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

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Sandercock, Peter Lindley, Richard Wardlaw, Joanna Dennis, Martin Lewis, Steff Peeters, André [UCL] Lyrer, Phillippe

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).

Document type Article de périodique (Journal article) – Article de recherche
Access type Accès restreint
Publication date 2008
Language Anglais
Journal information "Trials" - Vol. 9, no. 17, p. [1-17] (2008)
Peer reviewed yes
Publisher Biomed Central Ltd (London)
issn 1745-6215
Publication status Publié
Affiliation UCL - (SLuc) Service de neurologie
Links
  1. Murray CJL, Lopez AD: The Global Burden of Disease: a comprehensive assessment of mortality and disability from diseases, injuries and risk factors in 1990 and projected to 2020. 1996, Boston: Harvard University Press
  2. Asplund Kjell, Stroke in Europe: Widening Gap between East and West, 10.1159/000107983
  3. Chen Z., Sandercock P., Pan H., Counsell C., Collins R., Liu L., Xie J., Warlow C., Peto R., Indications for Early Aspirin Use in Acute Ischemic Stroke : A Combined Analysis of 40 000 Randomized Patients From the Chinese Acute Stroke Trial and the International Stroke Trial, 10.1161/01.str.31.6.1240
  4. Tissue Plasminogen Activator for Acute Ischemic Stroke, 10.1056/nejm199512143332401
  5. Hacke Werner, Intravenous Thrombolysis With Recombinant Tissue Plasminogen Activator for Acute Hemispheric Stroke : The European Cooperative Acute Stroke Study (ECASS), 10.1001/jama.1995.03530130023023
  6. Hacke Werner, Kaste Markku, Fieschi Cesare, von Kummer Rüdiger, Davalos Antoni, Meier Dieter, Larrue Vincent, Bluhmki Erich, Davis Stephen, Donnan Geoffrey, Schneider Dietmar, Diez-Tejedor Exuperio, Trouillas Paul, Randomised double-blind placebo-controlled trial of thrombolytic therapy with intravenous alteplase in acute ischaemic stroke (ECASS II), 10.1016/s0140-6736(98)08020-9
  7. Clark Wayne M., Wissman Stanley, Albers Gregory W., Jhamandas Jack H., Madden Kenneth P., Hamilton Scott, for the ATLANTIS Study Investigators, Recombinant Tissue-Type Plasminogen Activator (Alteplase) for Ischemic Stroke 3 to 5 Hours After Symptom Onset : The ATLANTIS Study: A Randomized Controlled Trial, 10.1001/jama.282.21.2019
  8. Albers GW, Clark WM, Madden KP, Hamilton SA: The ATLANTIS T-PA Acute Stroke Trial: results for patients treated within three hours of stroke onset. Stroke. 2000, 31 (1): 307-
  9. Wardlaw JM, del Zoppo G, Yamaguchi T, Berge E: Thrombolysis for acute ischaemic stroke (Cochrane Review). The Cochrane Library. 2003, Oxford, Update Software, 3
  10. Association of outcome with early stroke treatment: pooled analysis of ATLANTIS, ECASS, and NINDS rt-PA stroke trials, 10.1016/s0140-6736(04)15692-4
  11. Albers GW, Clark WM, for the ATLANTIS Study Investigators: The ATLANTIS rt-PA (Alteplase) acute stroke trial: final results. Cerebrovascular Diseases. 1999, 9 (Suppl 1): 126-
  12. Donnan G, Davis SM: When is enough enough?. Stroke. 2001, 32: 2710-2711.
  13. Lindley R: Further Randomized Controlled Trials of Tissue Plasminogen Activator Within 3 Hours Are Required. Stroke. 2001, 32: 2708-2709.
