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
Where in China
- Dongguan Donghua HospitalDongguan, ChinaNo longer taking part
- Dongguan People's HospitalDongguan, ChinaNo longer taking part
- Fujian Medical University Union HospitalFuzhou, ChinaNo longer taking part
- Ganzhou City People's HospitalGanzhou, ChinaNo longer taking part
- Huadu District People's Hospital of GuangzhouGuangzhou, ChinaNo longer taking part
- Nanfang Hospital of Southern Medical UniversityGuangzhou, ChinaNo longer taking part
- Haikou People's HospitalHaikou, ChinaNo longer taking part
- Hainan Provincial Hospital of Traditional Chinese MedicineHaikou, ChinaNo longer taking part
- Hainan Provincial People's HospitalHaikou, ChinaNo longer taking part
- The Second Affiliated Hospital of Hainan Medical UniversityHaikou, ChinaNo longer taking part
- Hengzhou City People's Hospital, GuangxiHengzhou, ChinaNo longer taking part
- Heyuan People's HospitalHeyuan, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
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.