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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)

Rosuvastatin and Evolocumab for Coronary Artery Disease

Completed
Conditions
Coronary Artery Disease
Interventions
First Posted Date
2023-08-09
Last Posted Date
2023-08-09
Lead Sponsor
Icahn School of Medicine at Mount Sinai
Target Recruit Count
195
Registration Number
NCT05984953
Locations
🇺🇸

Mount Sinai Hospital, New York, New York, United States

Study on the Composite Endpoint Event of PCSK9 Inhibitor in Patients With Very High Risk of ASCVD and Cancer

Phase 4
Not yet recruiting
Conditions
Cancer
ASCVD
Atherosclerotic Cardiovascular Disease
Proprotein Convertase Subtilisin/Kexin Type 9 Inhibitor
Interventions
First Posted Date
2023-08-04
Last Posted Date
2023-08-04
Lead Sponsor
Xiang Xie
Target Recruit Count
620
Registration Number
NCT05976893

In Silico Study Assessing the Impact of Inclisiran on Major Adverse Cardiovascular Events in Patients With Established Cardiovascular Disease

Completed
Conditions
Atherosclerotic Cardiovascular Disease
Interventions
First Posted Date
2023-08-03
Last Posted Date
2024-05-08
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
204691
Registration Number
NCT05974345
Locations
🇫🇷

Novartis Investigative Site, Rueil-Malmaison, France

Effect of PCSK9 Inhibitor on Retinal Microvessels in Patients With Coronary Heart Disease After Intensive Lipid-lowering Therapy

Phase 4
Recruiting
Conditions
Adverse Effect of Cardiovascular Medications (Diagnosis)
Interventions
First Posted Date
2023-04-06
Last Posted Date
2023-04-06
Lead Sponsor
Zibo Central Hospital
Target Recruit Count
60
Registration Number
NCT05802108
Locations
🇨🇳

Zibo Central Hospital, Zibo, Shandong, China

Evolocumab Added to Statin Therapy in Symptomatic Intracranial Atherosclerotic Stenosis (EAST-ICAS)

Phase 3
Recruiting
Conditions
Stroke Patients With Symptomatic Intracranial Atherosclerotic Stenosis
Interventions
First Posted Date
2023-02-23
Last Posted Date
2023-06-02
Lead Sponsor
The First Affiliated Hospital with Nanjing Medical University
Target Recruit Count
80
Registration Number
NCT05741086
Locations
🇨🇳

the First affiliated hospital of Nanjing Medical University, Nanjing, Jiangsu, China

Safety and Efficacy of Evolocumab in Ischemic Stroke

Phase 4
Not yet recruiting
Conditions
Ischemic Stroke, Acute
Interventions
First Posted Date
2023-01-25
Last Posted Date
2023-01-25
Lead Sponsor
Second Affiliated Hospital of Guangxi Medical University
Target Recruit Count
200
Registration Number
NCT05697185

Effect of Early Initiation of Evolocumab on Lipid Profiles Changes in Patients With ACS Undergoing PCI

Phase 4
Completed
Conditions
Low-Density-Lipoprotein-Type [LDL] Hyperlipoproteinemia
Interventions
First Posted Date
2022-12-22
Last Posted Date
2025-03-13
Lead Sponsor
Yonsei University
Target Recruit Count
108
Registration Number
NCT05661552
Locations
🇰🇷

Yongcheol Kim, Yongin, Gyeonggi-do, Korea, Republic of

Cholesterol Lowering and Residual Risk in Diabetes, Type 1

Phase 4
Recruiting
Conditions
Type 1 Diabetes
Interventions
Device: Angiocatheter 20IV
Device: J-Wire
Device: GlycoCheck Glycocalyx Measurement Software
First Posted Date
2022-12-08
Last Posted Date
2025-03-03
Lead Sponsor
NYU Langone Health
Target Recruit Count
125
Registration Number
NCT05641753
Locations
🇺🇸

New York VA Hospital, New York, New York, United States

🇺🇸

NYC Health + Hospitals/Bellevue, New York, New York, United States

🇺🇸

Mount Sinai School of Medicine, New York, New York, United States

and more 1 locations

Effect of Very Early and Rapid Lowering Cholesterol With Evolocumab on Left Ventricular Remodeling in Patients With Anterior STEMI Undergoing Primary PCI

Phase 4
Recruiting
Conditions
ST Elevation Myocardial Infarction (STEMI)
Interventions
First Posted Date
2022-11-14
Last Posted Date
2025-03-25
Lead Sponsor
Henan Institute of Cardiovascular Epidemiology
Target Recruit Count
330
Registration Number
NCT05613426
Locations
🇨🇳

The People's Hospital of Changyuan, Xinxiang, Henan, China

🇨🇳

Hopeshine Minsheng Hospital of Xinzheng, Xinzheng, Henan, China

🇨🇳

The People's Hospital of Xuchang, Xuchang, Henan, China

and more 3 locations

High-Resolution Assessment of Extracranial Plaques in a Multiple Centers Evolocumab Randomized Study

Phase 4
Recruiting
Conditions
Cerebral Atherosclerosis
Interventions
Drug: Intensive statin treatment
First Posted Date
2022-10-18
Last Posted Date
2023-12-11
Lead Sponsor
Wuhan Union Hospital, China
Target Recruit Count
200
Registration Number
NCT05585151
Locations
🇨🇳

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China

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