Short-term Effect of PCSK9 Inhibitor in Patients With Acute Ischemic Stroke

NCT06134635 | Unknown FDA Drug

• 1 other identifier: RMeng
• Study Type: observational
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a prospective cohort study to investigate the early impact of evolocumab on patients with acute ischemic stroke (AIS) in China. Evolocumab, a proprotein convertase subtilisin/kexin taye 9 inhibitor, can significantly reduce low density lipoprotein cholesterol (LDL-C) levels and has a positive effect on improving cardiovascular events. However, existing studies have focused almost exclusively on the long-term effects of Evolocumab, and the early effects of Evolocumab on AIS patients remains unclear.

Conditions

Acute Ischemic Stroke

Keywords

Acute Ischemic Stroke; Evolocumab; PCSK9 Inhibitor; Statins

Outcome Measures

Primary Outcomes (1)

• LDL-C target achievement rate on Day 5, Month 3

  LDL-C target achievement rate= Number of patients who achieved the LDL-C target level/ Total number of follow-up patients

  Day 5, Month 3

Secondary Outcomes (11)

• Percentage change in LDL-C level on Day 1, Day 3, Day 5, and Month 3

  Day 1, Day 3, Day 5, Month 3

• Percentage change in HDL-C level on Day 1, Day 3, Day 5, and Month 3

  Day 1, Day 3, Day 5, Month 3

• Percentage change in TC level on Day 1, Day 3, Day 5, and Month 3

  Day 1, Day 3, Day 5, Month 3

• Percentage change in TG level on Day 1, Day 3, Day 5, and Month 3

  Day 1, Day 3, Day 5, Month 3

• Percentage change in Apo AI level on Day 1, Day 3, Day 5, and Month 3

  Day 1, Day 3, Day 5, Month 3

Study Arms (2)

Statin-alone group

The participants in statin-alone group receive statins alone for lipid reduction.

Drug: Statins

PCSK9-i group

The participants in PCSK9-i group receive statins and evolocumab for lipid reduction.

Drug: Statins; Drug: Evolocumab

Interventions

Statins DRUG

Atorvastatin 20mg qn or rosuvastatin 10mg qn or pivastatin 2mg qn, oral

Also known as: statin therapy

PCSK9-i group; Statin-alone group

Evolocumab DRUG

Evolocumab 140mg twice a month, subcutaneous injection

Also known as: PCSK9-i

PCSK9-i group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Acute ischemic stroke patients aged 18 to 80 years

You may qualify if:

• Diagnosed with acute ischemic stroke;
• Aged 18-80 years, gender unlimited;
• The fasting LDL-C≥1.8mmol/L (70mg/dL);
• Received lipid-lowering therapy with statins with or without evolocumab;
• Premorbid mRS ≤ 2;
• NIHSS ≤ 15;
• Subjects participated in the study voluntarily and signed informed consent.

You may not qualify if:

• Participants who changed their lipid-lowering regimen;
• Participants allergic to PCSK9 inhibitors;
• Participants treated with cholesterol ester transfer protein inhibitor within 12 months prior to enrollment;
• LDL or plasma apheresis within 12 months prior to enrollment；
• Last known left ventricular ejection fraction \< 30%
• Known hemorrhagic stroke at any time；
• Severe renal dysfunction, defined as an estimated glomerular filtration rate (eGFR) \< 20 mL/min/1.73m2 at final screening；
• Active liver disease or hepatic dysfunction, defined as aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \> 3 times；
• Pregnant or lactating women；
• Severe, concomitant non-cardiovascular disease that is expected to reduce life expectancy to less than 3 years.

Sponsors & Collaborators

• Xuanwu Hospital, Beijing: lead

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Hydroxymethylglutaryl-CoA Reductase Inhibitors; evolocumab

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Anticholesteremic Agents; Hypolipidemic Agents; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Enzyme Inhibitors; Lipid Regulating Agents; Therapeutic Uses

Study Officials

• Meng Ran, PhD

  Xuanwu Hospital, Beijing

  STUDY CHAIR

Central Study Contacts

Meng Ran, PhD

CONTACT

+86-10-83199280; victor65@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2023
• First Posted: November 18, 2023
• Study Start: December 1, 2023
• Primary Completion: November 1, 2024
• Study Completion: December 1, 2024
• Last Updated: November 18, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share