Paramedic Initiated Lisinopril For Acute Stroke Treatment(PIL-FAST): A Pilot Randomised Controlled Trial - Paramedic Initiated Lisinopril for Acute Stroke Treatment (PIL-FAST)

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 60

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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