Hypertension in acute stroke MedDRA version: 9.1 Level: LLT Classification code 10020772 Term: Hypertension
Conditions
Interventions
Trade Name: Nitro-Dur 0.2mg/hr
Product Name: glyceryl trinitrate
Pharmaceutical Form: Transdermal patch
CAS Number: 55-63-0
Sponsors
University of Nottingham
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Adult patients; >40 years of age • Paramedic assessment of stroke on basis of positive ‘Face & Arm weakness & Speech abnormality Test (FAST) in the context of a call to a patient with a ‘possible acute stroke’; • Event 140 mmHg). 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: • No consent/assent is available • GTN is indicated (e.g. concurrent angina) • GTN is contraindicated (e.g. dehydration, hypovolaemia); • Age 2)30 • Hypoglycaemia (if glucose tested). • Patients from a nursing home
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): N/A;Main Objective: • Effects of GTN on BP at 2 hours post treatment. [This outcome represents the sum of the trial, i.e. ability to identify, recruit, randomise, treat, and make measurements in patients presumed stroke in an ambulance, and hand them over to hospital staff. The 2 hour time reflects the time to peak effect for GTN.];Secondary Objective: •Proportions of patients i) randomised:approached about joining; ii) randomised:carried in ambulance; iii) treated according to protocol:all randomised (diagnostic accuracy); iv) reasons for not enrolling •Times from ictus to randomisation in ambulance; ictus to ED arrival, randomisation to ED arrival •Paramedics: Interview on experience and views; audit of routine care •Haemodynamic effects of GTN: on BP, HR and derivatives prior to ED arrival and at 2 hours •SSS at 2 hours; daily BP/HR/PP/RPP over 7 days; rates of headache, hypotension/hypertension needing intervention •Death; SSS; death/deterioration; recurrence-progression; symptomatic intracranial events; major extracranial haemorrhage; final diagnosis •Length of stay in hospital; discharge disposition. 90 days: Death; death or dependency mRS>2; disability Barthel Index; quality of life EuroQoL; cognition MMSE; mood Zung; •To assess the effects of GTN on surrogate marker of efficacy in the blood | — |
Countries
United Kingdom
Outcome results
None listed