Paramedic Initiated Lisinopril For Acute Stroke Treatment

Phase 1

Completed

• Conditions: Stroke
• Interventions: Drug: Placebo; Drug: Lisinopril

• Registration Number: NCT01066572
• Lead Sponsor: Newcastle-upon-Tyne Hospitals NHS Trust

Brief Summary

This study aims to investigate the use of lisinopril to lower blood pressure in stroke patients, pre-hospital, by research-trained paramedics.

Detailed Description

High blood pressure immediately following stroke is common and related to poorer stroke functional outcome and death. Although treatment of high blood pressure is well established for thre prevention of stroke, it is unclear if high blood pressure observed immediately after stroke should be lowered.

Several previous clinical trials have lowered blood pressure in acute stroke but this has not resulted in improved stroke outcome. One reason for this may be because treatment was started too late after stroke occurred. There is rapid progression of brain injury following stroke and any stroke treatment may need to be started very early to have a beneficial effect. Previous trials started blood pressure lowering after patients arrived at hospital and this was usually a significant time after stroke occurred.

The earliest time after stroke that blood pressure treatment could be started is during contact with the emergency medical services (paramedics). This research study is a pilot double blind randomised controlled trial of paramedic initiated blood pressure treatment for patients with high blood pressure immediately after stroke.

Patients with high blood pressure and suspected acute stroke will be identified and offered the opportunity to participate in the study by research trained paramedics from the North East Ambulance Service NHS Trust. Patients who agree to participate in the study will receive either lisinopril (a common blood pressure lowering medication) or 'dummy' (placebo) treatments for seven days. The first dose of medication will be given by the paramedic in the ambulance. Subsequent tablets will be given in hospital. The effects of treatment will be monitored by measuring blood pressure, neurological outcome and adverse events.

All aspects of study feasibility including recruitment rates and compliance with data collection will be recorded. The study will run for one year and recruit 60 patients.

Study Timeline

• Study First Submitted: 2010-02-09
• Study First Submitted QC: 2010-02-09
• Study First Posted: 2010-02-10
• Study Start: 2010-10
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-29
• Last Update Posted: 2017-03-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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

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 (i.e. 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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo Comparator
Lisinopril	Lisinopril	Experimental

Primary Outcome Measures

Name	Time	Method
Number of participants enrolled per month	1 year	The primary outcome measure is the number of participants enrolled in the study per month.

Secondary Outcome Measures

Name	Time	Method
Additional time spent on scene	1 year	The additional time spent on scene by research trained paramedics to enrol a participant into the study.
Clinical outcome measures	1 year	Clinical outcome measures are blood pressure, neurological score, dependency score and renal function.
Proportion fulfilling eligibility criteria	1 year	The proportion of suspected acute stroke patients admitted to research sites during the trial duration who fulfilled the study eligibility criteria
Proportion completing study medication	1 year	The proportion of study participants with confirmed stroke who complete seven days of study medication.
Hospital staff compliance	1 year	Hospital staff compliance with study medication administration and data collection.
Proportion attended by research trained paramedic	1 year	The proportion of study eligible patients attended by a research trained paramedic
Proportion enrolled by research trained paramedic	1 year	The proportion of study eligible patients enrolled into the study by a researc trained paramedic
Proportion approached but not enrolled	1 year	The proportion of study eligible patients approached about the research study but not enrolled, and the reasons for non-enrolment, where possible.
Paramedic compliance	1 year	Paramedic compliance with study data collection.
Adverse events	1 year	Adverse events in control and intervention groups during the study.

Trial Locations

Locations (4)

Royal Victoria Infirmary, Queen Victoria Road; 🇬🇧 Newcastle upon Tyne, Tyne and Wear, United Kingdom

North East Ambulance Service NHS Trust; 🇬🇧 Newcastle upon Tyne, Tyne and Wear, United Kingdom

North Tyneside General Hospital; 🇬🇧 North Shields, Tyne and Wear, United Kingdom

Wansbeck General Hospital; 🇬🇧 Ashington, Northumberland, United Kingdom