Paramedic Initiated Lisinopril For Acute Stroke Treatment (PIL-FAST)
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Paramedic Initiated Lisinopril For Acute Stroke Treatment: a Pilot Randomised Controlled Trial|
- Number of participants enrolled per month [ Time Frame: 1 year ] [ Designated as safety issue: No ]The primary outcome measure is the number of participants enrolled in the study per month.
- Proportion fulfilling eligibility criteria [ Time Frame: 1 year ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]The proportion of study eligible patients attended by a research trained paramedic
- Proportion enrolled by research trained paramedic [ Time Frame: 1 year ] [ Designated as safety issue: No ]The proportion of study eligible patients enrolled into the study by a researc trained paramedic
- Proportion approached but not enrolled [ Time Frame: 1 year ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]The additional time spent on scene by research trained paramedics to enrol a participant into the study.
- Paramedic compliance [ Time Frame: 1 year ] [ Designated as safety issue: No ]Paramedic compliance with study data collection.
- Hospital staff compliance [ Time Frame: 1 year ] [ Designated as safety issue: No ]Hospital staff compliance with study medication administration and data collection.
- Proportion completing study medication [ Time Frame: 1 year ] [ Designated as safety issue: No ]The proportion of study participants with confirmed stroke who complete seven days of study medication.
- Clinical outcome measures [ Time Frame: 1 year ] [ Designated as safety issue: No ]Clinical outcome measures are blood pressure, neurological score, dependency score and renal function.
- Adverse events [ Time Frame: 1 year ] [ Designated as safety issue: No ]Adverse events in control and intervention groups during the study.
|Study Start Date:||October 2010|
|Study Completion Date:||December 2011|
|Primary Completion Date:||December 2011 (Final data collection date for primary outcome measure)|
5-10 mg Lisinopril per day for seven days, depending on blood pressure.
|Placebo Comparator: Placebo||
Matched placebo; identical tablets to Lisinopril.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01066572
|Wansbeck General Hospital|
|Ashington, Northumberland, United Kingdom, NE63 9JJ|
|North East Ambulance Service NHS Trust|
|Newcastle upon Tyne, Tyne and Wear, United Kingdom, NE15 8NY|
|Royal Victoria Infirmary, Queen Victoria Road|
|Newcastle upon Tyne, Tyne and Wear, United Kingdom, NE1 4LP|
|North Tyneside General Hospital|
|North Shields, Tyne and Wear, United Kingdom, NE29 8NH|
|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 Trust|