The third international stroke trial (IST-3) of thrombolysis for acute ischaemic stroke

被引：78

作者：

Sandercock P. ^{[1
]}

Lindley R. ^{[2
]}

Wardlaw J. ^{[1
]}

Dennis M. ^{[1
]}

Lewis S. ^{[1
]}

Venables G. ^{[3
]}

Kobayashi A. ^{[4
]}

Czlonkowska A. ^{[5
]}

Berge E. ^{[6
]}

Slot K.B. ^{[6
]}

Murray V. ^{[7
]}

Peeters A. ^{[8
]}

Hankey G. ^{[9
]}

Matz K. ^{[10
]}

Brainin M. ^{[10
]}

Ricci S. ^{[11
]}

Celani M.G. ^{[11
]}

Righetti E. ^{[11
]}

Cantisani T. ^{[12
]}

Gubitz G. ^{[13
]}

Phillips S. ^{[13
]}

Arauz A. ^{[14
]}

Prasad K. ^{[15
]}

Correia M. ^{[16
]}

Lyrer P. ^{[17
]}

机构：

[1] The IST-3 Co-ordinating Centre, Neurosciences Trials Unit, Western General Hospital, Edinburgh EH4 2XU, Crewe Road

[2] The University of Sydney, Westmead Hospital (C24), The University of Sydney, Sydney

[3] Neurology Department, Sheffield Teaching Hospitals NHS Foundation Trust, Royal Hallamshire Hospital, Sheffield S10 2JF, Glossop Road

[4] 2nd Department of Neurology, Institute of Psychiatry and Neurology, 02-957 Warsaw

[5] Department of Experimental and Clinical Pharmacology, Medical University of Warsaw, 00-927 Warsaw

[6] Department of Internal Medicine, Ullevaal University Hospital

[7] Karolinska Institutet, Department of Clinical Sciences, Danderyd Hospital

[8] Service de Neurologie, Cliniques Universitaires Saint-Luc, 1200 Bruxelles

[9] Royal Perth Hospital, Perth, WA 6001, Wellington Street

[10] Landesklinikum Donauregion Tulln, Neurologische Abteilung, 3430 Tulln

[11] Ospedale Beato Giacoma Villa, 06062-Perugia, Citta della Pieve

[12] S C di Neurofisiopatologia, Azienda Ospedaliera di Perugia, Perugia

[13] Division of Neurology, Dalhousie University, Queen Elizabeth II Health Sciences Centre, Halifax, NS B3H 3A7

[14] Instituto Nacional de Neurologia, La Fama 14269 Mexico, DF

[15] Department of Neurology, Neurosciences Centre, All India Institute of Medical Sciences, Ansari Nagar

[16] Neurology Department, Hospital Geral de Santo Antonio, 4050 Porto, Largo Prof Abel Salazar

[17] Department of Neurology, University Hospital Basel, CH-4031 Basel

来源：

Trials | / 9卷 / 1期

基金：

英国医学研究理事会;

关键词：

Acute Stroke; Acute Ischaemic Stroke; Intracranial Haemorrhage; Stroke Onset; Stroke Service;

D O I：

10.1186/1745-6215-9-37

中图分类号：

学科分类号：

摘要：

Background: Intravenous recombinant tissue plasminogen activator (rt-PA) is approved for use in selected patients with ischaemic stroke within 3 hours of symptom onset. IST-3 seeks to determine whether a wider range of patients may benefit. Design: International, multi-centre, prospective, randomized, open, blinded endpoint (PROBE) trial of intravenous rt-PA in acute ischaemic stroke. Suitable patients must be assessed and able to start treatment within 6 hours of developing symptoms, and brain imaging must have excluded intracerebral haemorrhage. With 1000 patients, the trial can detect a 7% absolute difference in the primary outcome. With3500 patients, it can detect a 4.0% absolute benefit & with 6000, (mostly treated between 3 & 6 hours), it can detect a 3% benefit. Trial procedures: Patients are entered into the trial by telephoning a fast, secure computerised central randomisation system or via a secure web interface. Repeat brain imaging must be performed at 24-48 hours. The scans are reviewed 'blind' by expert readers. The primary measure of outcome is the proportion of patients alive and independent (Modified Rankin 0-2) at six months (assessed via a postal questionnaire mailed directly to the patient). Secondary outcomes include: Events within 7 days (death, recurrent stroke, symptomatic intracranial haemorrhage), outcome at six months (death, functional status, EuroQol). © 2008 Sandercock et al; licensee BioMed Central Ltd.

引用

共 48 条

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