Targeting neuroprotection clinical trials to ischemic stroke patients with potential to benefit from therapy

Stroke

Volumn 35, Issue 9, 2004, Pages 2111-2116

  Weir, Christopher J ^a   Kaste, Markku ^b   Lees, Kennedy R ^a  

^a UNIVERSITY OF GLASGOW   (United Kingdom)

^b HELSINKI UNIVERSITY CENTRAL HOSPITAL   (Finland)

Author keywords

Clinical trials; Neuroprotection; Prognosis

Indexed keywords

ALTEPLASE; GLYCINE RECEPTOR ANTAGONIST; PLACEBO;

ARTICLE; BARTHEL INDEX; CEREBROVASCULAR ACCIDENT; CLINICAL TRIAL; GLASGOW OUTCOME SCALE; HUMAN; MEASUREMENT; MODEL; NATIONAL INSTITUTES OF HEALTH STROKE SCALE; NEUROPROTECTION; OUTCOMES RESEARCH; PATIENT SELECTION; PRIORITY JOURNAL; PROGNOSIS; RANKIN SCALE; SAMPLE SIZE; SIMULATION; STATISTICAL POWER; STATISTICAL SIGNIFICANCE; VALIDATION PROCESS;

AGED; AGED, 80 AND OVER; BIOLOGICAL MARKERS; BRAIN ISCHEMIA; ENDPOINT DETERMINATION; FEMALE; GLASGOW OUTCOME SCALE; HUMANS; MALE; MIDDLE AGED; MODELS, THEORETICAL; NEUROPROTECTIVE AGENTS; PATIENT SELECTION; PROGNOSIS; RANDOMIZED CONTROLLED TRIALS; RECOMBINANT PROTEINS; SAMPLE SIZE; SEVERITY OF ILLNESS INDEX; THROMBOLYTIC THERAPY; TISSUE PLASMINOGEN ACTIVATOR; TREATMENT OUTCOME;

EID: 4344681458     PISSN: 00392499     EISSN: None     Source Type: Journal    
DOI: 10.1161/01.STR.0000136556.34438.b3     Document Type: Article

References (25)

