- A calculated SCORE2 2.5 to <7.5% for age < 50 years, SCORE2 5 to < 10% for age 50-69 years; SCORE2-OP 7.5 to < 15% for age >/= 70 years to estimate 10-year risk of fatal and non-fatal CVD.
- •LDL-C levels at screening and baseline:
- •- in participants with very high cardiovascular risk: serum LDL-C >/= 1.4 mmol/l (>/= 55 mg/dL).
- •- in participants with high cardiovascular risk: serum LDL-C >/= 1.8 mmol/l (>/= 70 mg/dL).
- •Participant on a stable dose of a statin for >/= 30 days at screening.
- •Participants on the individual MTD of statin for >/= 30 days at baseline.
- •Fasting triglyceride < 400 mg/dL (< 4.52 mmol/L) at screening and baseline.
- •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 792
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 968
排除标准
- •Participants on more than one other lipid-lowering drug on top of statin at screening visit.
- •Participants with a known intolerance to rosuvastatin at screening or baseline visit.
- •Previous (within 90 days of screening), current or planned treatment with a monoclonal antibody (mAb) directed towards PCSK9 (e.g. evolocumab, alirocumab) at screening or baseline visit.
- •Previous exposure to inclisiran or any other non-mAb PCSK9 targeted therapy, either as an investigational or marketed drug within 2 years prior to screening or baseline visit.
- •Previous, current or planned treatment with LDL-apheresis at screening or baseline visit.
- •Liver and CK: (a) Active liver disease defined as any current infectious, neoplastic, or metabolic pathology of the liver or (b) unexplained alanine aminotransferase (ALT), aspartate aminotransferase (AST) elevation >3x ULN, or total bilirubin elevation > 2x ULN (except for participants with Gilbert's syndrome), or (c) creatine kinase (CK) >5x ULN at screening or baseline visit.
- •Participant with severe renal impairment defined by eGFR < 30 mL/min/1.73m2 as calculated by the Modification in Diet in Renal Disease (MDRD) formula at screening or baseline visit.
- •Acute coronary syndrome, ischemic stroke or TIA, coronary revascularization or peripheral arterial revascularization procedure or amputation due to atherosclerotic disease < 3 months prior to the screening or baseline visit.
- •Heart failure New York Heart Association (NYHA) class IV at screening or baseline visit
- •Pregnant or nursing (lactating) women at screening or baseline visit.
- •Women of child-bearing potential, unless they are using highly effective methods of contraception during dosing of study treatment.
研究者
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