NCT03541668已完成3 期
A Phase III Trial to Assess the Efficacy and Safety of Recombinant Human Prourokinase in the Treatment of Acute Acute Ischaemic Stroke in 4.5 Hours After Stroke Onset
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 674
- 试验地点
- 35
- 主要终点
- Functional handicap
研究概览
简要总结
This is a randomized, rt-PA controlled, open-label phase 3 clinical study to evaluate the efficacy and safety of recombinant human urokinase(rhPro-UK) versus rt-PA thrombolysis for patients with acute ischaemic stroke in 4.5 hours after stroke onset.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ischemic stroke with symptoms of neurological deficits.
- •Aged 18 to 80 years（including the critical value）.
- •NIH Stroke Scale（NIHSS）scores of 4 to 25（including the critical value）.
- •Treatment within 4.5 hours after stroke onset.
- •The symptoms of stroke last at least 30 minutes without significant improvement before treatment.
- •CT showed negative or signs of early infarction.
- •Informed Consent Form signed by the patients or family (legal representatives) must be provided.
排除标准
- •Patients with premorbid modified Rankin Scale (mRS) score ≥2
- •CT showed multiple infarctions（low density> 1/3 cerebral hemisphere）.
- •Transient ischemic attack.
- •Epileptic seizure after stroke.
- •Intracranial tumor, arteriovenous malformation and aneurysm.
- •Iatrogenic Stroke.
- •Planned for thrombectomy.
- •Cardioembolism and atrial fibrillation.
- •Myocardial infarction history within 3 months.
- •Severe cerebral trauma or stroke history within 3 months.
- •Patients with systolic blood pressure ≥ 180mmHg or diastolic blood pressure ≥ 100mmHg after anti-hypertension treatment.
- •Intracranial hemorrhage or subarachnoid hemorrhage on baseline.
- •Active visceral hemorrhage.
- •Patients with intracerebral hemorrhage history.
- •Patients with diabetic retinopathy history.
- •Puncture in 1 week which can not be oppressed.
- •Major surgery or severe trauma within 2 weeks.
- •Intracranial surgery, intraspinal surgery or solid organ biopsy within 30 days.
- •Heparin treatment within 48h and increased APTT is above ULN.
- •Using of oral anticoagulant drugs and PT >15s or INR >1.
- •High risk of acute hemorrhage include platelet count<10^9/L.
- •Using of thrombin inhibitors or factor Xa inhibitor with abnormal results of sensitive laboratory examination.
- •Blood glucose < 2.7 mmol/L or > 22.2 mmol/L.
- •Pregnancy, lactating or menstrual women.
- •The investigator believes that the patient is not suitable for the study.
研究组 & 干预措施
Group A
Experimental
Recombinant human urokinase (rhPro-UK)
干预措施: Recombinant human urokinase (Drug)
Group B
Active Comparator
Alteplase(rt-PA)
干预措施: Alteplase (Drug)
结局指标
主要结局
Functional handicap
时间窗: 90days
Proportion of patients achieving a Modified Rankin Scale(mRS,which has a range of 0 to 6, with 0 indicating no symptoms at all and 6 indicating death) of 0 to 1 at 90 days after treatment.
次要结局
- Renal function(7 days)
- Systemic hemorrhage(90days)
- Symptomatic intracerebral hemorrhage(90days)
- Recurrence(7 days)
- Scores of Neurological Improvement(24 hours)
- Proportion of Long-term Improvement(90 days)
- Proportion of Neurological Improvement(90 days)
- Long-term Change from Baseline(90 days)
- Death(7 days and 90 days)
- Liver function(7 days)
研究者
研究点 (35)
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