Paramedic Initiated Lisinopril For Acute Stroke
| ISRCTN | ISRCTN54540667 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN54540667 |
| ClinicalTrials.gov number | NCT01066572 |
| Secondary identifying numbers | NCTU5248 |
- 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
Scientific
Institute for Ageing and Health
The Medical School
Newcastle University
Newcastle upon Tyne
NE2 4HH
United Kingdom
Study information
| Study design | Double blind parallel group pilot randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please contact Gillian Watson [gillian.watson@ncl.ac.uk] to request a patient information sheet |
| Scientific title | Paramedic Initiated Lisinopril For Acute Stroke: a pilot, double blinded, randomised, placebo controlled trial |
| Study acronym | PIL-FAST |
| Study objectives | 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(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) studied | 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 |
| 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 study start date | 29/10/2010 |
| Completion date | 28/10/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 60 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 29/10/2010 |
| Date of final enrolment | 28/10/2011 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Institute for Ageing and Health
Newcastle upon Tyne
NE2 4HH
United Kingdom
NE2 4HH
United Kingdom
Sponsor information
Newcastle upon Tyne Hospitals NHS Foundation Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Joint Research Office
Level 6 Leazes Wing
Royal Victoria Infirmary
Queen Victoria Road
Newcastle upon Tyne
NE1 4LP
England
United Kingdom
| Website | http://www.newcastle-hospitals.org.uk/ |
|---|---|
"ROR" |
https://ror.org/05p40t847 |
Funders
Funder type
Government
National Institute for Health Research (NIHR) (UK) - Programme Grants for Applied Research (ref: RP-PG-0606-1241)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 15/06/2011 | Yes | No | |
| Results article | results | 01/12/2014 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No |