  14. Lyden P. D., Lu M., Levine S. R., Brott T. G., Broderick J., Cote R., A Modified National Institutes of Health Stroke Scale for Use in Stroke Clinical Trials : Preliminary Reliability and Validity Editorial Comment : The NIH Stroke Scale: Is Simpler Better?, 10.1161/01.str.32.6.1310
  15. Reed S. D., Cramer S. C., Blough D. K., Meyer K., Jarvik J. G., Wang D. Z., Treatment With Tissue Plasminogen Activator and Inpatient Mortality Rates for Patients With Ischemic Stroke Treated in Community Hospitals Editorial Comment, 10.1161/01.str.32.8.1832
  16. Johnston S. C., Fung L. H., Gillum L. A., Smith W. S., Brass L. M., Lichtman J. H., Brown A. N., Wang D. Z., Utilization of Intravenous Tissue-Type Plasminogen Activator for Ischemic Stroke at Academic Medical Centers : The Influence of Ethnicity Editorial Comment : It Is Time to Implement Stroke Practice Improvement Programs and Prevent the Racial Disparity in Stroke Care, 10.1161/01.str.32.5.1061
  17. Horowitz Steven H., Thrombolytic Therapy in Acute Stroke : Neurologists, Get Off Your Hands!, 10.1001/archneur.55.2.155
  18. Kaste Markku, Approval of alteplase in Europe: will it change stroke management?, 10.1016/s1474-4422(03)00343-0
  19. Canadian Association of Emergency Physicians Committee on Thrombolytic Therapy for Acute Ischemic Stroke: Thrombolytic therapy for acute ischemic stroke. Canadian Journal of Emergency Medicine. 2001, 3: 8-12.
  20. Goyal DG, Li J, Mann J, Schriger DL: American Academy of Emergency Physicians position statement on the use of intravenous thrombolytic therapy in the treatment of stroke. 2003, http://www.aaem.org/positionstatements/thrombolytictherapy.php
  21. Should Thrombolytic Therapy Be the First-Line Treatment for Acute Ischemic Stroke?, 10.1056/nejm199710303371812
  22. Adams H. P., Adams R. J., Brott T., del Zoppo G. J., Furlan A., Goldstein L. B., Grubb R. L., Higashida R., Kidwell C., Kwiatkowski T. G., Marler J. R., Hademenos G. J., Guidelines for the Early Management of Patients With Ischemic Stroke: A Scientific Statement From the Stroke Council of the American Stroke Association, 10.1161/01.str.0000064841.47697.22
  23. Sandercock P., Berge E., Dennis M., Forbes J., Hand P., Kwan J., Lewis S., Lindley R., Neilson A., Thomas B., Wardlaw J., A systematic review of the effectiveness, cost-effectiveness and barriers to implementation of thrombolytic and neuroprotective therapy for acute ischaemic stroke in the NHS, 10.3310/hta6260
  24. Intercollegiate Working Party for Stroke: National Clinical Guidelines for Stroke Update 2002. 2002, London, Royal College of Physicians
  25. Langhorne P., What are the components of effective stroke unit care?, 10.1093/ageing/31.5.365
  26. Leonardi-Bee J., Bath P. M.W., Phillips S. J., Sandercock P. A.G., Blood Pressure and Clinical Outcomes in the International Stroke Trial, 10.1161/01.str.0000014509.11540.66
  27. Tanne D., Markers of Increased Risk of Intracerebral Hemorrhage After Intravenous Recombinant Tissue Plasminogen Activator Therapy for Acute Ischemic Stroke in Clinical Practice: The Multicenter rt-PA Acute Stroke Survey, 10.1161/01.cir.0000012747.53592.6a
  28. Ciccone Alfonso, Consent to thrombolysis in acute ischaemic stroke: from trial to practice, 10.1016/s1474-4422(03)00412-5
  29. Koops L., Thrombolysis for acute ischaemic stroke: consumer involvement in design of new randomised controlled trial, 10.1136/bmj.325.7361.415
