The Third International Stroke Trial (IST-3) of thrombolysis for acute ischaemic stroke: an international multicentre, randomised, controlled trial to investigate the safety and efficacy of treatment with intravenous recombinant tissue plasminogen activator (rt-PA) within six hours of onset of acute ischaemic stroke
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 3,035
研究概览
简要总结
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)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •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)
排除标准
- •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