Evolocumab
ANITSCHKOW
Trial ANITSCHKOW: Effects of Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) Inhibition on Arterial Wall Inflamation Study in Patients With Elevated Lipoprotein(a) (Lp(a)). ClinicalTrials.gov Identifier: NCT02729025 Aim To assess the effects of PCSK9 inhibition on the arterial wall inflammation in patients with elevated Lp(a) Study design…
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BANTING
Trial EvolocumaB efficAcy aNd safeTy IN type 2 diabetes mellitus on backGround statin therapy (BANTING) Type 2 diabetes with hypercholesterolaemia/mixed dyslipidaemia: NCT02739984 Aim To evaluate the effect of a 12-week regimen of monthly subcutaneous treatment with evolocumab 420 mg versus placebo, on low-density lipoprotein cholesterol…
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BEIJERINCK
Trial BEIJERINCK: A Double Blind, Randomized, Placebo Controlled, Multicenter Study to Evaluate Safety, Tolerability, and Efficacy on LDL-C of Evolocumab (AMG 145) in Subjects With HIV and With Hyperlipidemia and/or Mixed Dyslipidemia. ClinicalTrials.gov Identifier: NCT02833844 Aim To investigate the efficacy and safety of evolocumab (420…
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BERSON
Trial Type 2 diabetes with hyperlipidaemia/mixed dyslipidaemia: BERSON A double-blind, randomized study in diabetic subjects with hyperlipidaemia or mixed dyslipidaemia ClinicalTrials.gov Identifier: NCT02662569 Key results 986 patients (mean age 61.3 years, 43% male) were enrolled and randomized to placebo 2-weekly (n=166); placebo monthly (n=161); evolocumab…
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CARUSO
Trial CARUSO (CARotid plaqUe StabilizatiOn and Regression With Evolocumab) ClinicalTrials.gov Identifier: NCT04730973 Aim To investigate the efficacy of evolocumab in promoting carotid plaque morphological stabilization and regression versus traditional lipid lowering therapy. Study design Randomized, single-centre, investigator-initiated trial. Patients will be randomized to evolocumab 140…
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CHORD
CHORD Trial CHOlesterol Lowering and Residual Risk in Type 2 Diabetes (CHORD) ClinicalTrials.gov Identifier: NCT04369664 Aim To investigate why individuals with type 2 diabetes are at increased risk for heart disease and stroke. This study will investigate risk factors for heart disease and stroke, including…
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DE LAVAL
Trial DE LAVAL: A Randomized, Actively Controlled, Open-label, Multicenter Study of Efficacy and Safety of Evolocumab Compared With Low Density Lipoprotein Cholesterol (LDL-C) Apheresis, Followed by Single-Arm Evolocumab Administration in Subjects Receiving LDL-C Apheresis Prior to Study Enrollment. ClinicalTrials.gov Identifier: NCT02585895 Aim To evaluate the…
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DESCARTES
Trial DESCARTES (Durable Effect of PCSK9 Antibody Compared with Placebo Study) Aim To evaluate the safety and efficacy of 52 weeks’ treatment with evolocumab 420 mg s.c. (every 4 weeks) versus placebo Study design Randomised, double-blind, placebo-controlled phase 3 trial Patient population Adults aged…
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EBBINGHAUS
Trial EBBINGHAUS (Evaluating PCSK9 Binding antiBody Influence oN coGnitive HeAlth in High cardiovascUlar Risk Subjects); [Substudy of FOURIER] Aim To evaluate change over time in neurocognitive testing in subjects receiving statin therapy in combination with evolocumab versus statin plus placebo. Study design Double-Blind, Placebo…
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EVACS
Trial Evolocumab in Acute Coronary Syndrome (EVACS) ClinicalTrials.gov Identifier: NCT03515304 Aim To evaluate 1) low-density lipoprotein cholesterol (LDL-C) reduction during hospitalization and at 30 days, (2) changes in vascular/plaque and myocardial inflammation at 30 days, (3) serum markers of endothelial function at hospital discharge and…
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EVOCATION
