Intravenous Thrombolysis Registry for Chinese Ischemic Stroke Within 4.5 h Onset
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 4,000
- 试验地点
- 1
- 主要终点
- Excellent outcome at 3 months
研究概览
简要总结
Stroke is one of the leading causes of death and disability in China. Intravenous thrombolysis with recombinant tissue plasminogen activator (rtPA) improves the outcome for ischemic stroke patients who can be treated within 4.5 hours of symptom onset. In China, in addition to rt-PA, intravenous urokinase within 6 h has also been recommended by the 2010 Chinese Guidelines for the Diagnosis and Treatment of Patients with Acute Ischemic Stroke, and supported by evidence from two intravenous urokinase thrombolysis trials. Urokinase is used more frequently than rt-PA, mainly because it is cheaper. To describe Chinese experience with thrombolytic therapy for Ischemic Stroke within 4.5h onset, we designed a multicenter, prospective, registry study. The aim of INtravenous Thrombolysis REgistry for Chinese Ischemic Stroke within 4.5 h onset（INTRECIS）was to assess the safety and efficacy of intravenous rtPA, urokinase as thrombolytic therapy within the first 4.5 h of onset of acute ischaemic stroke.
详细描述
INTRECIS is a prospective multicenter registry using data from 60 centres in the North China. Consecutive patients with acute ischemic stroke who are treated with intravenous rtPA, urokinase within 4.5 hours of symptom onset in 60 centres of the North China will be eligible for this registry. Patient involvement in the registry shall not influence any treatment decision. Patients will undergo a complete diagnostic work up including a clinical neurological examination using the National Institutes of Health Stroke Scale (NIHSS) score, laboratory examination, brain and neurovascular imaging, echocardiography, 24-hours ECG. Clinical outcome will be evaluated on day 1 and day 14 using the National Institute of Health Stroke Scale (NIHSS) score, evaluated at 3 months using modified Rankin Scale score (mRS) and assessing adverse events. The proportion of patients with excellent outcome (mRS 0 to 1) at 3 months after treatment will serve as the primary outcome. Secondary outcome measures will include independent functional outcome (mRS 0 to 2), changes in NIHSS at 1 and 14 day compared with baseline, symptomatic intracerebral haemorrhage, recurrent stroke and all-cause mortality.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •ischemic stroke diagnosed by CT or MRI
- •first stroke onset or past stroke without obvious neurological deficit (mRS≤1)
- •Time from onset to treatment: ≤ 4.5 hours
- •Treatment with intravenous rtPA or urokinase
- •Signed informed consent by patient self or legally authorized representatives
排除标准
- •History of subarachnoid hemorrhage, intracranial hemorrhage and hemorrhagic cerebral infarction
- •Obvious head injuries or strokes within 3 months
- •Intracranial tumor, arteriovenous malformation or aneurysm
- •Intracranial or spinal cord surgery within 3 months
- •Gastrointestinal or urinary tract hemorrhage within the previous 21 days
- •Blood glucose < 50 mg/dl (2.7mmol/L)
- •Heparin therapy or oral anticoagulation therapy within 48 hours
- •Oral warfarin is being taken and INR>1.6
- •Severe systemic disease which is expected to survive less than 3 months
- •Major surgery within 1 month
- •Uncontrolled hypertension (>180/100 mmHg)
- •Platelet count < 10×109／L
- •Patients who have been involved in other clinical trials within 3 months
研究组 & 干预措施
rtPA
Intravenous rt-PA thrombolysis shall be administered within 4.5 h after symptom onset, at a dose of 0.9 mg/kg body weight (maximum, 90 mg), with 10% of the dose given as a bolus over 1 min and the remaining 90% infused over 60 min.
干预措施: rtPA (Drug)
urokinase
1,000,000-1,500,000 units of urokinase intravenous infused over 30 minutes within 4.5 h of stroke onset .
干预措施: urokinase (Drug)
结局指标
主要结局
Excellent outcome at 3 months
时间窗: 90 days
The proportion of patients with excellent outcome (modified Rankin Score 0 to 1) at 3 months after stroke onset
次要结局
- Functional independence at 3 months after stroke onset(90 days)
- Symptomatic intracerebral haemorrhage(22-36 hours)
- Recurrent stroke(90 days)
- All-cause mortality(1 day, 14 days, 90 days)
- changes in NIHSS score(1 day, 14 days)
研究者
Hui-Sheng Chen
Director of neurology department
General Hospital of Shenyang Military Region