IRCT20210530051440N1招募中3 期
The Study of the Efficacy of Edaravone in Combination with Thrombolysis in Acute Ischemic Stroke Patients: A randomized controlled clinical trial
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 244
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 75 years（—）
- 性别
- All
入选标准
- •Diagnosis AIS as acute onset of neurological symptoms, confirming by neuroimaging examination of the head – computed tomography (CT) or magnetic resonance imaging (MRI)
- •Patients included receiving r-TPA
- •Age 18-75 years
- •NIHSS between 4 and 24with a total score of upper and lower limbs = 2 on motor deficits
- •Patients receiving Edaravone within 1 to 24 hour of admission
排除标准
- •Cranial CT scan finds intracranial bleeding disorders
- •Arterial dissection,
- •Despite initial controlling of blood pressure (BP); systolic BP still greater than or equal to 220 mmHg, or diastolic BP greater than or equal to 120 mmHg
- •Iatrogenic stroke
- •Patients with severe mental disorders and dementia
- •Significant lung disease (FEV1 =1.5 L, pO2 =70 on room air, pCO2 =45)
- •Psychiatric illness requiring medication
- •Prior consumption of therapeutic neuroprotective agents, including commercially available Edaravone, Nimodipine, Ganglioside, Citicoline or Piracetam
- •Patients with malignant tumors or receiving concurrent antitumor treatment
- •Patients with severe systemic disease or life expectancy less than 90 days
- •Pregnant or lactating women
- •History of hypersensitivity to Edaravone or any of the inactive ingredients, including sulfite hypersensitivity
- •MRS = 2 prior to stroke
- •NIHSS = 25 or = 3 in admission
- •Severe disturbance of consciousness: NIHSS category 1a for consciousness = 2
- •History of AIS within 3 months
- •Severe heart disease (Ejection Fraction less than 30%)
- •Baseline Creatinine clearance less than 30 ml/min, creatinine 150 mol/L or previously known severe renal diseases
- •ALT or AST is greater than 2.0×ULN or previously known liver diseases, such as acute hepatitis, chronic active hepatitis or liver cirrhosis
- •Infections requiring antibiotic administration
- •Manifesting considerable improvement in neurologic signs and symptoms indicating transient ischemic attack
研究者
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