title: Paramedic Initiated Lisinopril For Acute Stroke Treatment (PIL-FAST): study protocol for a pilot randomised controlled trial.
abstract: BACKGROUND
  High blood pressure during acute stroke is associated with poorer stroke outcome. Previous trials have failed to show benefit from lowering blood pressure but treatment may have been commenced too late to be effective. The earliest that acute stroke treatments could be initiated is during contact with the emergency medical services (paramedics). However, experience of pre-hospital clinical trials is limited and logistical challenges are likely to be greater than for trials performed in other settings. We report the protocol for a pilot randomised controlled trial of paramedic initiated blood pressure lowering treatment for hypertension in acute stroke.
  
  
  METHODS
  
  
  
  METHODS
  Double blind parallel group external pilot randomised controlled trial.
  
  
  METHODS
  Participant recruitment and initial treatment by North East Ambulance Service research trained paramedics responding to the emergency call. Continued treatment in three study hospitals.
  
  
  METHODS
  Target is recruitment of 60 adults with acute arm weakness due to suspected stroke (within 3 hours of symptom onset) and hypertension (systolic BP>160 mmHg).
  
  
  METHODS
  Lisinopril 5-10 mg (intervention group), matched placebo (control group), daily for 7 days. Randomisation: Study medication contained within identical pre-randomised "trial packs" carried by research trained paramedics.
  
  
  RESULTS
  Study feasibility (recruitment rate, compliance with data collection) and clinical data to inform the design of a definitive randomised controlled trial (blood pressure monitoring, National Institute of Health Stroke Scale, Barthel ADL Index, Modified Rankin Scale, renal function).
  
  
  CONCLUSIONS
  This pilot study is assessing the feasibility of a randomised controlled trial of paramedic initiated lisinopril for hypertension early after the onset of acute stroke. The results will inform the design of a definitive RCT to evaluate the effects of very early blood pressure lowering in acute stroke.
  
  
  BACKGROUND
  EudraCT: 2010-019180-10ClinicalTrials.gov: NCT01066572ISRCTN: 54540667.
authors.affiliation: Institute for Ageing and Health (Stroke Research Group), Newcastle University, Newcastle upon Tyne, NE4 5PL, England, UK.
authors.forename: Lisa
authors.initials: L
authors.lastname: Shaw
authors.forename: Christopher
authors.initials: C
authors.lastname: Price
authors.forename: Sally
authors.initials: S
authors.lastname: McLure
authors.forename: Denise
authors.initials: D
authors.lastname: Howel
authors.forename: Elaine
authors.initials: E
authors.lastname: McColl
authors.forename: Gary A
authors.initials: GA
authors.lastname: Ford
mesh_terms: D000806:Angiotensin-Converting Enzyme Inhibitors / Q000008:administration & dosage*; D000959:Antihypertensive Agents / Q000008:administration & dosage*; D001794:Blood Pressure / Q000187:drug effects*; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D004632:Emergency Medical Services; D004634:Emergency Medical Technicians; D004739:England; D005240:Feasibility Studies; D006801:Humans; D017706:Lisinopril / Q000008:administration & dosage*; D010865:Pilot Projects; D012107:Research Design; D020521:Stroke / Q000188:drug therapy* / Q000503:physiopathology; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D000806:Angiotensin-Converting Enzyme Inhibitors; D000959:Antihypertensive Agents; D017706:Lisinopril