Stroke Clinical Trials

Find Stroke Clinical Trials Near You

Efficacy and Safety of PCSK9 Inhibitors in Patients With Large-Artery Atherosclerosis (LAA) Ischemic Stroke: A Prospective Multicenter Cohort Study

Status: Recruiting
Location: See location...
Study Type: Observational
SUMMARY

This prospective multicenter cohort study aims to evaluate the effectiveness and safety of early PCSK9 inhibitor therapy in patients with large-artery atherosclerotic ischemic stroke. The study will compare early neurological improvement, lipid-lowering effect, 90-day functional outcome, recurrent cardio-cerebrovascular events, and safety outcomes between patients treated with evolocumab plus statin and those treated with statin alone.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• Age 18-80 years.

• Acute ischemic stroke diagnosed according to the Chinese Guidelines for Diagnosis and Treatment of Acute Ischemic Stroke (2023), based on clinical and imaging criteria.

• Large-artery atherosclerotic subtype (TOAST classification) confirmed within 72 hours after stroke onset.

• NIHSS score 4-20 before treatment.

• Pre-stroke modified Rankin Scale (mRS) score ≤1.

• LDL-C ≥1.8 mmol/L before enrollment.

• Able to use evolocumab and statin medications in accordance with the physician's instructions and the prescribing information.

• No prior use of a PCSK9 inhibitor before enrollment.

• Written informed consent provided by the participant or legally authorized representative.

Locations
Other Locations
China
Harbin, Heilongjiang, China, 150001
RECRUITING
Heilongjiang
Contact Information
Primary
Zhongling Zhang
zhang777hyd@163.com
+8613503615988
Backup
Shanshan Yang
yangshanshan81@163.com
+8613845104003
Time Frame
Start Date: 2025-12-03
Estimated Completion Date: 2027-12-01
Participants
Target number of participants: 1000
Treatments
Exposed
Drug: Evolocumab injection. 140 mg subcutaneously every 2 weeks or 420 mg monthly for 90 days.~Other treatment: Daily statin therapy according to routine clinical practice
Non-exposed
Drug: Statin. Daily statin therapy for 90 days according to routine clinical practice.
Related Therapeutic Areas
Sponsors
Leads: First Affiliated Hospital of Harbin Medical University

This content was sourced from clinicaltrials.gov