Paramedic Initiated Lisinopril For Acute Stroke Treatment

Stroke Clinical Trial

— PIL-FAST  

Official title:

Paramedic Initiated Lisinopril For Acute Stroke Treatment: a Pilot Randomised Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01066572
• Other study ID #: RP-PG-0606-1241
• Status: Completed
• Phase: Phase 1
• First received: February 9, 2010
• Last updated: March 29, 2017
• Start date: October 2010
• Est. completion date: December 2011

Study information

• Verified date: March 2017
• Source: Newcastle-upon-Tyne Hospitals NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aims to investigate the use of lisinopril to lower blood pressure in stroke patients, pre-hospital, by research-trained paramedics.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

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

Locations

Country	Name	City	State
United Kingdom	Wansbeck General Hospital	Ashington	Northumberland
United Kingdom	North East Ambulance Service NHS Trust	Newcastle upon Tyne	Tyne and Wear
United Kingdom	Royal Victoria Infirmary, Queen Victoria Road	Newcastle upon Tyne	Tyne and Wear
United Kingdom	North Tyneside General Hospital	North Shields	Tyne and Wear

Sponsors (3)

Lead Sponsor	Collaborator
Newcastle-upon-Tyne Hospitals NHS Trust	North East Ambulance Service NHS Trust, Northumbria Healthcare NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants enrolled per month	The primary outcome measure is the number of participants enrolled in the study per month.	1 year
Secondary	Proportion fulfilling eligibility criteria	The proportion of suspected acute stroke patients admitted to research sites during the trial duration who fulfilled the study eligibility criteria	1 year
Secondary	Proportion attended by research trained paramedic	The proportion of study eligible patients attended by a research trained paramedic	1 year
Secondary	Proportion enrolled by research trained paramedic	The proportion of study eligible patients enrolled into the study by a researc trained paramedic	1 year
Secondary	Proportion approached but not enrolled	The proportion of study eligible patients approached about the research study but not enrolled, and the reasons for non-enrolment, where possible.	1 year
Secondary	Additional time spent on scene	The additional time spent on scene by research trained paramedics to enrol a participant into the study.	1 year
Secondary	Paramedic compliance	Paramedic compliance with study data collection.	1 year
Secondary	Hospital staff compliance	Hospital staff compliance with study medication administration and data collection.	1 year
Secondary	Proportion completing study medication	The proportion of study participants with confirmed stroke who complete seven days of study medication.	1 year
Secondary	Clinical outcome measures	Clinical outcome measures are blood pressure, neurological score, dependency score and renal function.	1 year
Secondary	Adverse events	Adverse events in control and intervention groups during the study.	1 year