A Prospective, Multicentre, Randomized Controlled Trial of Edaravone Dexborneol in Acute Ischemic Stroke With Active Malignancy
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 144
- 试验地点
- 1
- 主要终点
- Change in NIHSS score from baseline to Day 30 post-treatment.
研究概览
简要总结
This multicenter randomized controlled trial aims to evaluate the efficacy and safety of edaravone dexborneol injection in patients with acute ischemic stroke (AIS) complicated by active malignancies. The study will primarily investigate whether this combined antioxidant and anti-inflammatory treatment can improve neurological functional recovery and assess its safety profile in this high-risk population. Investigators will compare outcomes between the edaravone dexborneol treatment group and a control group receiving standard therapy to determine if the intervention provides superior neuroprotective effects. Participants will receive the assigned treatment regimen, undergo serial neurological assessments and imaging studies to monitor stroke progression and recovery, and be closely followed for safety evaluations. The findings may offer evidence-based therapeutic options for managing this challenging clinical scenario where current treatment alternatives are limited.
详细描述
Patients with acute ischemic stroke (AIS) who also have active malignancies face a more complex clinical scenario, with limited treatment options and generally poor prognoses. The coexistence of these two conditions can interact through inflammatory and oxidative stress pathways, forming a vicious cycle that exacerbates the patient's condition. Edaravone dexborneol injection exhibits significant antioxidant and anti-inflammatory effects, effectively scavenging free radicals in the body, thereby potentially improving the outcomes of AIS patients. Preliminary retrospective study demonstrated that edaravone dexborneol injection can promote neurological recovery in AIS patients with active malignancies and shows a favorable safety profile. Therefore, this study aims to conduct a multicenter randomized controlled trial to evaluate the efficacy and safety of edaravone dexborneol injection in treating AIS patients with active malignancies, with the goal of providing evidence-based medical support and more effective therapeutic strategies for this specific patient population.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 80 years (inclusive);
- •Diagnosis of acute ischemic stroke (AIS) according to the 2023 Chinese Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke;
- •Time from symptom onset to enrollment ≤48 hours;
- •Presence of focal neurological deficits with a baseline NIHSS score of 4-24, and a combined score of ≥2 points on NIHSS Item 5 (upper limb motor) and Item 6 (lower limb motor);
- •Confirmed active malignancy before stroke onset or during hospitalization, defined as: Cancer diagnosed within 12 months prior to stroke, Presence of metastatic disease, Received cancer-directed therapy within the past 30 days, or Patients who declined cancer treatment (still considered active malignancy);
- •Signed informed consent obtained from the patient or legally authorized representative.
排除标准
- •Intracranial hemorrhagic diseases detected on head CT: hemorrhagic stroke, epidural hematoma, intracranial hematoma, intraventricular hemorrhage, subarachnoid hemorrhage, etc;
- •Pre-stroke modified Rankin Scale (mRS) score >1;
- •Transient ischemic attack (TIA) as the current event;
- •Non-invasive skin cancers (e.g., basal cell carcinoma), primary central nervous system tumors, or hematologic malignancies;
- •Use of neuroprotective agents, including but not limited to: marketed edaravone, nimodipine, gangliosides, citicoline, piracetam, butylphthalide, human urinary kallidinogenase, or certain Chinese herbal medicines (see Concomitant Medications for details);
- •Patients with severe psychiatric disorders or dementia;
- •Hepatic or renal dysfunction: ALT or AST >3× upper limit of normal (ULN); Known liver diseases (e.g., acute/chronic active hepatitis, cirrhosis); Known kidney disease, renal insufficiency, serum creatinine >1.5×ULN, or creatinine clearance <50 mL/min;
- •Severe systemic diseases with an expected survival <90 days;
- •Pre-stroke Eastern Cooperative Oncology Group (ECOG) performance status ≥3;
- •Hypersensitivity to edaravone, (+)-borneol, or any excipients;
- •Pregnancy, lactation, or planned pregnancy;
- •Participation in another clinical trial within 30 days prior to randomization or current enrollment in other interventional studies;
- •Any other condition deemed inappropriate for participation by the investigator.
研究组 & 干预措施
Intervention group
Subjects randomized to the trial group will receive edaravone dexborneol injection at a dose of 37.5 mg (consisting of 30 mg edaravone and 7.5 mg dexborneol) administered twice daily with a fixed 12-hour interval between doses. The study drug will be diluted in 100 mL of normal saline and delivered via intravenous infusion over 30 minutes. This treatment regimen will be maintained for a duration of 10 to 14 days, in addition to standard stroke care. Strict adherence to the dosing schedule and infusion protocol will be ensured to maintain treatment consistency across study sites.
干预措施: edaravone dexborneol injection (Drug)
Intervention group
Subjects randomized to the trial group will receive edaravone dexborneol injection at a dose of 37.5 mg (consisting of 30 mg edaravone and 7.5 mg dexborneol) administered twice daily with a fixed 12-hour interval between doses. The study drug will be diluted in 100 mL of normal saline and delivered via intravenous infusion over 30 minutes. This treatment regimen will be maintained for a duration of 10 to 14 days, in addition to standard stroke care. Strict adherence to the dosing schedule and infusion protocol will be ensured to maintain treatment consistency across study sites.
干预措施: Standard therapeutic protocol (Drug)
Control group
Subjects randomized to the control group will receive conventional standard therapy for acute ischemic stroke without the addition of edaravone dexborneol. The standard treatment regimen, which may include antiplatelet therapy, anticoagulation (if indicated), blood pressure management, and other evidence-based interventions, will be administered continuously for 10 to 14 days according to current clinical guidelines. All patients in this group will receive the same intensity of monitoring and follow-up as the experimental group to ensure comparable assessment of outcomes.
干预措施: Standard therapeutic protocol (Drug)
结局指标
主要结局
Change in NIHSS score from baseline to Day 30 post-treatment.
时间窗: From enrollment to the end of treatment at Day 30
次要结局
- mRS score(From enrollment to the end of treatment at Day 30 and Day 90)
- Proportion of patients with mRS score ≤2(From enrollment to the end of treatment at Day 30 and Day 90)
- Change in NIHSS score(From enrollment to the end of treatment at Day 14 and Day 90)
- Incidence of symptomatic intracranial hemorrhage transformation(From enrollment to the end of treatment at 36-48 hours and 7 days)
- Proportion of patients with Barthel Index (BI) score ≥95(From enrollment to the end of treatment at Day 14, Day 30, and Day 90)
- All-cause mortality rate(From enrollment to the end of treatment at Day 30 and Day 90)
- Changes in serum inflammatory markers and coagulation parameters(From enrollment to the end of treatment at Day 14 and Day 30)
- Overall incidence of adverse events (AEs)(From enrollment to the end of treatment at 90 days)
- Incidence of treatment-emergent adverse events (TEAEs)(From enrollment to the end of treatment at 90 days)
- Occurrence of significant adverse events(From enrollment to the end of treatment at 90 days)
- Incidence of serious adverse events (SAEs)(From enrollment to the end of treatment at 90 days)
- Abnormalities in clinical laboratory tests(From enrollment to the end of treatment at 90 days)