1. Kidwell CS, Liebeskind DS, Starkman S, Saver JL. Trends in acute ischemic stroke trials through the 20th century. Stroke. 2001;32: 1349-1359.
2. Stroke Therapy Academic Industry Roundtable II (STAIR-II). Recommendations for clinical trial evaluation of acute stroke therapies. Stroke. 2001;32:1598-1606.
3. Muir KW. Heterogeneity of stroke pathophysiology and neuroprotective clinical trial design. Stroke. 2002;33:1545-1550.
4. Dorman PJ, Sandercock PA. Considerations in the design of clinical trials of neuroprotective therapy in acute stroke. Stroke. 1996;27:1507-1515.
5. Wahlgren NG, Ranasinha KW, Rosolacci T, Franke CL, van Erven PM, Ashwood T, Claesson L. Clomethiazole Acute Stroke Study (CLASS): results of a randomized, controlled trial of clomethiazole versus placebo in 1360 acute stroke patients. Stroke. 1999;30:21-28.
6. Clark WM, Wechsler LR, Sabounjian LA, Schwiderski UE, for the Citicoline Stroke Study Group. A phase III randomized efficacy trial of 2000 mg citicoline in acute ischemic stroke patients. Neurology. 2001; 57:1595-1602.
7. The Multicenter Acute Stroke Trial-Europe Study Group. Thrombolytic therapy with streptokinase in acute ischemic stroke. N Engl J Med. 1996;335:145-150.
8. Hacke W, Kaste M, Fieschi C, Toni D, Lesaffre E, von Kummer R, Boysen G, Bluhmki E, Hoxter G, Mahagne MH, et al. Intravenous thrombolysis with recombinant tissue plasminogen activator for acute hemispheric stroke. The European Cooperative Acute Study (ECASS) JAMA. 1995;274:1017-1025.
9. Donnan GA, Davis SM, Chambers BR, Gates PC, Hankey GJ, McNeil JJ, Rosen D, Stewart-Wynne EG, Tuck RR, for the Australian Streptokinase (ASK) Trial Study Group. Streptokinase for acute ischemic stroke with relationship to time of administration. JAMA. 1996;276:961-966.
10. Enlimomab Acute Stroke Trial Investigators. Use of anti-ICAM-1 therapy in ischemic stroke: results of the Enlimomab Acute Stroke Trial. Neurology. 2001;57:1428-1433.
11. Lyden P, Shuaib A, Ng K, Levin K, Atkinson RP, Rajput A, Wechsler L, Ashwood T, Claesson L, Odergren T, Salazar-Grueso E. Clomethiazole Acute Stroke Study in Ischemic Stroke (CLASS-I): final results. Stroke. 2002;33:122-128.
12. Davis SM, Lees KR, Albers GW, Diener HC, Markabi S, Karlsson G, Norris J. Selfotel in acute ischemic stroke: possible neurotoxic effects of an NMDA antagonist. Stroke. 2000;31:347-354.
13. Machado SG, Murray GD, Teasdale GM. Evaluation of designs for clinical trials of neuroprotective agents in head injury. J Neurotrauma. 1999;16:1131-1138.
14. Lees KR, Asplund K, Carolei A, Davis SM, Diener HC, Kaste M, Orgogozo JM, Whitehead J. Glycine Antagonist (gavestinel) in Neuroprotection (GAIN International) in patients with acute stroke: a randomised controlled trial. Lancet. 2000;355:1949-1954.
15. The National Institute of Neurological Disorders and Stroke rt-PA Stroke Study Group. Tissue plasminogen activator for acute ischemic stroke. N Engl J Med. 1995;333:1581-1587.
16. Counsell C, Dennis M. Systematic review of prognostic models in patients with acute stroke. Cerebrovasc Dis. 2001;12:159-170.
17. Tilley BC, Marler JR, Geller NL, Lu M, Legler JM, Brott TG, Lyden PD, Grotta J. Use of a global test for multiple outcomes in stroke trials with application to the National Institute of Neurological Disorders and Stroke t-PA Stroke Trial. Stroke. 1996;27:2136-2142.
18. Brott TG, Adams HP, Olinger CP, Marler JR, Barsan WG, Biller J, Spilker J, Holleran R, Eberle R, Hertzberg V, Rorick M, Moomaw CJ, Walker M. Measurements of acute cerebral infarction: a clinical examination scale. Stroke. 1989;20:864-870.
19. Efron B, Tibshirani RJ. An Introduction to the Bootstrap. New York, NY: Chapman and Hall; 1993.
20. Park CG, Park T, Shin DW. A simple method for generating correlated binary variates. Am Stat. 1996;50:306-310.
21. Machin D, Campbell MJ. Statistical Tables for the Design of Clinical Trials. Oxford, UK: Blackwell Scientific Publications; 1987.
22. Tariot PN, Federoff HJ. Current treatment for Alzheimer disease and future prospects. Alzheimer Dis Assoc Disord. 2003;17:S105-S113.
23. De Keyser J, Sulter G, Luiten PG. Clinical trials with neuroprotective drugs in acute ischaemic stroke: are we doing the right thing? Trends Neurosci. 1999;22:535-540.
24. Schlaug G, Benfield A, Baird AE, Siewert B, Lovblad KO, Parker RA, Edelman RR, Warach S. The ischemic penumbra: operationally defined by diffusion and perfusion MRI. Neurology. 1999;53:1528-1537.
25. Wardlaw JM, del Zoppo G, Yamaguchi T. Thrombolysis for acute ischemic stroke (Cochrane review). In: The Cochrane Library, Issue 1, 2002. Oxford, UK: Update Software.