Early Administration of PCSK9 Inhibitors After Thrombectomy for Atherosclerotic Acute Ischemic Stroke: A Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Incidence of symptomatic intracranial hemorrhage (sICH) within 90 days, defined according to the Heidelberg Bleeding Classification criteria.
研究概览
简要总结
This study (EPOCH-TECT) was a single-center, randomized, open-label, blinded, endpoint-assessing controlled trial conducted at the Affiliated Hospital of Xuzhou Medical University. It aimed to investigate the efficacy and safety of administering the PCSK9 inhibitor evolocumab early (within 6 hours) after successful thrombectomy in patients with atherosclerotic large vessel occlusive stroke. The study planned to enroll 60 patients, who were randomly assigned 1:1 to either the "thrombectomy + evolocumab" group or the "thrombectomy alone" group. The primary endpoint was the incidence of early neurological deterioration within 7 days post-procedure (NIHSS score increase ≥2 points from post-operative best or death from any cause); secondary endpoints included 24-hour recanalization failure rate, 90-day functional recovery (mRS score 0-2), changes in serum biomarkers, and safety indicators such as symptomatic intracranial hemorrhage. This study aimed to provide prospective evidence for early intensive lipid-lowering and neuroprotective strategies after thrombectomy.
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
- Single (Outcomes Assessor)
盲法说明
Only the outcomes assessor is masked to treatment allocation. Participants, care providers, and investigators are not masked (open-label).
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-85 years old, gender not limited, gender ratio not limited.
- •The clinical diagnosis was acute ischemic stroke with occlusion of the anterior circulation large vessels. CTA/DSA confirmed that the responsible vessel for this stroke occlusion was located in the intracranial segment of the internal carotid artery and the M1 segment of the middle cerebral artery.
- •The time from onset to puncture is within 24 hours, and the patient receives mechanical thrombectomy (MT) (including direct thrombectomy and intravenous thrombolysis bridging thrombectomy), with postoperative vascular recanalization reaching mTICI grade 2b or
- •The surgical indications and time window follow the current guidelines and imaging criteria of key randomized controlled trials (RCTs). The definitions are as follows: Early window (0-6 h): Meeting the usual EVT indications (anterior circulation LVO, baseline NIHSS ≥ 6, ASPECTS ≥ 6, or center-defined criteria), the interventional team decides to perform MT; Late window (6-24 h): Meeting one of the imaging selection criteria of DAWN or DEFUSE-3 (based on CTP-RAPID or MRI-DWI/perfusion):
- •·DAWN (6-24 h) (any one): Age ≥ 80 years: NIHSS ≥ 10 and core infarct volume < 21 mL; Age < 80 years: NIHSS ≥ 10 and core < 31 mL; Age < 80 years: NIHSS ≥ 20 and core 31-51 mL.
- •DEFUSE-3 (6-16 h) (all conditions must be met): Core <70 mL, mismatch ratio (penumbra/core) ≥1.8, mismatch volume ≥15 mL, and Tmax >6 s volume >15 mL.
- •The etiological classification is intracranial arteriosclerosis-LAA (ICAD-LAA). The definition is as follows: imaging evidence supports the presence of atherosclerotic stenosis/plaque in the responsible vessel (such as severe stenosis/occlusion of the proximal internal carotid artery or middle cerebral artery) and the patient has corresponding underlying atherosclerosis (such as other intracranial/extracranial artery stenosis, hypertension, diabetes, etc.).
- •Baseline National Institutes of Health Stroke Scale (NIHSS) score ≥ 6 points.
- •Before the onset of the disease, the patient had good daily living abilities and an mRS score ≤ 2 (no severe disability).
- •Able to complete the injection of research drugs as required.
- •The patient or his or her legal representative shall sign a written informed consent form, understand the research content and agree to cooperate with the follow-up.
排除标准
- •Non-atherosclerotic lesions (such as arterial dissection, Moyamoya disease, vasculitis, embolism of unknown origin, etc.).
- •Patients who present with significant intracranial hemorrhage or excessively large cerebral infarction volume upon admission, making them unsuitable for continued participation in the study.
- •The cause of stroke is cardioembolism (such as a history of heart disease such as atrial fibrillation or valvular heart disease).
- •Individuals with a clear history of allergy to evolocumab or its excipients.
- •Patients with severe liver and kidney dysfunction: baseline alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 3 times the upper limit of normal, or significantly reduced creatinine clearance (eGFR < 30 mL/min/1.73m²).
- •Patients with active severe infection, immune system disease or other serious comorbidities that may significantly affect prognosis (such as active tumors, terminal diseases, etc.).
- •Patients who have been treated with PCSK9 inhibitors within the past 4 weeks (to avoid affecting the study due to changes in tolerance or mechanism of action).
- •Pregnant or lactating women.
- •Expected survival <90 days or accompanied by other serious diseases.
- •Currently participating in other interventional clinical studies.
研究组 & 干预措施
intervention group
Intervention Group: Thrombectomy alone + evolocumab
Thrombectomy alone: Mechanical thrombectomy performed according to guidelines (may include necessary angioplasty/stent implantation).
Evolocumab: 420 mg subcutaneously injected within 6 hours after recanalization (140 mg x 3 injections, pre-filled 3 mL total), at the location of the abdomen, lateral thigh, or lateral upper arm.
Both groups received standardized drug therapy: antithrombotic/lipid-regulating/blood pressure/blood glucose/fluid management and rehabilitation: in accordance with the latest clinical guidelines.
干预措施: Evolocumab(420 mg injections) (Drug)
control group
Control group: simple thrombectomy
Both groups received standardized drug therapy: antithrombotic/lipid-regulating/blood pressure/blood glucose/fluid management and rehabilitation: in accordance with the latest clinical guidelines.
结局指标
主要结局
Incidence of symptomatic intracranial hemorrhage (sICH) within 90 days, defined according to the Heidelberg Bleeding Classification criteria.
时间窗: Within 90 days post-thrombectomy
Incidence of symptomatic intracranial hemorrhage (sICH) within 90 days, defined according to the Heidelberg Bleeding Classification criteria.
Early deterioration of neurological function (END)
时间窗: Within 7 days post-thrombectomy
The incidence of early neurological deterioration (END) within 7 days, defined as an increase of ≥2 points in NIHSS score compared to the best post-procedure level or death from any cause.
次要结局
未报告次要终点