Trials
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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GAUSS-2
Trial GAUSS-2 (The Goal Achievement after Utilizing an anti-PCSK9 antibody in Statin Intolerant Subjects trial) Aim To evaluate the efficacy and safety of subcutaneous (SC) evolocumab compared with oral ezetimibe in hypercholesterolaemic subjects unable to tolerate effective statin doses Study design Randomised, double-blind, placebo-controlled phase…
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GAUSS-3
Trial GAUSS-3Goal Achievement After Utilizing an Anti-PCSK9 Antibody in Statin Intolerant Subjects-3 A Double-blind, Randomized, Multicenter Study to Evaluate the Safety and Efficacy of Evolocumab, Compared With Ezetimibe, in Hypercholesterolemic Subjects Unable to Tolerate an Effective Dose of a HMG-CoA Reductase Inhibitor Due to Muscle…
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GAUSS-4
Trial GAUSS-4: Goal Achievement After Utilizing an Anti-PCSK9 Antibody in Statin Intolerant Subjects-4 ClinicalTrials.gov Identifier: NCT02634580 Aim To evaluate the safety and efficacy of evolocumab, compared with ezetimibe, in hypercholesterolemic Japanese subjects unable to tolerate an effective dose of statin due to muscle related side…
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GLAGOV
Trial GLAGOV (GLobal Assessment of Plaque reGression With a PCSK9 antibOdy as Measured by intraVascular Ultrasound (Ongoing study) Aim To evaluate whether LDL-C lowering with evolocumab results in greater change from baseline in percentage atheroma volume (PAV) at week 78 than placebo in subjects with…
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HAUSER-OLE
Evolocumab Study title: HAUSER-OLE Open Label Study to Evaluate Safety, Tolerability and Efficacy of Evolocumab (AMG 145) in Pediatric Subjects (10 to 17 Years of Age) With Heterozygous Familial Hypercholesterolemia (HeFH) or Homozygous Familial Hypercholesterolemia (HoFH). ClinicalTrials.gov Identifier: NCT02624869 Aim To describe the safety and…
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HAUSER-RCT
Trial HAUSER-RCT: Trial Assessing Efficacy, Safety and Tolerability of PCSK9 Inhibition in Paediatric Subjects With Genetic LDL Disorders ClinicalTrials.gov Identifier: NCT02392559 Aim To assess the safety and efficacy of evolocumab in paediatric subjects aged 10-17 years diagnosed with heterozygous familial hypercholesterolemia (FH) Study design…
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HUYGENS
Trial High-Resolution Assessment of Coronary Plaques in a Global Evolocumab Randomized Study (HUYGENS) (NCT03570697) Aim To evaluate the impact of PCSK9 inhibition with evolocumab on coronary atheroma phenotype. The primary objective is to evaluate the effect of evolocumab on changes in fibrous cap thickness (FCT)…
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LAPLACE-2
Trial LAPLACE-2 (The Low-density Lipoprotein Cholesterol Assessment With PCSK9 Monoclonal Antibody Inhibition Combined With Statin Therapy – 2 Trial) Aim To evaluate evolocumab in statin-treated subjects with primary hypercholesterolaemia and mixed dyslipidaemia. Study design Phase 3, double-blind, randomised placebo and ezetimibe controlled multicentre study Patient…
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