A Randomised, Double-blind, Parallel-group Placebo-controlled Phase III Study to Evaluate the Efficacy and Safety of Desmoteplase in Subjects With Acute Ischemic Stroke
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 492
- 试验地点
- 102
- 主要终点
- Modified Rankin Scale Score
研究概览
简要总结
The purpose of the study is to determine whether desmoteplase is effective and safe in the treatment of patients with acute ischaemic stroke when given within 3-9 hours from onset of stroke symptoms.
详细描述
Acute stroke is a major cause of mortality and long-term disability in the developed world. The only currently approved thrombolytic intervention for acute ischemic stroke, which constitutes the majority of strokes, is alteplase (recombinant tissue plasminogen activator; rtPA). The use of alteplase is limited as it is approved for use within 3 hours after symptom onset and by the risk of inducing intracerebral haemorrhage; consequently fewer than 3% of acute stroke subjects are treated. The thrombolytic agent desmoteplase (recombinant Desmodus Salivary Plasminogen Activator alpha-1; rDSPAalpha-1) produced by recombinant biotechnology has its naturally occurring counterpart in the saliva of the vampire bat Desmodus rotundus. Compared to alteplase, desmoteplase has a more favourable profile in terms of high fibrin specificity and non neurotoxicity.
The study aims to confirm efficacy and safety of desmoteplase for thrombolytic therapy of patients with acute ischaemic stroke in the extended time window of 3-9 hours after onset of stroke symptoms.
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, Investigator)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of acute ischemic stroke
- •Informed consent
- •Age between 18 and 85 years
- •Treatment can be initiated within 3-9 hours after the onset of stroke symptoms
- •NIHSS Score of 4-24
- •Vessel occlusion or high-grade stenosis on MRI or CTA in proximal cerebral arteries
排除标准
- •Pre-stroke mRS >1
- •Previous exposure to desmoteplase
- •Extensive early infarction on MRI or CT in any affected area
- •Imaging evidence of ICH or SAH; AV malformation; cerebral aneurysm; or cerebral neoplasm
- •Internal carotid artery occlusion on the side of the stroke lesion
- •Treatment with heparin in the past 48 hours and a prolonged partial thromboplastin time
- •Treatment with oral anticoagulants and a prolonged prothrombin time
- •Treatment with glycoprotein IIb - IIIa inhibitors within the past 72 hours. Use of single agent oral platelet inhibitors is permitted
- •Treatment with a thrombolytic agent within the past 72 hours
研究组 & 干预措施
Desmoteplase
干预措施: Desmoteplase (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Modified Rankin Scale Score
时间窗: 90 days
次要结局
- National Institutes of Health Stroke Scale (NIHSS) Score(90 days)