search
Back to results

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

Primary Purpose

Stroke

Status
Completed
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
Lisinopril
Placebo
Sponsored by
Newcastle-upon-Tyne Hospitals NHS Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Wansbeck General Hospital
  • Royal Victoria Infirmary, Queen Victoria Road
  • North East Ambulance Service NHS Trust
  • North Tyneside General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Lisinopril

Placebo

Arm Description

Experimental

Placebo Comparator

Outcomes

Primary Outcome Measures

Number of participants enrolled per month
The primary outcome measure is the number of participants enrolled in the study per month.

Secondary Outcome Measures

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
Proportion attended by research trained paramedic
The proportion of study eligible patients attended by a research trained paramedic
Proportion enrolled by research trained paramedic
The proportion of study eligible patients enrolled into the study by a researc trained paramedic
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.
Additional time spent on scene
The additional time spent on scene by research trained paramedics to enrol a participant into the study.
Paramedic compliance
Paramedic compliance with study data collection.
Hospital staff compliance
Hospital staff compliance with study medication administration and data collection.
Proportion completing study medication
The proportion of study participants with confirmed stroke who complete seven days of study medication.
Clinical outcome measures
Clinical outcome measures are blood pressure, neurological score, dependency score and renal function.
Adverse events
Adverse events in control and intervention groups during the study.

Full Information

First Posted
February 9, 2010
Last Updated
March 29, 2017
Sponsor
Newcastle-upon-Tyne Hospitals NHS Trust
Collaborators
North East Ambulance Service NHS Foundation Trust, Northumbria Healthcare NHS Foundation Trust
search

1. Study Identification

Unique Protocol Identification Number
NCT01066572
Brief Title
Paramedic Initiated Lisinopril For Acute Stroke Treatment
Acronym
PIL-FAST
Official Title
Paramedic Initiated Lisinopril For Acute Stroke Treatment: a Pilot Randomised Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Newcastle-upon-Tyne Hospitals NHS Trust
Collaborators
North East Ambulance Service NHS Foundation Trust, Northumbria Healthcare NHS Foundation Trust

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lisinopril
Arm Type
Experimental
Arm Description
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Lisinopril
Other Intervention Name(s)
ACE inhibitor
Intervention Description
5-10 mg Lisinopril per day for seven days, depending on blood pressure.
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Dummy drug
Intervention Description
Matched placebo; identical tablets to Lisinopril.
Primary Outcome Measure Information:
Title
Number of participants enrolled per month
Description
The primary outcome measure is the number of participants enrolled in the study per month.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Proportion fulfilling eligibility criteria
Description
The proportion of suspected acute stroke patients admitted to research sites during the trial duration who fulfilled the study eligibility criteria
Time Frame
1 year
Title
Proportion attended by research trained paramedic
Description
The proportion of study eligible patients attended by a research trained paramedic
Time Frame
1 year
Title
Proportion enrolled by research trained paramedic
Description
The proportion of study eligible patients enrolled into the study by a researc trained paramedic
Time Frame
1 year
Title
Proportion approached but not enrolled
Description
The proportion of study eligible patients approached about the research study but not enrolled, and the reasons for non-enrolment, where possible.
Time Frame
1 year
Title
Additional time spent on scene
Description
The additional time spent on scene by research trained paramedics to enrol a participant into the study.
Time Frame
1 year
Title
Paramedic compliance
Description
Paramedic compliance with study data collection.
Time Frame
1 year
Title
Hospital staff compliance
Description
Hospital staff compliance with study medication administration and data collection.
Time Frame
1 year
Title
Proportion completing study medication
Description
The proportion of study participants with confirmed stroke who complete seven days of study medication.
Time Frame
1 year
Title
Clinical outcome measures
Description
Clinical outcome measures are blood pressure, neurological score, dependency score and renal function.
Time Frame
1 year
Title
Adverse events
Description
Adverse events in control and intervention groups during the study.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher Price
Organizational Affiliation
Northumbria Healthcare NHS Foundation Trust
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Anand Dixit
Organizational Affiliation
Newcastle-upon-Tyne Hospitals NHS Trust
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ann Fox
Organizational Affiliation
North East Ambulance Service NHS Foundation Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wansbeck General Hospital
City
Ashington
State/Province
Northumberland
ZIP/Postal Code
NE63 9JJ
Country
United Kingdom
Facility Name
Royal Victoria Infirmary, Queen Victoria Road
City
Newcastle upon Tyne
State/Province
Tyne and Wear
ZIP/Postal Code
NE1 4LP
Country
United Kingdom
Facility Name
North East Ambulance Service NHS Trust
City
Newcastle upon Tyne
State/Province
Tyne and Wear
ZIP/Postal Code
NE15 8NY
Country
United Kingdom
Facility Name
North Tyneside General Hospital
City
North Shields
State/Province
Tyne and Wear
ZIP/Postal Code
NE29 8NH
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No IPD were shared, nor will be, from this trial.
Citations:
PubMed Identifier
24078198
Citation
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.
Results Reference
derived
PubMed Identifier
21676221
Citation
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.
Results Reference
derived

Learn more about this trial

Paramedic Initiated Lisinopril For Acute Stroke Treatment

We'll reach out to this number within 24 hrs