A Prospective, Randomized, Double-blind, Placebo-controlled, Single Bolus, Multinational, Multi-center, Parallel Group, Dose-ranging Study of Desmoteplase (INN) in the Indication of Acute Stroke
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 193
- 试验地点
- 44
- 主要终点
- National Institutes of Health Stroke Scale (NIHSS)
研究概览
简要总结
The purpose of this study is to evaluate desmoteplase (which is a manufactured protein derived from the saliva of the vampire bat) in dissolving clots that are blocking the flow of blood through one (or more) of the blood vessels supplying the brain, thereby reopening the blocked blood vessel and allowing blood to flow again in individuals suffering from ischemic stroke.
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
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Eligible for study treatment within 3-9 hours after onset of stroke symptoms.
- •Score of 4-24 on the NIHSS with clinical signs of hemispheric infarction (i.e. hemiparesis) suggestive of ischemic stroke.
- •Inclusion Criteria from diagnostic imaging screening:
- •Distinct penumbra (at least 20%), measured by MRI (PWI/DWI) or perfusion CT, related to middle cerebral artery (MCA), anterior cerebral artery (ACA), or posterior cerebral artery (PCA) territory in a hemispheric distribution.
排除标准
- •History or clinical presentation of intracranial hemorrhage (ICH), subarachnoid hemorrhage, arteriovenous malformation, aneurysm, or cerebral neoplasm.
- •Rapidly improving neurological symptoms.
- •Pre-stroke MRS score of > 1 (including previous disability).
- •Suspected acute vertebral or basilar artery occlusion.
- •Current use of anticoagulants and a prolonged prothrombin time.
- •Uncontrolled hypertension.
- •Baseline hematocrit of < 0.
- •Baseline platelet count < 100,000/mm3.
研究组 & 干预措施
Desmoteplase, low dose
Desmoteplase 90 mcg/kg, intravenous administration.
干预措施: Desmoteplase (Drug)
Desmoteplase, high dose
Desmoteplase 125 mcg/kg, intravenous administration.
干预措施: Desmoteplase (Drug)
Placebo
Dose-Match Placebo, intravenous administration.
干预措施: Placebo (Drug)
结局指标
主要结局
National Institutes of Health Stroke Scale (NIHSS)
时间窗: Change from Baseline to day 90
Improvement of greater than or equal to 8 points from baseline, or NIHSS score less than or equal to 1. The NIHSS score ranges from 0 (least severe) to 42 (more severe).
Modified Rankin Scale (MRS)
时间窗: Day 90
Improvement on the Modified Rankin Scale, defined as a score of 0-2. The MRS ranges in severity from 0 (no symptoms) to 6 (Dead).
Barthel Index (BI) score of 75-100.
时间窗: Day 90
The Barthel Index (BI) is a scale used to measure performance in basic Activities of Daily Livingranges from 0 (most disablility) to 100 (no disability)
次要结局
- Percentage of patients with BI score of 75-100(Day 90)
- Percentage of patients with MRS score of 0-2(Day 90)
- Percentage of patients with improvement in NIHSS score(From Baseline to Day 90)
- Infarct Volume(Change from baseline to Day 30)