Condition category
Circulatory System
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information



Primary contact

Prof Gary Ford


Contact details

Institute for Ageing and Health
The Medical School
Newcastle University
Newcastle upon Tyne
United Kingdom

Additional identifiers

EudraCT number number


Protocol/serial number


Study information

Scientific title

Paramedic Initiated Lisinopril For Acute Stroke: a pilot, double blinded, randomised, placebo controlled trial



Study hypothesis

This study aims to assess the feasibility of a double blind parallel group randomised controlled trial of paramedic initiated treatment for patients with symptoms of recent stroke.

Ethics approval

Newcastle and North Tyneside 2 Research Ethics Committee approved on the 19th August 2010 (ref: 10/H0907/33)

Study design

Double blind parallel group pilot randomised controlled trial

Primary study design


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet

Not available in web format, please contact Gillian Watson [] to request a patient information sheet


Stroke with high blood pressure


5 - 10 mg Lisinopril or matched placebo, once per day for seven days.

The total duration of follow up will be 7 days.

Intervention type



Not Applicable

Drug names

Primary outcome measure

Number of participants enrolled in the study per month

Secondary outcome measures

1. The proportion of suspected acute stroke patients admitted to research sites during the trial duration who fulfilled the study eligibility criteria
2. The proportion of study eligibile patients attended by a research-trained paramedic
3. The proportion of study eligible patients enrolled into the study by a research-trained paramedic
4. The proportion of study eligible patients approached about the research study but not enrolled, and the reasons for non-enrolment where possible
5. The proportion of study eligible patients not approached about the research study, and the reasons for non-approach where possible
6. The additional time spent on scene by research-trained paramedics to enrol a participant into the study
7. Paramedic compliance with study data collection
8. Hospital staff compliance with study medication adminstration and data collection
9. The proportion of study participants with confirmed stroke who complete seven days of study medication
10. Clinical outcome measures are blood pressure, neurological score, dependency score and renal function
11. Adverse Events in control and intervention groups during the study

Outcomes will be assessed at baseline, 3 and 7 days.

Overall trial start date


Overall trial end date


Reason abandoned (if study stopped)


Participant inclusion criteria

1. Adults greater than or equal to 40 years old
2. New unilateral arm weakness thought to be due to acute stroke within 3 hours of symptom onset
3. Hypertension as defined by systolic blood pressure (SBP) greater than 160 mmHg on two consecutive seated or lying readings taken 5 - 10 minutes apart
4. Conscious (eyes open spontaneously i.e. 'A' on Alert, Voice, Pain, Unresponsive [AVPU] scale)
5. Patient being transported to a PIL-FAST trial site (i.e. Royal Victoria Infirmary, North Tyneside General Hospital and Wansbeck General Hospital)
6. Verbal consent obtained from participant or next of kin

Participant type


Age group




Target number of participants


Participant exclusion criteria

1. Aged less than 40 years
2. 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 less than 56 years of age consented by a relative will be excluded as menstrual history may be unknown.
3. Any presentation of suspected stroke without unilateral arm weakness
4. Cannot establish that stroke onset time (i.e. when patient was last seen well without s symptoms) was within the last 3 hours
5. SBP less than 160 mmHg
6. Reduced level of consciousness (below 'A' on AVPU scale)
7. Patient not being transported to PIL-FAST trial site
8. Absence of participant or next of kin consent
9. Known to be taking ACE-inhibitor or Angiotensin II Receptor Blocker medication already
10. Known sensitivity to lisinopril or other ACE-inhibitor medication
11. Pulse greater than 120 beats per minute
12. Seizure activity in this illness episode (witnessed or history)
13. Hypoglycaemia (blood glucose less than 3.5 mmol/l)
14. Cannot walk independently prior to stroke (walking stick/frame is allowed)
15. Obvious understanding or memory problems when next of kin is absent
16. Significant head trauma or brain surgery in the last 3 months
17. Known renal failure
18. Known liver failure (or currently jaundiced)
19. Uncontrolled heart failure (breathlessness at rest)
20. Receiving palliative care for known malignancy
21. Currently enrolled in a clinical trial assessing a study drug

Recruitment start date


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

Institute for Ageing and Health
Newcastle upon Tyne
United Kingdom

Sponsor information


Newcastle upon Tyne Hospitals NHS Foundation Trust (UK)

Sponsor details

Joint Research Office
Level 6 Leazes Wing
Royal Victoria Infirmary
Queen Victoria Road
Newcastle upon Tyne
United Kingdom

Sponsor type




Funder type


Funder name

National Institute for Health Research (NIHR) (UK) - Programme Grants for Applied Research (ref: RP-PG-0606-1241)

Alternative name(s)

Funding Body Type

Funding Body Subtype


Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Basic results (scientific)

Publication list

1. 2011 protocol in:
2. 2013 results in:

Publication citations

  1. Protocol

    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, 12, 152, doi: 10.1186/1745-6215-12-152.

  2. Results

    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, 2013, doi: 10.1136/emermed-2013-202536.

Additional files

Editorial Notes