• Lisa Shaw, Christopher Price, Sally McLure, Denise Howel, Elaine McColl, and Gary A Ford.
• Institute for Ageing and Health (Stroke Research Group), Newcastle University, Newcastle upon Tyne, NE4 5PL, England, UK.
• Trials. 2011 Jan 1;12:152.

BackgroundHigh 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.MethodsTrial DesignDouble blind parallel group external pilot randomised controlled trial.SettingParticipant recruitment and initial treatment by North East Ambulance Service research trained paramedics responding to the emergency call. Continued treatment in three study hospitals.ParticipantsTarget 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).InterventionLisinopril 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.OutcomesStudy 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).DiscussionThis 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.Trial RegistrationEudraCT: 2010-019180-10ClinicalTrials.gov: NCT01066572ISRCTN: 54540667.

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