NCT01600235Unknown3 期
Safety and Efficacy of Therapeutic Induced Hypertension in Patients With Acute Non-cardioembolic Ischemic Stroke: A Multicenter, Randomized, Open Label, Prospective, Phase 3 Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 入组人数
- 170
- 试验地点
- 1
- 主要终点
- Primary outcome
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of the induced hypertension using phenylephrine in patients with noncardioembolic ischemic stroke.
The investigators hypothesized that phenylephrine induced-hypertension can result in good clinical response without serious complications in patients with noncardioembolic ischemic stroke.
详细描述
See below
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
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with acute ischemic stroke confirmed by diffusion-weighted imaging (DWI) performed within 24 hours of symptom onset or symptom worsening(defined by a 2-point or more increase in NIH stroke scale (NIHSS)score including one or more increase in the motor score of affected upper and lower limbs in NIHSS during hospitalization or clear history of symptom worsening judged by investigator before hospitalization) confirmed by DWI performed within 24 hours of aggravation.
- •Baseline NIHSS score 4-18 points
- •Alert mental status
- •Newly developed paresis, aphasia, or neglect
排除标准
- •Patients underwent recanalization therapy
- •Systolic blood pressure >170 mmHg at baseline
- •Patients with history or at risk of hemorrhagic stroke
- •History of significant arrhythmia (e.g. atrial fibrillation)
- •Unable to perform MRI scans or undergo MRI scans > 24 hours of symptom onset or progression
- •Large cortical infarction on DWI (more than 1/2 of middle cerebral artery territory)
- •3 or more cortical microbleeds on gradient-echo MRI
- •Coronary artery disease, congestive heart failure, or hypertrophic cardiomyopathy
- •Anticoagulation therapy (phenylephrine group only)
- •Patients with high-risk cardioembolic sources
- •Cervical or cerebral artery dissection or unruptured aortic/cerebral arterial aneurysm
- •Decreased consciousness
- •Pregnant or Lactating patient
- •Seizure at stroke onset
- •Life expectancy < 6 months
- •Pre-stroke modified Rankin scale (mRS) >= 2
- •Patients without informed consent
研究组 & 干预措施
Phenylephrine
Experimental
Phenylephrine induced-hypertension arm
干预措施: Phenylephrine (Drug)
结局指标
主要结局
Primary outcome
时间窗: Day 0 and Day 7
2 points improvement in NIH stroke scale (NIHSS) between days 0 and 7
次要结局
- Minor safety outcome(From date of randomization until the date of first documented intracranial hemorrhage on follow-up MRI, or date of first documented side effects, whichever came first, assessed up to 3 months)
- Secondary efficacy outcome(Day 90 for 1, 2 and Day 7 for 3)
- Major safety outcome(From date of randomization until the date of first documented progression by intracranial hemorrhage or cerebral edema, date of myocardial infarction, or date of death from any cause, whichever came first, assessed up to 3 months)
研究者
Oh Young Bang
Associate Professor
Samsung Medical Center
研究点 (1)
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