Trials
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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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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