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NCT07174375Not yet recruitingPhase 2/3

PCSK9 Inhibitors in Acute Ischemic Stroke Patients Undergoing Endovascular Therapy

Efficacy and Safety of PCSK9 Inhibitors in Patients With Acute Ischemic Stroke Undergoing Endovascular Therapy: A Prospective, Multicenter, Open-Label, Parallel, Randomized Controlled Clinical Trial

Source: ClinicalTrials.gov · Last updated 15 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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 endovascular therapy.

Status (registry)
Not yet recruiting
Phase (registry)
Phase 2/3
Study type
Interventional
Enrollment
478 (estimated)
First submitted
12 Sept 2025
Start date
15 Sept 2025
Primary completion date
15 Dec 2027
Lead sponsor
Nanfang Hospital, Southern Medical University
Diseases
Stroke
NCT number
NCT07174375

What you commit to

  • Study type: Interventional · Phase 2/3
  • Planned participants: 478
  • From 15 Sept 2025 to the primary completion date, 15 Dec 2027
  • 12 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Use of PCSK9 inhibitors within 6 months prior to enrollment.

Other illness

  • 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.
  • Pre-stroke mRS ≥ 2.
  • Terminal illness (e.g., malignancy, end-stage renal disease) with an expected survival of \< 3 months.
  • Other neurological diseases that may interfere with neurological function assessment during follow-up.
  • Allergy or intolerance to PCSK9 inhibitors or statins.

Lab values

  • Severe hepatic impairment: ALT \> 3 times the upper limit of normal, INR \> 1.2, hepatic encephalopathy, or history of drug-induced liver injury.

Other

  • Presence of hemorrhagic transformation (PH1/PH2) immediately after the procedure.
  • Pregnancy or lactation.
  • Participation in another interventional clinical trial.

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (12)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Dongguan People's Hospital
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DongguanChinaUnknown status
Dongguan Donghua Hospital
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DongguanChinaUnknown status
Fujian Medical University Union Hospital
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FuzhouChinaUnknown status
Ganzhou City People's Hospital
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GanzhouChinaUnknown status
Huadu District People's Hospital of Guangzhou
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GuangzhouChinaUnknown status
Nanfang Hospital of Southern Medical University
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GuangzhouChinaUnknown status
Haikou People's Hospital
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HaikouChinaUnknown status
Hainan Provincial Hospital of Traditional Chinese Medicine
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HaikouChinaUnknown status
Hainan Provincial People's Hospital
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HaikouChinaUnknown status
The Second Affiliated Hospital of Hainan Medical University
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HaikouChinaUnknown status
Hengzhou City People's Hospital, Guangxi
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HengzhouChinaUnknown status
Heyuan People's Hospital
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HeyuanChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.