Adults with acute ischaemic stroke presenting in Emergency Departments and Stroke Units in the UK Circulatory System Hyperacute ischaemic stroke
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Current participant inclusion criteria as of 09/04/2025: 1. Acute ischaemic stroke 2. 4 at randomisation 5. Aged >18 years
Exclusion criteria
Exclusion criteria: Current participant exclusion criteria as of 09/04/2025: 1. Pre-morbid dependency (modified Rankin Scale, mRS>3) 2. Systolic BP =80 mmHg 3. Spontaneous intracerebral haemorrhage 4. Haemorrhagic transformation of infarction PH2 if known before randomisation (not excluded or withdrawn if occurs after randomisation) 5. Dementia - if the patient had a pre-existing diagnosis 6. Coma (GCS 3) 2. Systolic BP =80 mmHg 3. Spontaneous intracerebral haemorrhage 4. Haemorrhagic transformation of infarction PH2 if known before randomisation (not excluded or withdrawn if occurs after randomisation) 5. Dementia - if the patient had a pre-existing diagnosis 6. Coma (GCS 3) 2. Spontaneous intracerebral haemorrhage 3. Haemorrhagic transformation of infarction PH2 4. Dementia 5. Coma (GCS 3) 2. Spontaneous intracerebral haemorrhage 3. Dementia 4. Coma (GCS 3) 2. Spontaneous intracerebral haemorrhage 3. Dementia 4. Coma (GCS 7 days) nitrate therapy 10. Receiving treatment for diabetes 11. Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Death or dependency assessed by the modified Rankin Scale (mRS) ordinal shift analysis recorded using central blinded telephone follow-up at 90 days. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Adverse events including: death, neurological deterioration, intracranial haemorrhage, systemic embolism, and other serious adverse events measured through clinical assessment at 2 and 4 days, patient notes at discharge, and responses to central blinded telephone follow-up at 90 days 2. Cerebrovascular events measured through clinical assessment at 2 and 4 days, patient notes at discharge, and responses to central blinded telephone follow-up at 90 days 3. Major adverse cardiac and cerebral events measured through clinical assessment at 2 and 4 days, patient notes at discharge, and responses to central blinded telephone follow-up at 90 days 4. Acute kidney injury measured through clinical assessment at 2 and 4 days, patient notes at discharge, and responses to central blinded telephone follow-up at 90 days 5. Disability measured through responses to central blinded telephone follow-up at 90 days 6. Cognition measured through responses to central blinded telephone follow-up at 90 days 7. Mood measured through responses to central blinded telephone follow-up at 90 days 8. Frailty measured through responses to central blinded telephone follow-up at 90 days 9. Quality of life measured through responses to central blinded telephone follow-up at 90 days | — |
Countries
England, Northern Ireland, Scotland, United Kingdom, Wales