  30. Taves Donald R., Minimization: A new method of assigning patients to treatment and control groups, 10.1002/cpt1974155443
  31. Counsell C., Dennis M., McDowall M., Warlow C., Predicting Outcome After Acute and Subacute Stroke: Development and Validation of New Prognostic Models, 10.1161/hs0402.105909
  32. Brott T., Lu M., Kothari R., Fagan S. C., Frankel M., Grotta J. C., Broderick J., Kwiatkowski T., Lewandowski C., Haley E. C., Marler J. R., Tilley B. C., Hypertension and Its Treatment in the NINDS rt-PA Stroke Trial, 10.1161/01.str.29.8.1504
  33. Blood pressure in Acute Stroke Collaboration: Vasoactive drugs for acute stroke. Cochrane Library. 2003, Oxford: Update Software, 2
  34. International Society of Hypertension (ISH) : Statement on the Management of Blood Pressure in Acute Stroke, 10.1097/00004872-200304000-00003
  35. Ludlam C. A., Bennett B., Fox K. A. A., Lowe G. D. O., Reid A. W., Guidelines for the use of thrombolytic therapy : , 10.1097/00001721-199505000-00012
  36. Clauss A., Gerinnungsphysiologische Schnellmethode zur Bestimmung des Fibrinogens, 10.1159/000205234
  37. Hill MD, Barber PA, Takahashi J, Demchuk AM, Feasby TE, Buchan AM: Anaphylactoid reactions and angioedema during alteplase treatment of acute stroke. CMAJ. 2000, 162: 1281-1284.
  38. , Randomised controlled trial of streptokinase, aspirin, and combination of both in treatment of acute ischaemic stroke, 10.1016/s0140-6736(95)92049-8
  39. Collaboration A. T., Collaborative meta-analysis of randomised trials of antiplatelet therapy for prevention of death, myocardial infarction, and stroke in high risk patients, 10.1136/bmj.324.7329.71
  40. Bamford J. M., Sandercock P. A., Warlow C. P., Slattery J., Interobserver agreement for the assessment of handicap in stroke patients, 10.1161/01.str.20.6.828
  41. Lindley Richard I., Waddell Fiona, Livingstone Marion, Sandercock Peter, Dennis Martin S., Slattery Jim, Smith Brenda, Warlow Charles, Can Simple Questions Assess Outcome after Stroke?, 10.1159/000108501
  42. Dorman P., Are the modified "simple questions" a valid and reliable measure of health related quality of life after stroke?, 10.1136/jnnp.69.4.487
  43. Dorman P J, Slattery J, Farrell B, Dennis M S, Sandercock P A G, A randomised comparison of the EuroQol and Short Form-36 after stroke, 10.1136/bmj.315.7106.461
  44. Bamford J., Sandercock P., Dennis M., Warlow C., Burn J., Classification and natural history of clinically identifiable subtypes of cerebral infarction, 10.1016/0140-6736(91)93206-o
  45. Peto R, Pike M C, Armitage P, Breslow N E, Cox D R, Howard S V, Mantel N, McPherson K, Peto J, Smith P G, Design and analysis of randomized clinical trials requiring prolonged observation of each patient. II. Analysis and examples, 10.1038/bjc.1977.1
  46. MRC Clinical Trials Series: MRC Guidelines for Good Clinical Practice in Clinical Trials. 1998, London: Medical Research Council
  47. The Safe Implementation of Thrombolysis in Stroke (SITS) website. accessed on 27 May 2003, http://www.acutestroke.org
  48. The Third International Stroke Trial (IST-3) website. http://www.ist3.com
Bibliographic reference Sandercock, Peter ; Lindley, Richard ; Wardlaw, Joanna ; Dennis, Martin ; Lewis, Steff ; et. al. The third international stroke trial (IST-3) of thrombolysis for acute ischaemic stroke. In: Trials, Vol. 9, no. 17, p. [1-17] (2008)
Permanent URL http://hdl.handle.net/2078.1/36473