Stroke | Paramedic Initiated Lisinopril For Acute Stroke Treatment
Stroke research study
What is the primary objective of this study?
This study aims to investigate the use of lisinopril to lower blood pressure in stroke patients, pre-hospital, by research-trained paramedics.
Who is eligible to participate?
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
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:Lisinopril5-10 mg Lisinopril per day for seven days, depending on blood pressure.
Drug:PlaceboMatched placebo; identical tablets to Lisinopril.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Start Date: October 2010
Completed Date: December 2011
Phase: Phase 1
Primary Outcome: Number of participants enrolled per month
Secondary Outcome: Proportion fulfilling eligibility criteria
Study sponsors, principal investigator, and references
Principal Investigator: Christopher Price
Lead Sponsor: Newcastle-upon-Tyne Hospitals NHS Trust
Collaborator: North East Ambulance Service NHS Trust