Treatment with exenatide in acute ischemic stroke trial protocol: A prospective, randomized, open label, blinded end-point study of exenatide vs. standard care in post stroke hyperglycemia

International Journal of Stroke

Volumn 13, Issue 8, 2018, Pages 857-862

  Muller, Claire ^a,b   Cheung, N Wah ^c   Dewey, Helen ^a   Churilov, Leonid ^d   Middleton, Sandy ^e   Thijs, Vincent ^d   Ekinci, Elif I ^f   Levi, Chris ^g,h   Lindley, Richard ^i,j   Donnan, Geoffrey ^d   Parsons, Mark ^g,h   Bladin, Christopher ^a,d  

^a MONASH UNIVERSITY   (Australia)

^b ROYAL BRISBANE AND WOMEN'S HOSPITAL   (Australia)

^c UNIVERSITY OF SYDNEY   (Australia)

^d FLOREY INSTITUTE OF NEUROSCIENCE AND MENTAL HEALTH   (Australia)

^e AUSTRALIAN CATHOLIC UNIVERSITY   (Australia)

^f UNIVERSITY OF MELBOURNE   (Australia)

^g UNIVERSITY OF NEWCASTLE   (Australia)

^h JOHN HUNTER HOSPITAL   (Australia)

ⁱ UNIVERSITY OF SYDNEY   (Australia)

^j GEORGE INSTITUTE FOR GLOBAL HEALTH   (Australia)

more..

Author keywords

Acute stroke therapy; exenatide; glucagon like peptide 1 analog; hyperglycemia; incretin; ischemic stroke; neuroprotection

Indexed keywords

BIOLOGICAL MARKER; EXENDIN 4; GELATINASE B; GLUCOSE; INTERLEUKIN 1BETA; INTERLEUKIN 6; TUMOR NECROSIS FACTOR; ANTIDIABETIC AGENT;

ADULT; ARTICLE; BLOOD GLUCOSE MONITORING; BRAIN FUNCTION; BRAIN ISCHEMIA; CLINICAL PROTOCOL; COMPARATIVE EFFECTIVENESS; CONTROLLED STUDY; DISEASE DURATION; DISEASE SEVERITY; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; DYNAMICS; HEALTH CARE QUALITY; HUMAN; HYPERGLYCEMIA; HYPOGLYCEMIA; IMMUNOPATHOGENESIS; MAJOR CLINICAL STUDY; MULTICENTER STUDY; NATIONAL INSTITUTES OF HEALTH STROKE SCALE; OPEN STUDY; PHASE 2 CLINICAL TRIAL; POST STROKE HYPERGLYCEMIA; PRIORITY JOURNAL; PROSPECTIVE STUDY; RANDOMIZED CONTROLLED TRIAL; TREATMENT OUTCOME; ADOLESCENT; AGED; CEREBROVASCULAR ACCIDENT; FEMALE; MALE; MIDDLE AGED; YOUNG ADULT;

ADOLESCENT; ADULT; AGED; BRAIN ISCHEMIA; EXENATIDE; FEMALE; HUMANS; HYPERGLYCEMIA; HYPOGLYCEMIC AGENTS; MALE; MIDDLE AGED; PROSPECTIVE STUDIES; STROKE; TREATMENT OUTCOME; YOUNG ADULT;

EID: 85050275396     PISSN: 17474930     EISSN: 17474949     Source Type: Journal    
DOI: 10.1177/1747493018784436     Document Type: Article

References (27)

