Paramedic Initiated Lisinopril For Acute Stroke

ISRCTN ISRCTN54540667
DOI https://doi.org/10.1186/ISRCTN54540667
ClinicalTrials.gov (NCT) NCT01066572
Protocol serial number NCTU5248
Sponsor Newcastle upon Tyne Hospitals NHS Foundation Trust (UK)
Funder National Institute for Health Research (NIHR) (UK) - Programme Grants for Applied Research (ref: RP-PG-0606-1241)
Submission date
23/09/2010
Registration date
10/01/2011
Last edited
04/10/2013
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Gary Ford
Scientific

Institute for Ageing and Health
The Medical School
Newcastle University
Newcastle upon Tyne
NE2 4HH
United Kingdom

Study information

Primary study designInterventional
Study designDouble blind parallel group pilot randomised controlled trial
Secondary study designRandomised controlled trial
Study type Participant information sheet
Scientific titleParamedic Initiated Lisinopril For Acute Stroke: a pilot, double blinded, randomised, placebo controlled trial
Study acronymPIL-FAST
Study objectivesThis 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(s)Newcastle and North Tyneside 2 Research Ethics Committee approved on the 19th August 2010 (ref: 10/H0907/33)
Health condition(s) or problem(s) studiedStroke with high blood pressure
Intervention5 - 10 mg Lisinopril or matched placebo, once per day for seven days.

The total duration of follow up will be 7 days.
Intervention typeOther
Primary outcome measure(s)

Number of participants enrolled in the study per month

Key secondary outcome measure(s)

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.

Completion date28/10/2011

Eligibility

Participant type(s)Patient
Age groupAdult
SexAll
Target sample size at registration60
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment29/10/2010
Date of final enrolment28/10/2011

Locations

Countries of recruitment

  • United Kingdom
  • England

Study participating centre

Institute for Ageing and Health
Newcastle upon Tyne
NE2 4HH
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/12/2014 Yes No
Protocol article protocol 15/06/2011 Yes No
HRA research summary 28/06/2023 No No
Participant information sheet Participant information sheet 11/11/2025 11/11/2025 No Yes
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