NCT01455935Unknown2 期
Wake up Symptomatic Stroke in Acute Brain Ischemia (WASSABI) Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Modified Rankin Scale (mRS)
研究概览
简要总结
The purpose of the trial is to study the safety and the effectiveness of using CT Perfusion studies as an indicator to treat stroke patients with unknown time of onset.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion Criteria: To be eligible for entry into this study, candidates must meet all of the following eligibility criteria at the time of Emergency Department presentation:
- •Age: 18-80 years old
- •Ischemic Wake Up Stroke (Unknown time of onset but less than 24 hours since last seen normal)
- •National Institute of Health Stroke Scale (NIHSS) 8-22
- •Evidence of penumbra on Computed Tomography Perfusion(CTP) as mentioned above
- •Alberta Stroke Program Early Computed Tomography (CT) Score (ASPECTS 7 or more)
- •Signed informed consent
排除标准
- •Exclusion Criteria: Potential study patients will be excluded from study entry if any of the following exclusion criteria exist at the time of screening:
- •Evidence of intracranial hemorrhage (Intracerebral hematoma, intraventricular hemorrhage, subarachnoid hemorrhage (SAH), epidural hemorrhage, acute or chronic subdural hematoma (SDH)) on the baseline CT
- •Historical Modified Rankin Scale (mRS) of ≥2
- •National Institute of Health Stroke Scale (NIHSS)<8 at the time of treatment
- •Positive pregnancy test in women at age of childbearing
- •Intracranial or intraspinal surgery within 3 months
- •Stroke or serious head injury within 3 months
- •History of intracranial hemorrhage
- •Uncontrolled hypertension at time of treatment (eg, >185 mm Hg systolic or >110 mm Hg diastolic)
- •Seizure at the onset of stroke
- •Active internal bleeding
- •Intracranial neoplasm
- •Arteriovenous malformation or aneurysm
- •Clinical presentation suggesting post-MI pericarditis
- •Known bleeding diathesis including but not limited to current use of oral anticoagulants producing an Internation normalized ratio (INR) >1.7
- •Internation normalized ratio (INR) >1.7
- •Administration of heparin within 48 hours preceding the onset of stroke with an elevated activated Partial Thromboplastin Time(aPTT) at presentation
- •Platelet count <100,000/mm
- •Major surgery within 2 weeks
- •GastroIntestinal (GI) or urinary tract hemorrhage within 3 weeks
- •Aggressive treatment required to lower blood pressure
- •Glucose level <50 or >400 mg/dL
- •Arterial puncture at a noncompressible site or lumbar puncture within 1 week
研究组 & 干预措施
Medical Therapy
Active Comparator
Current standard of care per the latest stroke guidelines
- Permissive Hypertension up to 220
- Antipletelets therapy:
- ASA 81 mg PO daily or
- Plavix 75 mg PO daily or
- Aggrenox 225mg PO twice daily
- Anti-inflammatory therapy:
- Lipitor 80 mg PO daily or
- Crestor 20 mg PO daily
干预措施: Anti-platelets and statin (Drug)
Intravenous Thrombolysis
Experimental
Full dose Intravenous thrombolysis
- 0.9 mg/kg
- Maximum dose is 90 mg
- 10% of the dose will be given over one minute
- 90% of the dose will be infused over 1 hour
- Admission to Neuro Intensive Care Unit(NICU) for 24 hours if no complications
- Neuro checks every 5 minutes during the infusion
- Neuro checks every hour after the infusion for 24 hours
干预措施: alteplase (Drug)
Intra-Arterial Therapy
Experimental
-Choice of therapy per experienced Endovascular surgeon and includes:
- Intra arterial Activase (Maximum dose of 22 mg)
- MERCI device (Maximum of 3 tries per device, no standard time frame for how long the procedure takes)
- PENUMBRA device (no standard time frame for how long the procedure takes)
干预措施: intra arterial intervention (Procedure)
结局指标
主要结局
Modified Rankin Scale (mRS)
时间窗: 90 days
Modified Rankin Scale (mRS) 90 days post treatment
次要结局
- National Institute of Health Stroke Scale (NIHSS)(30 Days)
- Modified Rankin Scale (mRS)(30 post treatment)
- Thrombolysis In Myocardial Infarction (TIMI) Flow(Pre - up to1 hour prior to procedure and post will be up to1 hour after completion of procedure)
- Thomboylsis in Cerebral Ischemia (TICI) flow(Pre - will be no more than 1 hour prior to procedure and post will be no more then 1 hour after completion of procedure)
- symptomatic intracranial Hemorrhage (ICH)(72 hours)
研究者
Tareq Kass-Hout
Chief Vascular/Neurology Resident in charge of stroke
Jacobs Neurological Institute
研究点 (1)
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