Evaluation Study of Early Administration of Evolocumab After Thrombolysis in Patients With Atherosclerotic Acute Ischemic Stroke

NCT07301372 | Recruiting Phase 4 DMC

• 1 other identifier: XYFY2025-KL477-02
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a Phase IIa clinical trial initiated by the researchers, which is prospective, single-center, randomized, open-label, with blinded endpoint evaluation (PROBE design). Patients were screened through the emergency stroke green channel and included if they had an onset within 9 hours, met the criteria for large artery atherosclerosis (LAA) after multimodal imaging screening, received intravenous thrombolysis, and signed informed consent to participate. The study used block randomization (block size of 4), stratified by baseline National Institutes of Health Stroke Scale (NIHSS) score (5-10 vs \>10-20) and onset-to-thrombolysis time (\<4.5 hours vs 4.5-9 hours). Intervention group: received subcutaneous injections of Ilyumumab 420 mg (three syringes) within 24 hours after thrombolysis plus standard drug therapy (including statins). Control group: received conventional statin therapy (atorvastatin 20 mg/day) after thrombolysis. All patients received standardized stroke treatment (initiating antiplatelet therapy 24 hours after thrombolysis) and standardized management of blood pressure and blood glucose. NIHSS scores were assessed every 12 hours within 72 hours post-thrombolysis, and then daily thereafter, to evaluate the effectiveness of combined therapy in reducing early neurological deterioration (END). Blinding: The study is open-label. An independent Clinical Endpoint Committee (CEC) was established, and all clinical endpoint events (END assessment, 90-day mRS scores) were evaluated in a blinded manner by experts who were completely unaware of group assignments.

Conditions

Acute Stroke

Keywords

PCSK9 inhibitor; Inflammatory factor; Biomarkers of brain injury; Atorvastatin; Early neurological deterioration

Outcome Measures

Primary Outcomes (1)

• Early deterioration of neurological function (END)

  Defined as an increase of ≥2 points in NIHSS score or death within 1-7 days after thrombolysis. NIHSS scores should be assessed daily.The NIHSS (National Institutes of Health Stroke Scale) has a total score of 0 to 42. The higher the total score, the more severe the neurological deficit caused by stroke.

  within 1-7 days after thrombolysis.

Secondary Outcomes (6)

• Therapeutic efficacy

  Within 90 days after thrombolysis

• Mechanism exploration

  from baseline to 36 hours and 72 hours after thrombolysis.

• Mechanism Exploration

  from baseline to 36 hours and 72 hours after thrombolysis

• Mechanism Exploration

  from baseline to 36 hours and 72 hours after thrombolysis

• Mechanism Exploration

  from baseline to 36 hours and 72 hours after thrombolysis

Study Arms (2)

evolocumab

EXPERIMENTAL

Within 24 hours after thrombolysis, patients received subcutaneous injections of 420 mg evokine and three vials of evokine, along with standard statin therapy (atorvastatin 20 mg/day).

Drug: Ivolumab 420mg (three vials)

Standard of care

NO INTERVENTION

Following thrombolysis, the patient received standard statin therapy (atorvastatin 20 mg/day).

Interventions

Ivolumab 420mg (three vials) DRUG

Administer 420 mg (three vials) of evolocumab subcutaneously within 24 hours after thrombolysis.

evolocumab

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Age 18-85 years. No gender or sex restrictions, and no gender ratio restrictions.
• \. Clinically diagnosed with acute ischemic stroke, with the time from symptom onset to intravenous thrombolysis \<9 hours.
• Within 4.5 hours of symptom onset: This time window is based on the ECASS III criteria (Class IA recommendation) and is currently the standard indication for intravenous thrombolysis in acute ischemic stroke worldwide.
• hours: Referring to the EXTEND study criteria, meeting the following multimodal imaging mismatch ratio: ischemic penumbra volume/ischemic core volume \>1.2, with an absolute mismatch volume \>10 mL and an ischemic core volume \<70 mL.
• \. The stroke meets the TOAST classification for large artery atherosclerosis (LAA), which includes intracranial arteriosclerosis (ICAS) and extracranial arteriosclerosis (ECAS), and meets one of the following three criteria: large artery stenosis ≥50%, infarct lesion \>1.5cm + ipsilateral plaque (no stenosis requirement), or intracranial artery stenosis ≥30% with plaque ulceration.
• \. The patient or their legal representative has signed an informed consent form.

You may not qualify if:

• \. CT scan showing signs of intracranial hemorrhage, symptomatic intracranial hemorrhage, or subarachnoid hemorrhage, even if the CT scan results are normal.
• \. Patients who must or wish to continue using restrictive medications or any medications that may interfere with the safe conduct of the trial.
• \. Acute bleeding tendency, including but not limited to:
• A known family history of bleeding disorders and a history of a serious bleeding disorder currently present or within the past 6 months.
• Receiving heparin treatment within the past 48 hours, with an activated partial thromboplastin time (aPTT) exceeding the upper limit of the normal range for laboratory testing.
• Currently taking an oral vitamin K anticoagulant (e.g., warfarin) with a prolonged prothrombin time (INR \> 1.7 or PT \> 15 seconds); or currently taking a novel oral anticoagulant (e.g., dabigatran etexilate, rivaroxaban, or apixaban) with an activated partial thromboplastin time (aPTT) and/or prothrombin time (PT) exceeding the upper limit of the local laboratory reference range.
• Platelet count below 100,000/mm³ at screening.
• History of central nervous system injury (e.g., tumor, aneurysm, intracranial or spinal surgery).
• Experiencing traumatic external cardiac compression, obstetric delivery, or non-compressive vascular puncture (e.g., subclavian or jugular vein puncture) within the past 10 days.
• Known history of suspected intracranial hemorrhage or suspected aneurysm/subarachnoid hemorrhage.
• Tumors with increased bleeding risk.
• History of ulcerative gastrointestinal disease, esophageal varices, aneurysm, or arteriovenous malformation within the past 3 months.
• Associated with bleeding risk. 4. Any known disease significantly associated with this condition.
• \. Previous mRS score ≥2, with comorbid dementia or other neurodegenerative diseases.
• \. Clinically confirmed non-atherosclerotic intracranial arterial stenosis, such as aortic dissection, vasculitis, moyamoya disease, embolism, immune system disorders, etc.

Sponsors & Collaborators

• The Affiliated Hospital of Xuzhou Medical University: lead

Study Sites (1)

Department of Neurology

Xuzhou, Jiangsu, China

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

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

Study Officials

• Ren Guo Chen

  the Ethics Committee of the Affiliated Hospital of Xuzhou Medical University

  STUDY DIRECTOR

Central Study Contacts

Yu Feng

CONTACT

+8615252148124; xyfysjnkfy@126.com

Shi Qin Ju

CONTACT

+8618335632780; jsq740419@126.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2025
• First Posted: December 24, 2025
• Study Start: October 30, 2025
• Primary Completion (Estimated): August 30, 2026
• Study Completion (Estimated): August 30, 2026
• Last Updated: December 24, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)