Acute ischaemic stroke Circulatory System Stroke
Conditions
Interventions
In each collaborating hospital, the hospital co-ordinator will implement a written protocol for the immediate assessment of patients with suspected acute stroke. Patients will be 'fast-tracked' to the
Sponsors
University of Edinburgh (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients with mild, moderate or severe strokes are potentially eligible if the following criteria are met: 1. Symptoms and signs of clinically definite acute stroke 2. Time of stroke onset is known and treatment can be started within six hours of this onset 3. Computerised tomography (CT) or magnetic resonance imaging (MRI) brain scanning has reliably excluded both intracranial haemorrhage and structural brain lesions which can mimic stroke (e.g. cerebral tumour)
Exclusion criteria
Exclusion criteria: 1. The patient has previously been randomised in IST-3 2. Major surgery, trauma (e.g. major fall at time of stroke) or gastrointestinal or urinary tract haemorrhage within the previous 21 days 3. Any known defect in coagulation, e.g.: 3.1. Currently on oral anticoagulants with an International normalised ratio (INR) greater than 1.3, or 3.2. Current treatment with heparin (unless activated partial thromboplastin time [APPT] within normal laboratory limits), or 3.3. Treatment with low molecular weight heparin or heparinoid, or 3.4. Treatment with Ximelagatran 4. Known defect of clotting or plaelet function (but patients on antiplatelet agents can be randomised) 5. The patient is female and of childbearing potential (unless it is certain that pregnancy is not possible) or breastfeeding 6. Hypo- or hyperglycaemia sufficient to account for the neurological symptoms; the patient should be excluded if their blood glucose is less than 3.0 or greater than 20.0 mmol/L ('stick testing' is a sufficiently accurate test for this purpose) 7. Symptoms considered likely to resolve completely within the next few hours (i.e., a transient ischaemic attack [TIA]) 8. Patient has had a stroke within the previous 14 days or has had a treatment for acute ischaemic stroke with thrombolytic therapy within the past 14 days 9. Patient was already dependent in activities of daily living before the present acute stroke 10. Patient has other life threatening illness (e.g. advanced cancer) likely to lead to death within a few months 11. Likely to be unavailable for follow-up, e.g., no fixed home address 12. Patient has blood pressure less than 90 mmHg or greater than 220 mmHg or diastolic blood pressure less than 40 mmHg or greater than 130 mmHg
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients alive and independent at six months (Modified Rankin Scale score of 0, 1, or 2). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Events within seven days: 1.1. Deaths from any cause 1.2. Symptomatic intracranial haemorrhage (fatal or non-fatal) 1.3. Any intracranial haemorrhage (including asymptomatic bleeds on repeat computed tomography [CT]) 1.4. Severe extracranial haemorrhage (i.e. fatal, severe enough to require transfusion or operation, or an absolute decrease in haemoglobin greater than 5 g/dl, or a decrease in haematocrit of greater than 15%, or bleeding associated with persistent or serious disability) 2. Status at six months: 2.1. Number of patients dead from any cause within six months 2.2. Number of patients making a complete recovery, and those who are alive but dependent (defined by the questions used in IST), Health Related Quality of Life (HRQoL), measured with the postal questionnaire version of the European quality of life (EuroQol) | — |
Countries
Australia, Austria, Belgium, Canada, Italy, Norway, Poland, Sweden, United Kingdom
Outcome results
None listed