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

• ClinicalTrials.gov Identifier: NCT01066572
• Recruitment Status: Completed
• First Posted: February 10, 2010
• Last Update Posted: March 30, 2017
• Sponsor: Newcastle-upon-Tyne Hospitals NHS Trust
• Collaborators: North East Ambulance Service NHS Foundation Trust; Northumbria Healthcare NHS Foundation Trust
• Information provided by (Responsible Party): Newcastle-upon-Tyne Hospitals NHS Trust

Tracking Information

• First Submitted Date: February 9, 2010
• First Posted Date: February 10, 2010
• Last Update Posted Date: March 30, 2017
• Study Start Date: October 2010
• Actual Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 8, 2010)

Number of participants enrolled per month [ Time Frame: 1 year ]

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

• Original Primary Outcome Measures: Not Provided

Current Secondary Outcome Measures (submitted: June 8, 2010)

• Proportion fulfilling eligibility criteria [ Time Frame: 1 year ]
  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 [ Time Frame: 1 year ]
  The proportion of study eligible patients attended by a research trained paramedic
• Proportion enrolled by research trained paramedic [ Time Frame: 1 year ]
  The proportion of study eligible patients enrolled into the study by a researc trained paramedic
• Proportion approached but not enrolled [ Time Frame: 1 year ]
  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 [ Time Frame: 1 year ]
  The additional time spent on scene by research trained paramedics to enrol a participant into the study.
• Paramedic compliance [ Time Frame: 1 year ]
  Paramedic compliance with study data collection.
• Hospital staff compliance [ Time Frame: 1 year ]
  Hospital staff compliance with study medication administration and data collection.
• Proportion completing study medication [ Time Frame: 1 year ]
  The proportion of study participants with confirmed stroke who complete seven days of study medication.
• Clinical outcome measures [ Time Frame: 1 year ]
  Clinical outcome measures are blood pressure, neurological score, dependency score and renal function.
• Adverse events [ Time Frame: 1 year ]
  Adverse events in control and intervention groups during the study.

• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Paramedic Initiated Lisinopril For Acute Stroke Treatment
• Official Title: Paramedic Initiated Lisinopril For Acute Stroke Treatment: a Pilot Randomised Controlled Trial
• 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.

• Study Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Stroke

Intervention

• Drug: Lisinopril
  5-10 mg Lisinopril per day for seven days, depending on blood pressure.
  Other Name: ACE inhibitor
• Drug: Placebo
  Matched placebo; identical tablets to Lisinopril.
  Other Name: Dummy drug

Study Arms

• Experimental: Lisinopril
  Experimental
  Intervention: Drug: Lisinopril
• Placebo Comparator: Placebo
  Placebo Comparator
  Intervention: Drug: Placebo

Publications *

• 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.
• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: October 7, 2015): 14
• Original Enrollment: Not Provided
• Actual Study Completion Date: December 2011
• Actual Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 40 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United Kingdom

Administrative Information

• NCT Number: NCT01066572
• Other Study ID Numbers: RP-PG-0606-1241
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: No
• Plan Description: No IPD were shared, nor will be, from this trial.

• Current Responsible Party: Newcastle-upon-Tyne Hospitals NHS Trust
• Original Responsible Party: Ms Amanda Tortice, The Newcastle upon Tyne Hospitals NHS Foundation Trust
• Current Study Sponsor: Newcastle-upon-Tyne Hospitals NHS Trust
• Original Study Sponsor: Same as current

Collaborators

• North East Ambulance Service NHS Foundation Trust
• Northumbria Healthcare NHS Foundation Trust

Investigators

• Principal Investigator: Christopher Price; Northumbria Healthcare NHS Foundation Trust
• Principal Investigator: Anand Dixit; Newcastle-upon-Tyne Hospitals NHS Trust
• Principal Investigator: Ann Fox; North East Ambulance Service NHS Foundation Trust

• PRS Account: Newcastle-upon-Tyne Hospitals NHS Trust
• Verification Date: March 2017