Intensive Ambulance-delivered Blood Pressure Reduction in Hyper-Acute Stroke Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 2,425
- 试验地点
- 4
- 主要终点
- level of physical function
研究概览
简要总结
A multicentre, ambulance-delivered, prospective, randomized, open-label, blinded endpoint (PROBE) study to assess the effects of hyperacute intensive blood pressure (BP) lowering initiated in ambulance setting on (i) functional outcome in patients with acute stroke (ii) safety in patients with confirmed acute stroke and other conditions that were initially suspected as acute stroke (i.e. stroke mimic).
详细描述
As an investigator initiated and conducted, multicentre, ambulance-delivered, prospective, randomised, open-label, blinded outcome (PROBE) study. INTERACT4 aims to evaluate the effects of functional outcome according to an ordinal analysis of the full range of scores on the mRS, the safety in all randomised patients; reperfusion treatment (thrombolysis and/or thrombectomy) related symptomatic ICH (sICH, according to standard definitions), infarct size, the time to and overall rate of reperfusion treatment in AIS patients; hematoma volume and early expansion in ICH.
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
- Single (Outcomes Assessor)
盲法说明
Outcome assessor is independent of the treatment team
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age ≥18 years;
- •Acute syndrome that is due to presumed acute stroke, defined as FAST（Face, Arm, Speech, Time） scores of ≥2 with an arm motor deficit and time ≤2 hours from last seen well;
- •Systolic BP ≥150
- •Able to provide brief informed consent (if a waver of consent is not approved by the ethics committee)
排除标准
- •Coma - no response to tactile stimuli or verbal stimuli;
- •Severe co-morbid disease (e.g. cancer, chronic airflow disease, severe dementia,severe heart failure,pre-stroke disability[needed help]);
- •History of epilepsy or seizure at onset;
- •History of recent head injury (<7 days);
- •Hypoglycemia(glucose<2.8mmol/L)
研究组 & 干预措施
Intervention group
If systolic blood pressure>180:IV Urapidil 25mg If systolic blood pressure>150 (or 5 mins after first bolus) : IV Urapidil 25mg and to maintain this level after admission to hospital in those with confirmed acute stroke for the next 7 days (or hospital discharge if earlier)
干预措施: urapidil (Drug)
结局指标
主要结局
level of physical function
时间窗: Day 90
Level of function defined across 7 categories of disability on the modified Rankin scale （mRS 0-6) in which scores of 0 or 1 indicate good function without or with symptoms but not disability, socress of 2 indicates slight disability but independence, 3 to 5 indicate increasing levels of disability (and dependency), and a score of 6 indicates death.
次要结局
- number of patients with serious adverse events(Day 90)
- number of patients with any intracranial hemorrhage(Day 7)
- size of cerebral infarction(Day 2)
- number of patients who receive reperfusion treatment(Day 0)
- time to use of reperfusion treatment(Day 0)
- size of hematoma volume(Day 0)
- death or major disability(Day 90)
- Death(Day 90)
- death or dependency measured by a shift in NIHSS(day 1 and day 7)
- Disability(Day 90)
- Health related quality of life(day 90)
研究者
Craig Anderson
Director, Global Brain Health program
The George Institute for Global Health, China