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Evolocumab

Generic Name
Evolocumab
Brand Names
Repatha
Drug Type
Biotech
CAS Number
1256937-27-5
Unique Ingredient Identifier
LKC0U3A8NJ
Background

Evolocumab is a monoclonal antibody designed for the treatment of hyperlipidemia by Amgen. It is a subcutaneous injection approved by the FDA for individuals on maximum statin therapy who still require additional LDL-cholesterol lowering. It is approved for both homozygous and heterozygous familial cholesterolemia as an adjunct to other first-line therapies. Evolocumab is a human IgG2 monoclonal antibody that targets the proprotein convertase subtilisin/kexin type 9 (PCSK9). PCSK9 is a protein that targets LDL receptors for degradation, therefore reducing the liver's ability to remove LDL-cholesterol (LDL-C), or "bad" cholesterol, from the blood. Evolocumab is designed to bind to PCSK9 and inhibit PCSK9 from binding to LDL receptors on the liver surface, resulting in more LDL receptors on the surface of the liver to remove LDL-C from the blood. Evolocumab is the second PCSK9 inhibitor on the market, first being alirocumab.

Indication

Evolocumab is indicated in adult patients with established cardiovascular disease to reduce the risk of myocardial infarction, stroke, and coronary revascularization. It is also indicated as an adjunct to diet, alone or in combination with other hypolipidemic treatments, in adults with primary hyperlipidemia (and in pediatric patients ≥10 years old with heterozygous familial hypercholesterolemia) to reduce LDL-C. In addition, it is indicated adjunctly to other hypolipidemic treatments in patients ≥10 years old with homozygous familiar hypercholesterolemia to reduce LDL-C.

Associated Conditions
Coronary Revascularization, Myocardial Infarction, Stroke, Increases in serum total low-density lipoprotein (LDL)

A Study of Evolocumab on Carotid Artery Atherosclerotic Plaque Morphology Prior to Carotid EndArterectomy

Phase 4
Conditions
Carotid Artery Stenosis
Asymptomatic Carotid Artery Stenosis
Interventions
First Posted Date
2020-09-04
Last Posted Date
2022-05-02
Lead Sponsor
Canadian Medical and Surgical Knowledge Translation Research Group
Target Recruit Count
60
Registration Number
NCT04539223
Locations
🇨🇦

North York Diagnostic and Cardiac Centre, North York, Ontario, Canada

🇨🇦

St. Michael's Hospital, Toronto, Ontario, Canada

🇨🇦

East Toronto Vascular Clinic, Toronto, Ontario, Canada

Evolocumab In Advanced Chronic Kidney Disease Trial

Phase 4
Withdrawn
Conditions
Chronic Kidney Diseases
High Cholesterol
Interventions
Other: Placebo
First Posted Date
2020-08-12
Last Posted Date
2022-07-28
Lead Sponsor
NYU Langone Health
Registration Number
NCT04510844
Locations
🇺🇸

NYU Langone Nephrology Associates - Long Island, Mineola, New York, United States

🇺🇸

NYU Langone Health, New York, New York, United States

Evolocumab Plus Ezetimibe in High Risk Haemodialized Statin Intolerant Patients

Phase 4
Conditions
Chronic Kidney Disease Requiring Chronic Dialysis
Hypercholesterolemia
Interventions
First Posted Date
2020-05-21
Last Posted Date
2020-05-26
Lead Sponsor
Policlinico Casilino ASL RMB
Target Recruit Count
50
Registration Number
NCT04397653
Locations
🇮🇹

Policlinico Casilino, Rome, Italy

Impact of PCSK9 Inhibitors on Coronary Microvascular Dysfunction in Patients With Atherosclerotic Cardiovascular Disease Proved by Myocardial Ischemia and Needing Coronarography

Phase 2
Conditions
Atherosclerotic Cardiovascular Disease
Interventions
First Posted Date
2020-04-08
Last Posted Date
2022-05-19
Lead Sponsor
University Hospital, Grenoble
Target Recruit Count
66
Registration Number
NCT04338165
Locations
🇫🇷

Grenoble University Hospital, Grenoble, France

Subclinical Atherosclerosis in Patients With Familial Hypercholesterolemia Treated With Evolocumab®

Recruiting
Conditions
Hypercholesterolemia, Familial
Interventions
First Posted Date
2020-03-18
Last Posted Date
2021-03-08
Lead Sponsor
Federico II University
Target Recruit Count
25
Registration Number
NCT04313270
Locations
🇮🇹

Matteo Di Minno, Napoli, Italy

Effect of Evolocumab in Patients With Critical Limb Ischemia (Evol-CLI)

Phase 4
Conditions
Critical Limb Ischemia
Interventions
Other: Placebo 1 milliliter (mL) Injector Pen x 3 monthly for 12 months
First Posted Date
2020-03-13
Last Posted Date
2020-03-13
Lead Sponsor
Leonardo Clavijo
Target Recruit Count
32
Registration Number
NCT04306471
Locations
🇺🇸

University of Southern California, Los Angeles, California, United States

Effect of Evolocumab in Functional Status and LDL Oxidation of Patients With Peripheral Arterial Disease

Phase 4
Conditions
Peripheral Arterial Disease
Interventions
Other: Placebo 1milliliter (mL) Subcutaneous Injection pre-filled injector Pen x 3 monthly for 6 months.
First Posted Date
2020-03-12
Last Posted Date
2020-03-12
Lead Sponsor
Leonardo Clavijo
Target Recruit Count
86
Registration Number
NCT04306081
Locations
🇺🇸

University of Southern California, Los Angeles, California, United States

Early Treatment With Evolocumab in Patients With ST-elevation Myocardial Infarction

Phase 2
Withdrawn
Conditions
ST-elevation Myocardial Infarction
Interventions
First Posted Date
2020-03-11
Last Posted Date
2024-11-21
Lead Sponsor
Fondazione IRCCS Policlinico San Matteo di Pavia
Registration Number
NCT04303377
Locations
🇮🇹

IRCCS Policlinico San Matteo, Pavia, PV, Italy

Functional Improvement of Coronary Artery Narrowing by Cholesterol Reduction With a PCSK9 Antibody

Not Applicable
Completed
Conditions
Coronary Artery Disease
Atherosclerosis of Coronary Artery
Interventions
First Posted Date
2019-10-28
Last Posted Date
2024-07-18
Lead Sponsor
Radboud University Medical Center
Target Recruit Count
150
Registration Number
NCT04141579
Locations
🇳🇱

Radboud University Medical Center, Nijmegen, Gelderland, Netherlands

PCSK9 Inhibitor Treatment for Patients With SPG5

Phase 1
Conditions
Hereditary Spastic Paraplegia Type 5
Interventions
First Posted Date
2019-09-24
Last Posted Date
2021-11-23
Lead Sponsor
First Affiliated Hospital of Fujian Medical University
Target Recruit Count
30
Registration Number
NCT04101643
Locations
🇨🇳

Department of Neurology , First Affiliated Hospital Fujian Medical University, Fuzhou, China

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