A Randomized, Open-label, Blinded Endpoint Evaluation Study of Early Administration of Evolocumab After Thrombolysis in Patients With Atherosclerotic Acute Ischemic Stroke

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: f
View:

⁃ 1\. Age 18-85 years. No gender or sex restrictions, and no gender ratio restrictions.

⁃ 2\. 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.

• 4.5-9 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.

⁃ 3\. 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.

⁃ 4\. The patient or their legal representative has signed an informed consent form.

Locations
Other Locations
China
Department of Neurology
RECRUITING
Xuzhou
Contact Information
Primary
Yu Feng
xyfysjnkfy@126.com
+8615252148124
Backup
Shi Qin Ju
jsq740419@126.com
+8618335632780
Time Frame
Start Date: 2025-10-30
Estimated Completion Date: 2026-08-30
Participants
Target number of participants: 132
Treatments
Experimental: evolocumab
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).
No_intervention: Standard of care
Following thrombolysis, the patient received standard statin therapy (atorvastatin 20 mg/day).
Related Therapeutic Areas
Sponsors
Leads: The Affiliated Hospital of Xuzhou Medical University

This content was sourced from clinicaltrials.gov