Hyperacute stroke - both ischaemic and haemorrhage MedDRA version: 22.1 Level: PT Classification code 10061256 Term: Ischaemic stroke System Organ Class: 10029205 - Nervous system disorders MedDRA version: 21.1 Level: PT Classification code 10019016 Term: Haemorrhagic stroke System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Trade Name: Transiderm-Nitro 5
Product Name: Transiderm-Nitro 5
Pharmaceutical Form: Transdermal patch
INN or Proposed INN: Nitroglycerin
Concentration unit: mg milligram(s)
Concentration type: equal
Sponsors
University of Nottingham
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • 100 adults (=18 years) with ischaemic stroke and compatible CT (MR) scan. • 20 adults (=18 years) with imaging-confirmed intracerebral haemorrhage (ICH) and maximum haematoma length 120 mmHg • Waiver of consent for treatment to ensure GTN given in 3-5 hour time-window (and thrombolysis not delayed if ischaemic stroke). Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 90
Exclusion criteria
Exclusion criteria: • Patient from a nursing home • Glucose (BM stix or equivalent) <3 mmol/l • Glasgow coma scale <8 • Witnessed seizure at presentation • Known life expectancy <6 months. • Known stroke mimic, aneurysmal subarachnoid haemorrhage, or haemorrhage due to venous thrombosis • Systolic blood pressure <120 mmHg • Known allergy to glyceryl trinitrate (Transiderm Nitro) patch • Known sensitivity to Duoderm hydrocolloid dressing • Pregnant or breast-feeding • Planned for palliative care only • Known previous enrolment in ENOS-2
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the feasibility of recruiting, randomising, and treating patients with GTN vs sham to inform a definitive trial;Secondary Objective: To determine signals of efficacy on whether GTN reduces disability, low mood, poor cognition and low quality of life To investigate whether there is a difference between the two groups in blood pressure measured over the two days of monitoring To investigate whether specific genetic characteristics are associated with outcome. Potential genetic markers include nitric oxide synthase polymorphisms but others will be studied as relevant in searches of the scientific literature To investigate whether there is a difference in blood biomarkers between the two groups and whether biomarkers may be associated with outcome. Potential biomarkers include S-100 / nitric oxide (NOx) / P-selectin but others will be studied as relevant in searches of the scientific literature ;Primary end point(s): The primary end point of the study is the feasibility of recruiting and treating 120 patients (100 IS, 20 ICH) between 3 and 5 hours after stroke.;Timepoint(s) of evaluation of this end point: At the end of the trial | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Hospital admission: • Neurological impairment (NIHSS) • Systolic and diastolic blood pressure, heart rate. • Proportion of participants with systolic blood pressure <185 mmHg. • Feeding and dysphagia (dysphagia severity rating scale) • Stroke lesion size on brain scan (non-contrast CT or T2 MR). • Amount of cerebral arterial patency on brain scan (CT or MR angiography). Hospital utilisation: • Open-label blood pressure lowering. • Intravenous thrombolysis. • Mechanical thrombectomy. • Hyperacute stroke unit. • Stroke Rehabilitation Unit. • Physiotherapy. • Occupational therapy. • Speech & language therapy. • Surgery for IS - Hemicraniectomy. • Surgery for ICH. • Days in intensive/critical care unit. At day 2: • Systolic and diastolic blood pressure, heart rate. At day 3: Radiological markers on plain brain scan (CT or MR) 3 • Infarct/haematoma size. • Hyper-attenuated artery sign. • Infarct swelling • Mass effect. • Secondary haemorrhagic transformation of infarct. At day 3: Biomarkers • Blood biomarkers (exact measures to be determined by literature review prior to measurement but examples include S-100, NOx and P-selectin). • Genetic markers (exact measures to be determined by literature review prior to measurement but examples include NO synthase polymorphisms). At day 3 (or discharge if sooner): • Neurological impairment (NIHSS). • Stroke recurrence. • Neurological deterioration from baseline (NIHSS =4 points, or =2 point increase in any domain). • Feeding and dysphagia (DSRS). At discharge/death • Length of stay in hospital. • Patient disposition. At day 90 by telephone (or post): • Dependency – modified Rankin Scale (primary end point at Day 90). • Disability/Activities of Daily Living - Barthel Index (BI). • Quality of life - Health Utility Status (HUS, derived from EuroQoL-5D), EQ-Visual Analogue Scale (EQ-VAS). • Cognition - telephone-MMSE, Telephone Interview Cognition Scale (TICS), animal naming. • Mood - Zung Depression Scal | — |
Countries
United Kingdom
Contacts
Public ContactPhilip Bath
University of Nottingham
Outcome results
None listed