Trial EVOCATION (jRCTs051180022) Aim To evaluate whether pre-treatment with evolocumab could decrease the index of microvascular resistance (IMR) after percutaneous coronary intervention (PCI) in patients with stable coronary artery disease (CAD). Study design Multicentre, randomized, open-label, active-controlled, parallel-group, exploratory, investigator-initiated clinical study. Patients will be…
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Evol-CLI
Trial Effect of Evolocumab in Patients With Critical Limb Ischemia (Evol-CLI) ClinicalTrials.gov Identifier: NCT04369664 Aim To investigate the effect of evolocumab in patients with CLI on maximally tolerated lipid lowering therapy with a statin for one year after an index CLI event, requiring revascularization Study…
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Evolocumab: effect on lipoprotein particles
Trial Evolocumab: effect on lipoprotein particles and subclasses in heterozygous familial hypercholesterolaemia (HeFH) Aim To evaluate the effect of evolocumab on LDL, VLDL, and HDL particles (LDL-P, VLDL-P, HDL-P), size, and subclass cholesterol content in hypercholesterolaemic and HeFH subjects Study design The study used exploratory…
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Evolocumab vs. LDL apheresis
Trial Evolocumab vs. LDL apheresis: Trial assessing evolocumab compared to LDL-C apheresis in subjects receiving LDL-C apheresis prior to study enrollment ClinicalTrials.gov Identifier: NCT02585895 Aim To evaluate the efficacy of evolocumab, compared to regularly scheduled LDL apheresis, on reducing the need for future apheresis Study…
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EVOLVD
Title EVOLVD:Cholesterol Lowering With EVOLocumab to Prevent Cardiac Allograft Vasculopathy in De-novo Heart Transplant Recipients ClinicalTrials.gov Identifier: NCT03734211 Aim To test whether treatment with evolocumab can ameliorate cardiac allograft vasculopathy in heart transplant recipients Study design Randomized, double-blind trial. Eligible patients were randomized 1:1 to…
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EVOPACS
Trial EVOlocumab for Early Reduction of LDL-cholesterol Levels in Patients With Acute Coronary Syndromes (EVOPACS) ClinicalTrials.gov Identifier: NCT03287609 Aim To evaluate the safety and effectiveness of evolocumab versus placebo, administered in the acute phase of ACS, for reduction of low-density lipoprotein cholesterol (LDL-C levels) within…
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FLOREY
Trial FLOREY (Effects on Lipoprotein Metabolism From PCSK9 Inhibition Utilizing a Monoclonal Antibody) Aim To evaluate the effect of evolocumab, atorvastatin, and combination therapy on lipoprotein kinetics. Study design Double-blind, Randomized, Placebo-controlled, Single Site Study Patient population Primary hyperlipidaemia and mixed dyslipidaemia Primary efficacy endpoint…
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FOURIER
Trial FOURIER (Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With Elevated Risk) Aim To assess the effect of additional LDL-C lowering with evolocumab when used in addition to other treatment for dyslipidaemia on outcomes including cardiovascular death, myocardial infarction, hospitalization for unstable…
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FOURIER-OLE
Trial Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With Elevated Risk Open-label Extension (FOURIER OLE) ClinicalTrials.gov Identifier: NCT02867813 Aim To evaluate the long-term safety of evolocumab in subjects with established atherosclerotic cardiovascular disease (ASCVD) who completed FOURIER Study design Multicentre, open-label extension study…
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GAUSS
Trial GAUSS (Goal Achievement After Utilizing an Anti-PCSK9 Antibody in Statin Intolerant Subjects) study Aim To assess the efficacy and tolerability of evolocumab in patients with statin intolerance due to muscle-related side effects. Study design A 12-week, randomised, double-blind, placebo- and ezetimibe-controlled, phase 2 dose-ranging…
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