NCT07174375尚未招募2 期
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
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 478
- 试验地点
- 12
- 主要终点
- Functional outcome: The proportion of mordified Rankin Scale of 0 to 2 points
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •Severe stenosis or occlusion of large anterior circulation vessels confirmed by DSA, MRA, or CTA.
- •Preoperative NIHSS score ≥ 4 and <
- •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.
排除标准
- •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 ≥
- •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.
研究组 & 干预措施
Standard therapy plus PCSK9 inhibitor
Experimental
Patients in the Standard therapy plus PCSK9 inhibitor group will receive a subcutaneous injection of either Evolocumab (420 mg) or Alirocumab (150 mg) within 48 hours after endovascular therapy, followed by subsequent subcutaneous injections of Evolocumab (420 mg) or Alirocumab (150 mg) every 4 weeks, for a total of 3 administrations.
干预措施: PCSK9 inhibitor (Drug)
结局指标
主要结局
Functional outcome: The proportion of mordified Rankin Scale of 0 to 2 points
时间窗: 90 days after the stroke onset
The proportion of mordified Rankin Scale of 0 to 2 points at 90 days
次要结局
- Proportion of patients with early neurological improvement(7 days post-treatment)
- Incidence of target vessel reocclusion or recurrent infarction(90 days after the stroke onset)
- Reduction amplitude of low-density lipoprotein (LDL-C)(Within 7 days post-treatment)
- Mortality rate(90 days after the stroke onset)
- Incidence of symptomatic hemorrhagic transformation(Within 7 days post-treatment)
- Incidence of acute liver injury(Within 90 days post-treatment)
- Proportion of patients with early neurological deterioration(Within 7 days post-treatment)
- Distribution of modified Rankin Scale (mRS) scores(90 days after the stroke onset)
- Incidence of malignant brain edema(48 to 96 hours after onset)
- Midline shift distance(72 to 96 hours after onset)
- Incidence of adverse events(Within 90 days post-treatment)
研究者
研究点 (12)
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