1. Capes SE, Hunt D, Malmberg K, Pathak P, Gerstein HC. Stress hyperglycemia and prognosis of stroke in nondiabetic and diabetic patients: a systematic overview. Stroke 2001; 32: 2426–2432
2. Allport L, Baird T, Butcher K, Frequency and temporal profile of poststroke hyperglycemia using continuous glucose monitoring. Diab Care 2006; 29: 1839–1844
3. Muir KW, McCormick M, Baird T, Ali M. Prevalence, predictors and prognosis of post-stroke hyperglycaemia in acute stroke trials: individual patient data pooled analysis from the Virtual International Stroke Trials Archive (VISTA). Cerebrovasc Dis Extra 2011; 1: 17–27
4. Dziedzic T, Pera J, Trabka-Janik E, Szczudlik A. The impact of postadmission glycemia on stroke outcome: glucose normalisation is associated with better survival. Atherosclerosis 2010; 211: 584–588
5. Kruyt ND, Biessels G, DeVries HJ, Roos YB. Hyperglycemia in acute ischemic stroke: pathophysiology and clinical management. Nat Rev Neurol 2010; 6: 145–155
6. Baird T, Parsons M, Phanh T, Persistent post stroke hyperglycemia is indepentently associated with infarct expansion and worse clinical outcome. Stroke 2003; 34: 2208–2214
7. Drury P, Levi C, D'Este C, Quality in acute stroke care (QASC): process evaluation of an intervention to improve the management of fever, hyperglycemia, and swallowing dysfunction following acute stroke. Int J Stroke 2014; 9: 766–776
8. Investigators TN-SS. Hypoglycemia and risk of death in critically ill patients. N Eng J Med 2012; 367: 1108–1118
9. Gray CS, Hildreth AJ, Sandercock PA, O'Connell JE. Glucose-potassium-insulin infusions in the management of post-stroke hyperglycaemia: the UK Glucose Insulin in Stroke Trial (GIST-UK). Lancet Neurol 2007; 6: 397–406
10. McCormick M, Hadley D, McLean JR, Macfarlane JA, Condon B, Muir KW. Randomized, controlled trial of insulin for acute poststroke hyperglycemia. Ann Neurol 2010; 67: 570–578
11. Rosso C, Corvol JC, Pires C, Crozier S, Attal Y. Intensive versus subcutaneous insulin in patients with hyperacute stroke results from the randomized INSULINFARCT trial. Stroke 2012; 43: 2343–2349
12. Ginsberg MD. Hyperglycemia and stroke outcome: vindication of the ischemic penumbra. Ann Neurol 2002; 52: 5–6
13. Parsons MW, Barber AP, Desmond PM, Acute hyperglycemia adversely affects stroke outcome: a magnetic resonance imaging and spectroscopy study. Ann Neurol 2002; 52: 20–28
14. Kawai N, Keep RF, Betz AL, Nagao S. Hyperglycemia induces progressive changes in the cerebral microvasculature and blood-brain barrier transport during focal cerebral ischemia. Acta Neurochir Suppl 1998; 71: 219–221
15. Pandolfi A, Giaccari A, Cilli C, Acute hyperglycemia and acute hyperinsulinemia decrease plasma fibrinolytic activity and increase plasminogen activator inhibitor type 1 in the rat. Acta Diabetol 2001; 38: 71–76
16. Demchuk AM, Morgenstern LB, Krieger DW, Serum glucose level and diabetes predict tissue plasminogen activator-related intracerebral hemorrhage in acute ischemic stroke. Stroke 1999; 30: 34–39
17. Kamada H, Yu F, Nito C, Chan PH. Influence of hyperglycemia on oxidative stress and matrix metalloproteinase-9 activation after focal cerebral ischemia/reperfusion in rats: relation to blood-brain barrier dysfunction. Stroke 2007; 38: 1044–1049
18. Ribo M, Molina CA, Delgado P, Hyperglycemia during Ischemia rapidly accelerates brain damage in stroke patients treated with tPA. J Cereb Blood Flow Metab 2007; 27: 1616–1622
19. Kimura R, Okouchi M, Fujioka H, Glucagon-like peptide-1 (GLP-1) protects against methylglyoxal-induced PC12 cell apoptosis through the PI3K/Akt/mTOR/GCLc/redox signaling pathway. Neuroscience 2009; 162: 1212–1219
20. Li Y, Perry T, Kindy MS, GLP-1 receptor stimulation preserves primary cortical and dopaminergic neurons in cellular and rodent models of stroke and Parkinsonism. Proc Natl Acad Sci U S A 2009; 106: 1285–1290
21. Lonborg J, Kelbaek H, Vejlstrup N, Exenatide reduces final infarct size in patients with ST-segment-elevation myocardial infarction and short-duration of ischemia. Circul Cardiovasc Intervent 2012; 5: 288–295
22. Daly SC, Chemmanam T, Loh PS, Exenatide in acute ischemic stroke. Int J Stroke 2013; 8: E44
23. Association A. (2) Classification and diagnosis of diabetes. Diabetes Care 2015; January(38 Suppl): S8–S16
24. Kerr DM, Fulton RL, Lees KR, collaborators V. Seven-day NIHSS is a sensitive outcome measure for exploratory clinical trials in acute stroke evidence from the virtual international stroke trials archive. Stroke 2012; 43: 1401–1403
25. Sachedina N, Pickup JC. Performance assessment of the Medtronic-MiniMed Continuous Glucose Monitoring System and its use for measurement of glycaemic control in Type 1 diabetic subjects. Diab Med 2003; 20: 1012–1015
26. Saver JL, Altman H. Relationship between neurologic deficit severity and final functional outcome shifts and strengthens during first hours after onset. Stroke 2012; 43: 1537–1541
27. Mehta CR, Pocock SJ. Adaptive increase in sample size when interim results are promising: a practical guide with examples. Stat Med 2011; 30: 3267–3284