Imaging perfusion deficits and thrombolysis safety and efficacy in acute ischaemic stroke: the Third International Stroke Trial

Not Applicable

Completed

• Conditions: Acute ischaemic stroke; Circulatory System; Stroke

• Registration Number: ISRCTN25765518
• Lead Sponsor: niversity of Edinburgh (UK)

Brief Summary

2008 Other publications in http://www.ncbi.nlm.nih.gov/pubmed/17766429 validation of a prognostic model 2008 Protocol article in http://www.ncbi.nlm.nih.gov/pubmed/18559104 protocol 2011 Other publications in http://www.ncbi.nlm.nih.gov/pubmed/22129158 update 2012 Results article in http://www.ncbi.nlm.nih.gov/pubmed/22632908 results 2013 Results article in http://www.ncbi.nlm.nih.gov/pubmed/23791822 follow-up results 2014 Results article in http://www.ncbi.nlm.nih.gov/pubmed/24603072 results 2014 Results article in http://www.ncbi.nlm.nih.gov/pubmed/25642519 results 2014 Results article in http://www.ncbi.nlm.nih.gov/pubmed/25370587 results 2015 Results article in http://www.ncbi.nlm.nih.gov/pubmed/25287075 results 2015 Results article in http://www.ncbi.nlm.nih.gov/pubmed/25477225 results 2015 Results article in http://www.ncbi.nlm.nih.gov/pubmed/25613308 results 2015 Results article in http://www.ncbi.nlm.nih.gov/pubmed/25819484 results 2015 Results article in http://www.ncbi.nlm.nih.gov/pubmed/23336348 results 2016 Results article in http://www.ncbi.nlm.nih.gov/pubmed/27450474 results 2016 Results article in http://www.ncbi.nlm.nih.gov/pubmed/27895298 results 2017 Results article in https://www.ncbi.nlm.nih.gov/pubmed/28008093 results 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/34292119/ consent method results (added 23/07/2021)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2004-07-02
• Study Completion: 2010-03-31
• Last Update Posted: 2 August 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 3035

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of patients alive and independent at six months (Modified Rankin Scale score of 0, 1, or 2).

Secondary Outcome Measures

Name	Time	Method
<br> 1. Events within seven days:<br> 1.1. Deaths from any cause<br> 1.2. Symptomatic intracranial haemorrhage (fatal or non-fatal)<br> 1.3. Any intracranial haemorrhage (including asymptomatic bleeds on repeat computed tomography [CT])<br> 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)<br> 2. Status at six months:<br> 2.1. Number of patients dead from any cause within six months<br> 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)<br>