Stroke Circulatory System Stroke, not specified as haemorrhage or infarction
Conditions
Interventions
Current intervention as of 19/05/2022:
Patients will be randomized (1:1) to receive either glyceryl trinitrate patches or sham patches. Randomization will be performed by the Nottingham Stroke Trials
ICH) and minimisation on age, severity, time, systolic blood pressure and candidate for or received reperfusion therapy. Patients, relatives, researchers and outcome assessors will be masked to treatm
Sponsors
University of Nottingham
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 19/05/2022: 1. Adults (aged =18 years) 2. Presentation compatible with hyperacute stroke syndrome 3. One or more of the following symptoms present at time of enrolment: Dysphasia, neglect (NIHSS 1-2), hemianopia (NIHSS 1-3), or limb weakness (NIHSS on affected arm and/or leg 1-4) 4. Treatment can be commenced between 3 and 5 h from onset of symptoms (for patients with wake-up stroke, treatment no more than 5 h after patient awakens) 5. Systolic BP =120 mmHg 6. If a CT/MR scan has already been performed, then it shows acute intracerebral haemorrhage or ischaemic stroke, or is normal. (If a CT scan has not been performed then it should be performed as soon as possible after treatment.) 7. For participants who lack capacity to consent for themselves and have no relative/friend available: Waiver of consent for treatment to ensure GTN given in 3- to 5-h time-window (and thrombolysis not delayed if ischaemic stroke) _____ Previous inclusion criteria: 1. 120 adults (=18 years old) with presentation compatible with stroke) 2. Treatment 3-5 hours post ictus (or from when last seen free of stroke symptoms) 3. Limb weakness at time of enrolment (NIHSS on affected are and/or leg 1-4) 4. Systolic blood pressure (=120 mmHg) 5. If a CT/MR scan has already been performed, then it shows acute intracerebral haemorrhage or ischaemic stroke, or is normal 6. Waiver of consent for treatment to ensure GTN given in 3-5 hour time-window (and thrombolysis not delayed if ischaemic stroke)
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 19/05/2022 (following amendment approved 18/05/2022): 1. mRS =4 2. Hypotension or shock (systolic <120 mmHg) 3. BP Glucose (BM stix or equivalent) <3 mmol/l 4. Glasgow coma scale =8 5. Witnessed seizure at presentation 6. Known life expectancy <6 months 7. Patient presenting with sensory symptoms only 8. Known stroke mimic, aneurysmal subarachnoid haemorrhage, or haemorrhage due to venous thrombosis 9. Known allergy to glyceryl trinitrate (Transiderm-Nitro) patch 10. Known sensitivity to Duoderm hydrocolloid dressing 11. Planned for palliative care only 12. Recent use of phosphodiesterase type 5 (PDE5) inhibitors, e.g., sildenafil (Viagra®) 13. If a CT/MR scan has already been performed, then it shows a non-stroke lesion that explains the acute presentation 14. Known previous enrolment in ENOS-2 _____ Previous exclusion criteria as of 03/09/2021 (following amendment approved 25/08/2021): 1. mRS =4 2. Glucose (BM stix or equivalent) <3 mmol/l 3. Glasgow coma scale =8 4. Witnessed seizure at presentation 5. Known life expectancy <6 months 6. Known stroke mimic, aneurysmal subarachnoid haemorrhage, or haemorrhage due to venous thrombosis 7. Systolic blood pressure <120 mmHg 8. Known allergy to glyceryl trinitrate (Transiderm-Nitro) patch 9. Known sensitivity to Duoderm hydrocolloid dressing 10. Planned for palliative care only 11. Known previous enrolment in ENOS-2 _____ Previous exclusion criteria: 1. Patient from a nursing home 2. Glucose (BM stix or equivalent) <3 mmol/l 3. Glasgow coma scale =8 4. Witnessed seizure at presentation 5. Known life expectancy <6 months 6. Known stroke mimic, aneurysmal subarachnoid haemorrhage, or haemorrhage due to venous thrombosis 7. Systolic blood pressure <120 mmHg 8. Known allergy to glyceryl trinitrate (Transiderm-Nitro) patch 9. Known sensitivity to Duoderm hydrocolloid dressing 10. Planned for palliative care only 11. Known previous enrolment in ENOS-2
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measures as of 26/05/2022: 1. Feasibility of recruitment assessed using recruitment data recorded throughout the 31 months of recruitment 2. Safety assessed using safety monitoring throughout the study _____ Previous primary outcome measure: The feasibility of recruiting 120 (100 ischaemic stroke/20 intra-cerebral haemorrhage) eligible stroke patients who consent to participate in the study within 12 months of the start date | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 26/05/2022: 1. Blood pressure measured using standard sphygmomanometer at baseline, Day 0 post treatment, Day 1 during treatment 2. Disability measured using the National Institutes of Health Stroke Scale (NIHSS) at baseline and Day 2 3. Feeding and dysphagia measured using the Dysphagia Severity Rating Scale (DSRS) at Day 2 4. Hospital utilisation (thrombectomy, hemicraniectomy surgery, hyperacute stroke unit, rehabilitation, physiotherapy, occupational therapy, speech and language therapy, ITU use) measured by review of medical notes at death/discharge 5. Functional ability measured using the modified Rankin scale (mRS) and Barthel index (BI) at Day 90 6. Cognition measured using the mini mental state examination (MMSE) at Day 90 7. Mood measured using the Zung Depression Scale (ZDS) at Day 90 8. Quality of life measured using EuroQoL (EQ5D) at Day 90 _____ Previous secondary outcome measures: 1. Blood pressure measured using standard sphygmomanometer at baseline, Day 0 post treatment, Day 1 during treatment 2. Disability measured using the National Institutes of Health Stroke Scale (NIHSS) at baseline and Day 2 3. Feeding and dysphagia measured using the Dysphagia Severity Rating Scale (DSRS) at Day 2 4. Hospital utilisation (thrombectomy, hemicraniectomy surgery, hyperacute stroke unit, rehabilitation, physiotherapy, occupational therapy, speech and language therapy, ITU use) measured by review of medical notes at death/discharge 5. Functional ability measured using the modified Rankin scale (mRS) and Barthel index (BI) at Day 90 and Day 365 6. Cognition measured using the mini mental state examination (MMSE) at Day 90 and Day 365 7. Mood measured using the Zung Depression Scale (ZDS) at Day 90 and Day 365 8. Quality of life measured using EurolQuol (EQ5D) at Day 90 and Day 365 | — |
Countries
England, United Kingdom
Contacts
Public ContactDiane Havard
Outcome results
None listed