Efficacy of Nitric Oxide in Stroke-2

Recruitment & Eligibility

Status: Ongoing

Sex: All

Target Recruitment: 120

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)

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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

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
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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

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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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Current primary outcome measures as of 26/05/2022:<br>1. Feasibility of recruitment assessed using recruitment data recorded throughout the 31 months of recruitment<br>2. Safety assessed using safety monitoring throughout the study<br><br>_____<br><br>Previous primary outcome measure:<br>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 Outcome Measures

Name	Time	Method

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