NCT01104467已完成2 期
Randomised, Double-blind, Placebo-controlled, Dose-escalation Study of Desmoteplase in Japanese Patients With Acute Ischemic Stroke
Lundbeck Japan K. K.19 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2010年8月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 19
- 主要终点
- To evaluate the safety and tolerability of desmoteplase doses of 70 µg/kg and 90 µg/kg in Japanese patients with acute ischemic stroke as measured by the presence of symptomatic intracranial haemorrhage (sICH) within 72 hours after IMP
研究概览
简要总结
The purpose of the study is to evaluate whether desmoteplase is safe and tolerated when given to Japanese patients with acute ischemic stroke
详细描述
The study is a safety and tolerability study of desmoteplase in Japanese patients with acute ischemic stroke. The study will test two doses
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of acute ischemic stroke
- •Provided Informed Consent
- •Male or female
- •Aged between 20 and 85 years inclusive
- •Treatment within 3-9 hr after onset of stroke symptoms.
- •NIHSS score of 4-24 inclusive with clinical signs of hemispheric infarction
- •Must receive IMP within 60 minutes after brain imaging
- •Cerebral artery occlusion or high-grade stenosis in MCA
排除标准
- •Pre-stroke mRS score of >1
- •Previously exposed to desmoteplase
- •Scores >2 on NIHSS question 1a indicating coma
- •History or clinical presentation of ICH, subarachnoid haemorrhage (SAH), arterio-venous malformation (AVM), moyamoya disease, cerebral neoplasm or aneurysm
- •Current use of oral anticoagulants and a prolonged prothrombin time (INR >1.6)
- •Treated with heparin in the previous 48 hours and has a prolonged partial thromboplastin time
- •Baseline platelet count <100,000/mm3
- •Baseline haematocrit of <0.25
- •Baseline blood glucose <50 mg/dl or >200 mg/dl
- •Uncontrolled hypertension defined by a blood pressure, systolic >185 mmHg or diastolic >110 mmHg on at least 2 separate occasions at least 10 minutes apart
- •Patient has hereditary or acquired hemorrhagic diathesis
- •Gastrointestinal or urinary bleeding within the past 21 days
- •Arterial puncture in a non-compressible site within the previous 7 days
- •Another stroke or a serious head injury in the past 6 weeks
- •Major surgery or serious injury, including other sites than the head, within the preceding 14 days
- •Seizure at the onset of stroke
- •Acute myocardial infarction (AMI) within the previous 3 weeks
- •Thrombolytic within the previous 72 hr
- •Other inclusion and exclusion criteria may apply.
研究组 & 干预措施
Desmoteplase 70 µg/kg
Experimental
干预措施: Desmoteplase (Drug)
Desmoteplase 90 µg/kg
Experimental
干预措施: Desmoteplase (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Other)
结局指标
主要结局
To evaluate the safety and tolerability of desmoteplase doses of 70 µg/kg and 90 µg/kg in Japanese patients with acute ischemic stroke as measured by the presence of symptomatic intracranial haemorrhage (sICH) within 72 hours after IMP
时间窗: 90 days
次要结局
- To evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) of desmoteplase(0.5 - 9 hr)
- To evaluate recanalisation at 18±6 hr after administration of IMP(18±6 hr after administration of IMP)
- To explore the predictive value of different volumes of absolute mismatch for the clinical response and other objectives(Day 90)
- To evaluate the clinical improvement at Day 90 after administration of Investigational Medicinal Product (IMP) as measured by modified Rankin Scale (mRS)(90 days)
- To evaluate change in infarct size at 18±6 hr relative to pre-treatment infarct size(18±6 hr after administration)
- To evaluate the clinical improvement at Day 7 and 30 after administration of IMP as measured by modified Rankin Scale (mRS)(Day 7 and Day 30)
- To evaluate the immunogenicity of desmoteplase(Day 7, Day 30, Day 90)
研究者
研究点 (19)
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