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Not yet taking people in ChinaPhase 2/3

PCSK9 Inhibitors Tested in Stroke Patients Receiving Endovascular Therapy

Tests a PCSK9 inhibitor added to standard care in adults with acute ischemic stroke.

Plain-language title generated from the registry record
Registry title: PCSK9 Inhibitors in Acute Ischemic Stroke Patients Undergoing Endovascular Therapy

Key facts

Where
Dongguan, Fuzhou, Ganzhou, Guangzhou, Haikou, Hengzhou, and Heyuan, ChinaSee the 12 sites
Phase
Phase 2/3

AI summary: who the study is looking for

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults who had an acute ischemic stroke caused by a blocked large artery. They must have had a clot-removal procedure that reopened the vessel.

Age
18 years or older
Sex
All sexes can join
Disease stage
Acute ischemic stroke with severe narrowing or blockage of a large artery at the front of the brain. NIHSS score of 4 or more and under 25 before the procedure. Blood flow restored by the procedure (mTICI ≥ 2b).
Earlier treatment
Must have had emergency endovascular therapy that reopened the vessel. Cannot have used PCSK9 inhibitors in the 6 months before joining.
Biomarker or test result
LDL-C above 1.8 mmol/L (70 mg/dL) or non-HDL cholesterol above 2.6 mmol/L (101 mg/dL)

Main reasons for not taking part

  • Narrowing or blockage not caused by atherosclerosis (for example heart-related clots or vasculitis)
  • Bleeding in the head or body in the past 3 months, or bleeding right after the procedure
  • Severe liver problems
  • Pre-stroke mRS of 2 or more
  • Pregnancy or breastfeeding

Read by machine on 12 November 2026.

Where in China

  • Dongguan Donghua HospitalDongguan, ChinaContact: Kaibin Huang, Ph.D.No longer taking part
  • Dongguan People's HospitalDongguan, ChinaContact: Kaibin Huang, Ph.D.No longer taking part
  • Fujian Medical University Union HospitalFuzhou, ChinaContact: Kaibin Huang, Ph.D.No longer taking part
  • Ganzhou City People's HospitalGanzhou, ChinaContact: Kaibin Huang, Ph.D.No longer taking part
  • Huadu District People's Hospital of GuangzhouGuangzhou, ChinaContact: Kaibin Huang, Ph.D.No longer taking part
  • Nanfang Hospital of Southern Medical UniversityGuangzhou, ChinaContact: Kaibin Huang, Ph.D.No longer taking part
  • Haikou People's HospitalHaikou, ChinaContact: Kaibin Huang, Ph.D.No longer taking part
  • Hainan Provincial Hospital of Traditional Chinese MedicineHaikou, ChinaContact: Kaibin Huang, Ph.D.No longer taking part
  • Hainan Provincial People's HospitalHaikou, ChinaContact: Kaibin Huang, Ph.D.No longer taking part
  • The Second Affiliated Hospital of Hainan Medical UniversityHaikou, ChinaContact: Pengxiang Li, M.D.No longer taking part
  • Hengzhou City People's Hospital, GuangxiHengzhou, ChinaContact: Youai Chen, M.D.No longer taking part
  • Heyuan People's HospitalHeyuan, ChinaContact: Kaibin Huang, Ph.D.No longer taking part

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

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Trial details

Who runs it
Nanfang Hospital, Southern Medical University
Trial code
NCT07174375
Record updated
15 September 2025
Original description
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.Read full original descriptionShow less

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

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.

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: Use of PCSK9 inhibitors within 6 months prior to enrollment; 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; Severe hepatic impairment: ALT > 3 times the upper limit of normal, INR > 1.2, hepatic encephalopathy, or history of drug-induced liver injury; Presence of hemorrhagic transformation (PH1/PH2) immediately after the procedure; Pregnancy or lactation; Participation in another interventional clinical trial.

ClinicalTrials.gov NCT07174375