Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT01066572
Protocol/serial number
NCTU5248
Study information
Scientific title
Paramedic Initiated Lisinopril For Acute Stroke: a pilot, double blinded, randomised, placebo controlled trial
Acronym
PIL-FAST
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
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Not available in web format, please contact Gillian Watson [gillian.watson@ncl.ac.uk] to request a patient information sheet
Condition
Stroke with high blood pressure
Intervention
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
Other
Phase
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
29/10/2010
Overall trial end date
28/10/2011
Reason abandoned (if study stopped)
Eligibility
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
Patient
Age group
Adult
Gender
Both
Target number of participants
60
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
29/10/2010
Recruitment end date
28/10/2011
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Institute for Ageing and Health
Newcastle upon Tyne
NE2 4HH
United Kingdom
Sponsor information
Organisation
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
NE1 4LP
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
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
Location
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: http://www.ncbi.nlm.nih.gov/pubmed/21676221
2. 2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/24078198
Publication citations
-
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.
-
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.