EUCTR2021-003759-40-DE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
相关药物
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 at least one of 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 at least one the following:
- •? Markedly elevated single risk factors, in particular total cholesterol >310 mg/dL, LDL-C > 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 ==55mg/dL
- •? in participants with high cardiovascular risk: serum LDL-C ==70mg/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 at screening and
- •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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