EUCTR2011-005317-37-AT进行中（未招募）1 期
Double blind, placebo controlled, escalating single-dose, pilot study to assess the safety of THR-18 when administered to patients suffering acute ischemic stroke and treated with tPA
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 22
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1) Male or female.
- •2) Diagnosis of acute ischemic stroke onset less than 3 hours prior to the planned start of intravenous tPA (alteplase).
- •3) Have suffered an acute hemispheric ischemic stroke, defined as acute, focal, neurological deficit(s), secondary to a presumed vascular event, which must include at least one of the following:
- •At least one of the following components (as reflected by at least 1 point on any of the corresponding items of the NIHSS: 9, 3 or 11):
- •o Language dysfunction (aphasic disorder, excluding dysarthria)
- •o Visual field defect (excluding monocular blindness)
- •o Extinction and Inattention (formerly Neglect)
- •An indication on routine diffusion-weighted magnetic resonance imaging (DW-MRI) or computed tomography perfusion scan at screening /baseline that the acute stroke involves the cerebral cortex
- •4) NIHSS larger > 5 and < 18 for left and right hemisphere strokes.
- •5) Age 18-85 years both inclusive.
- •6) Signed informed consent from patient or legally authorized representative or an independent witness or an independent physician, if applicable according to the Details about the consent procedure described in country-specific supplements to this protocol.
- •7) Subjects are indicated for the application of intravenous tPA (alteplase).
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 7
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 15
排除标准
- •2) Time interval since stroke onset of less than 3 hours is impossible to determine with high degree of confidence.
- •3) Symptoms suggestive of subarachnoid haemorrhage, even if CT or MRI scan is negative for haemorrhage.
- •7) Neurological deficit that has led to stupor or coma (NIHSS level of consciousness score greater than or equal to 2).
- •8) High clinical suspicion of septic embolus.
- •9) Minor stroke with non-disabling deficit or rapidly improving neurological symptoms in the absence of major vessel occlusion.
- •10) Baseline NIHSS greater than 18 for left and right hemisphere strokes.
- •11) Evidence of acute or chronic ICH by head CT or MRI.
- •14) Persistent hypertension with systolic BP greater than 185 mmHg or diastolic BP greater than 110 mmHg (mean of 3 consecutive arm cuff readings over 20-30 minutes), not controlled by antihypertensive therapy or requiring nitroprusside for control.
- •15) Blood glucose greater than 200 mg/dl.
- •18) Have suffered a stroke within 90 days of the screening/baseline assessments that is either diagnostically confirmed or assumed to be in the same cerebral territory as is the current acute stroke.
- •32) Subjects with disabling congestive heart failure (CHF) or unstable angina.
- •34) Subjects that suffered a myocardial infarction in the last 90 days.
- •47) Have a positive urine pregnancy test at screening/baseline or be a lactating female.
- •48) Any condition that in the investigator’s judgement precludes participation in the study.
研究者
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