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
Sites (12)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Dongguan People's Hospital Coordinator of this site? Confirm its status | Dongguan | China | Unknown status |
| Dongguan Donghua Hospital Coordinator of this site? Confirm its status | Dongguan | China | Unknown status |
| Fujian Medical University Union Hospital Coordinator of this site? Confirm its status | Fuzhou | China | Unknown status |
| Ganzhou City People's Hospital Coordinator of this site? Confirm its status | Ganzhou | China | Unknown status |
| Huadu District People's Hospital of Guangzhou Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| Nanfang Hospital of Southern Medical University Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| Haikou People's Hospital Coordinator of this site? Confirm its status | Haikou | China | Unknown status |
| Hainan Provincial Hospital of Traditional Chinese Medicine Coordinator of this site? Confirm its status | Haikou | China | Unknown status |
| Hainan Provincial People's Hospital Coordinator of this site? Confirm its status | Haikou | China | Unknown status |
| The Second Affiliated Hospital of Hainan Medical University Coordinator of this site? Confirm its status | Haikou | China | Unknown status |
| Hengzhou City People's Hospital, Guangxi Coordinator of this site? Confirm its status | Hengzhou | China | Unknown status |
| Heyuan People's Hospital Coordinator of this site? Confirm its status | Heyuan | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.