NCT00132509终止2 期
Comparison of the Classical Rt-PA Procedure (0.9mg/kg Over 60 Minutes) With a Longer Procedure With Lower Dose (0.8mg/kg Over 90 Minutes) in Acute Ischemic Stroke
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Modified Rankin score
研究概览
简要总结
Data from the literature have suggested that a longer time of thrombolysis might be more effective in ischemic stroke. We, the investigators at Hospices Civils de Lyon, have designed a randomized protocol to test this hypothesis. Moreover, the therapeutic window is 7 hours.
Rt-PA (alteplase) is injected intravenously in the 2 arms of the study for a duration of 60 minutes in the arm with a "classical dose" and 90 minutes in the arm with a "low dose-longer infusion".
This is a study of the outcome at 90 days.
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 (Participant)
入排标准
- 年龄范围
- 18 Years 至 81 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Symptoms of ischemic stroke
- •Presence of a deficit measurable with National Institutes of Health Stroke Scale (NIHSS)
- •Lack of any hemorrhagic lesion on the computed tomography (CT) scan at entry
- •Time of therapy less than 7 hours after onset of stroke
- •Permanent or aggravating symptoms
- •Ages 18-81
排除标准
- •Lack of cerebral infarction or of cranial trauma within 3 weeks before therapy
- •No surgery within 14 days before therapy
- •History of cerebral bleeding
- •Blood pressure: systolic >185 mmHg and/or diastolic >110 mmHg
- •Minor symptoms or symptoms rapidly improving
- •Gastro-intestinal or urinary hemorrhage within 21 days
- •Arterial puncture within 7 days before therapy
- •Epileptic seizure at the beginning of stroke
- •Patients under oral anticoagulants or having received heparin within 48 hours, and with elevated activated partial thromboplastin time (aPTT)
- •Patients with elevated International Normalized Ratio (INR) or thrombocyte count < 100 x 10^9
- •Blood glucose value < 2.7 mmol/l or > 22.2 mmol/l
- •Cardiac, pulmonary, hepatic or renal failure, not allowing a study over 3 months
- •History of gastric ulcer within 15 days; gestation and menstruation
研究组 & 干预措施
DFIL
Experimental
干预措施: DFIL (Drug)
NINDS
Active Comparator
干预措施: NINDS (Drug)
结局指标
主要结局
Modified Rankin score
时间窗: day 90
次要结局
未报告次要终点
研究者
研究点 (1)
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