EUCTR2010-019180-10-GB进行中（未招募）不适用
Paramedic Initiated Lisinopril For Acute Stroke Treatment(PIL-FAST): A Pilot Randomised Controlled Trial - Paramedic Initiated Lisinopril for Acute Stroke Treatment (PIL-FAST)
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 60
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
- •Adults = 40 years old
- •New unilateral arm weakness thought to be due to acute stroke within 3 hours of symptom onset
- •Hypertension as defined by systolic BP >160mm Hg on two consecutive seated or lying readings taken 5 – 10 minutes apart
- •Conscious (eyes open spontaneously ie A” on Alert, Voice, Pain, Unresponsive (AVPU) scale)
- •Patient being transported to a PIL-FAST trial site (i.e. Royal Victoria Infirmary, North Tyneside General Hospital and Wansbeck General Hospital)
- •Verbal consent obtained from participant or next of kin
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Age < 40 years
- •Females who are pregnant, lactating or at risk of pregnancy (i.e. who are not surgically sterile or at least 1 year post last menstrual period). Females < 56 years of age consented by a relative will be excluded as menstrual history may be unknown
- •Any presentation of suspected stroke without unilateral arm weakness
- •Cannot establish that stroke onset time (ie when patient was last seen well without symptoms) was within the last 3 hours
- •Systolic BP < 160mm Hg
- •Reduced level of consciousness (below A” on AVPU scale)
- •Patient not being transported to PIL-FAST trial site
- •Absence of participant or next of kin consent
- •Known to be taking ACE-inhibitor or Angiotensin II Receptor Blocker medication already
- •Known sensitivity to lisinopril or other ACE-inhibitor medication
- •Pulse > 120 beats per minute
- •Seizure activity in this illness episode (witnessed or history)
- •Hypoglycaemia (blood glucose < 3.5 mmols/l)
- •Cannot walk independently prior to stroke (walking stick / frame is allowed)
- •Obvious understanding or memory problems when next of kin is absent
- •Significant head trauma or brain surgery in the last 3 months
- •Known renal failure
- •Known liver failure (or currently jaundiced)
- •Uncontrolled heart failure (breathlessness at rest)
- •Receiving palliative care for known malignancy
- •Currently enrolled in a clinical trial assessing a study drug
研究者
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