Stroke and high blood pressure
Conditions
Interventions
Trade Name: Lisinopril-ratiopharm
Product Name: Lisinopril
Pharmaceutical Form: Tablet
Sponsors
The Newcastle upon Tyne Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Age 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The principal research objective is to demonstrate that recruitment into the trial is possible (we would like to demonstrate enrolment of at least four patients per month).;Secondary Objective: To report the proportion of suspected acute stroke patients admitted to research sites during the trial duration who fulfilled the study eligibility criteria. To report the proportion of study eligible patients attended by a research-trained paramedic. To report the proportion of study eligible patients enrolled into the study by a research-trained paramedic. To report the proportion of study eligible patients approached about the research study but not enrolled, and to report reasons for non-enrolment where possible. To report the proportion of study eligible patients not approached about the research study, and to report reasons for non-approach where possible. To determine the additional time spent on scene by research-trained paramedics to enrol a participant into the study. To report paramedic compliance with study data collection. To report hospital staff compliance with study medication administration and data collection. To report the proportion of study;Primary end point(s): The primary outcome measure is the number of participants enrolled in the study per month. | — |
Countries
United Kingdom
Outcome results
None listed