Status:
NOT_YET_RECRUITING
PCSK9 Inhibitors in Acute Ischemic Stroke Patients Undergoing Endovascular Therapy
Lead Sponsor:
Nanfang Hospital, Southern Medical University
Conditions:
Acute Ischemic Stroke
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
This is a prospective, multicenter, randomized controlled clinical study to evaluate the efficacy of PCSK9 inhibitor in addition to standard therapy in patients with acute ischemic stroke undergoing e...
Eligibility Criteria
Inclusion
- Age ≥ 18 years.
- Meets the diagnostic criteria for acute ischemic stroke according to the Chinese Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke 2023.
- Severe stenosis or occlusion of large anterior circulation vessels confirmed by DSA, MRA, or CTA.
- Preoperative NIHSS score ≥ 4 and \< 25.
- Meets the indications for endovascular therapy per the Chinese Guidelines for Endovascular Therapy of Acute Ischemic Stroke 2023, and successful reperfusion of the target vessel (mTICI ≥ 2b) achieved via emergency endovascular intervention.
- LDL-C \> 1.8 mmol/L or non-HDL cholesterol \> 2.6 mmol/L.
- Signed informed consent provided by the patient or their legally authorized representative.
Exclusion
- Confirmed non-atherosclerotic causes of vascular stenosis/occlusion (e.g., cardioembolism, vasculitis, vascular malformation, moyamoya disease, iatrogenic causes).
- History of intracranial hemorrhage or systemic bleeding within the past 3 months.
- Presence of hemorrhagic transformation (PH1/PH2) immediately after the procedure.
- Severe hepatic impairment: ALT \> 3 times the upper limit of normal, INR \> 1.2, hepatic encephalopathy, or history of drug-induced liver injury.
- Use of PCSK9 inhibitors within 6 months prior to enrollment.
- Pre-stroke mRS ≥ 2.
- Terminal illness (e.g., malignancy, end-stage renal disease) with an expected survival of \< 3 months.
- Pregnancy or lactation.
- Other neurological diseases that may interfere with neurological function assessment during follow-up.
- Allergy or intolerance to PCSK9 inhibitors or statins.
- Participation in another interventional clinical trial.
Key Trial Info
Start Date :
September 15 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 15 2027
Estimated Enrollment :
478 Patients enrolled
Trial Details
Trial ID
NCT07174375
Start Date
September 15 2025
End Date
December 15 2027
Last Update
September 15 2025
Active Locations (12)
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1
Fujian Medical University Union Hospital
Fuzhou, Fujian, China
2
Dongguan Donghua Hospital
Dongguan, Guangdong, China
3
Dongguan People's Hospital
Dongguan, Guangdong, China
4
Huadu District People's Hospital of Guangzhou
Guangzhou, Guangdong, China