Paramedic Initiated Lisinopril For Acute Stroke Treatment (PIL-FAST)

Paramedic Initiated Lisinopril For Acute Stroke Treatment: a Pilot Randomised Controlled Trial

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

Study Overview

• Status: Completed
• Conditions: Stroke
• Intervention / Treatment: Drug: Lisinopril; Drug: Placebo

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 Type: Interventional
• Enrollment (Actual): 14
• Phase: Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • Northumberland
    • Ashington, Northumberland, United Kingdom, NE63 9JJ
      • Wansbeck General Hospital
  • Tyne and Wear
    • Newcastle upon Tyne, Tyne and Wear, United Kingdom, NE1 4LP
      • Royal Victoria Infirmary, Queen Victoria Road
    • Newcastle upon Tyne, Tyne and Wear, United Kingdom, NE15 8NY
      • North East Ambulance Service NHS Trust
    • North Shields, Tyne and Wear, United Kingdom, NE29 8NH
      • North Tyneside General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Placebo Comparator	Drug: Placebo; Matched placebo; identical tablets to Lisinopril.; Other Names: Dummy drug
Experimental: Lisinopril; Experimental	Drug: Lisinopril; 5-10 mg Lisinopril per day for seven days, depending on blood pressure.; Other Names: ACE inhibitor

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants enrolled per month	The primary outcome measure is the number of participants enrolled in the study per month.	1 year

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Newcastle-upon-Tyne Hospitals NHS Trust
• Collaborators: Northumbria Healthcare NHS Foundation Trust; North East Ambulance Service NHS Foundation Trust
• Investigators: Principal Investigator: Christopher Price, Northumbria Healthcare NHS Foundation Trust; Principal Investigator: Anand Dixit, Newcastle-upon-Tyne Hospitals NHS Trust; Principal Investigator: Ann Fox, North East Ambulance Service NHS Foundation Trust

Publications and helpful links

General Publications

• Shaw L, Price C, McLure S, Howel D, McColl E, Younger P, Ford GA. Paramedic Initiated Lisinopril For Acute Stroke Treatment (PIL-FAST): results from the pilot randomised controlled trial. Emerg Med J. 2014 Dec;31(12):994-9. doi: 10.1136/emermed-2013-202536. Epub 2013 Sep 27.
• Shaw L, Price C, McLure S, Howel D, McColl E, Ford GA. Paramedic Initiated Lisinopril For Acute Stroke Treatment (PIL-FAST): study protocol for a pilot randomised controlled trial. Trials. 2011 Jun 15;12:152. doi: 10.1186/1745-6215-12-152.

Study record dates

Study Major Dates

• Study Start: October 1, 2010
• Primary Completion (Actual): December 1, 2011
• Study Completion (Actual): December 1, 2011

Study Registration Dates

• First Submitted: February 9, 2010
• First Submitted That Met QC Criteria: February 9, 2010
• First Posted (Estimate): February 10, 2010

Study Record Updates

• Last Update Posted (Actual): March 30, 2017
• Last Update Submitted That Met QC Criteria: March 29, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Enzyme Inhibitors; Protease Inhibitors; Protective Agents; Cardiotonic Agents; Lisinopril; Angiotensin-Converting Enzyme Inhibitors
• Other Study ID Numbers: RP-PG-0606-1241

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: No IPD were shared, nor will be, from this trial.