Paramedic Initiated Lisinopril For Acute Stroke Treatment "PIL-FAST"

Completed

Phase 1 Results N/A

Trial Description

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.

Conditions

Interventions

  • Placebo Drug
    Intervention Desc: Matched placebo; identical tablets to Lisinopril.
    ARM 1: Kind: Experimental
    Label: Placebo
  • Lisinopril Drug
    Other Names: ACE inhibitor
    Intervention Desc: 5-10 mg Lisinopril per day for seven days, depending on blood pressure.
    ARM 1: Kind: Experimental
    Label: Lisinopril

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Number of participants enrolled per month 1 year No
Secondary Proportion fulfilling eligibility criteria 1 year No
Secondary Proportion attended by research trained paramedic 1 year No
Secondary Proportion enrolled by research trained paramedic 1 year No
Secondary Proportion approached but not enrolled 1 year No
Secondary Additional time spent on scene 1 year No
Secondary Paramedic compliance 1 year No
Secondary Hospital staff compliance 1 year No
Secondary Proportion completing study medication 1 year No
Secondary Clinical outcome measures 1 year No
Secondary Adverse events 1 year No

Sponsors