Safety and efficacy of NA-1 in patients with iatrogenic stroke after endovascular aneurysm repair (ENACT): A phase 2, randomised, double-blind, placebo-controlled trial

The Lancet Neurology

Volumn 11, Issue 11, 2012, Pages 942-950

  Hill, Michael D ^a   Martin, Renee H ^b   Mikulis, David ^c   Wong, John H ^a   Silver, Frank L ^c   terBrugge, Karel G ^c   Milot, Geneviève ^d   Clark, Wayne M ^e   MacDonald, R Loch ^f   Kelly, Michael E ^g   Boulton, Melford ^h   Fleetwood, Ian ⁱ   McDougall, Cameron ^j   Gunnarsson, Thorsteinn ^k   Chow, Michael ^l   Lum, Cheemun ^m   Dodd, Robert ⁿ   Poublanc, Julien ^c   Krings, Timo ^c   Demchuk, Andrew M ^a   Goyal, Mayank ^a   Anderson, Roberta ^o   Bishop, Julie ^o   Garman, David ^o   Tymianski, Michael ^c,f,o   more..

^a UNIVERSITY OF CALGARY   (Canada)

^b MEDICAL UNIVERSITY OF SOUTH CAROLINA   (United States)

^c UNIVERSITY OF TORONTO   (Canada)

^d UNIVERSITÉ LAVAL   (Canada)

^e OREGON HEALTH AND SCIENCE UNIVERSITY   (United States)

^f ST MICHAEL'S HOSPITAL   (Canada)

^g ROYAL UNIVERSITY HOSPITAL   (Canada)

^h UNIVERSITY OF WESTERN ONTARIO   (Canada)

ⁱ DALHOUSIE UNIVERSITY   (Canada)

^j BARROW NEUROLOGICAL INSTITUTE   (United States)

^k MCMASTER UNIVERSITY   (Canada)

^l UNIVERSITY OF ALBERTA HOSPITAL   (Canada)

^m UNIVERSITY OF OTTAWA   (Canada)

ⁿ STANFORD UNIVERSITY SCHOOL OF MEDICINE   (United States)

^o NoNO Inc   (Canada)

more..

Author keywords

[No Author keywords available]

Indexed keywords

NA 1; POSTSYNAPTIC DENSITY PROTEIN 95; SCAFFOLD PROTEIN; SODIUM CHLORIDE; UNCLASSIFIED DRUG;

ADULT; ARTICLE; CEREBROVASCULAR ACCIDENT; CONTROLLED STUDY; DIFFUSION WEIGHTED IMAGING; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; ENDOVASCULAR ANEURYSM REPAIR; FEMALE; HEADACHE; HUMAN; HYPERTENSION; HYPOTENSION; MAJOR CLINICAL STUDY; MALE; NAUSEA; NEUROPROTECTION; NUCLEAR MAGNETIC RESONANCE IMAGING; OUTCOME ASSESSMENT; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; TREATMENT OUTCOME; VOMITING;

ADULT; AGED; BRAIN ISCHEMIA; DOUBLE-BLIND METHOD; ENDOVASCULAR PROCEDURES; FEMALE; HUMANS; IATROGENIC DISEASE; INTRACRANIAL ANEURYSM; MALE; MIDDLE AGED; NEUROPROTECTIVE AGENTS; PEPTIDES; PLACEBOS; STROKE; TREATMENT OUTCOME;

EID: 84867641191     PISSN: 14744422     EISSN: 14744465     Source Type: Journal    
DOI: 10.1016/S1474-4422(12)70225-9     Document Type: Article

References (39)

1. The bitterest pill. Nature 2006, 444:532-533. Nature.
2. O'Collins VE, Macleod MR, Donnan GA, Horky LL, van der Worp BH, Howells DW 1026 experimental treatments in acute stroke. Ann Neurol 2006, 59:467-477.
3. Sacchetti ML Is it time to definitely abandon neuroprotection in acute ischemic stroke?. Stroke 2008, 39:1659-1660.
4. Tymianski M Can molecular and cellular neuroprotection be translated into therapies for patients? yes, but not the way we tried it before. Stroke 2010, 41:S87-S90.
5. Cook DJ, Teves L, Tymianski M Treatment of stroke with a PSD-95 inhibitor in the gyrencephalic primate brain. Nature 2012, 483:213-217.
6. Cook DJ, Teves L, Tymianski M. Re-enacting ENACT in gyrencephalic non-human primates: a translational paradigm for the preclinical evaluation of stroke neuroprotectants. Science Transl Med (in press).
7. Cronqvist M, Wirestam R, Ramgren B, et al. Diffusion and perfusion MRI in patients with ruptured and unruptured intracranial aneurysms treated by endovascular coiling: complications, procedural results, MR findings and clinical outcome. Neuroradiology 2005, 47:855-873.
8. Fisher M, Feuerstein G, Howells DW, et al. Update of the stroke therapy academic industry roundtable preclinical recommendations. Stroke 2009, 40:2244-2250.
9. Committee S Recommendations for standards regarding preclinical neuroprotective and restorative drug development. Stroke 1999, 30:2752-2758.
10. Kornau HC, Schenker LT, Kennedy MB, Seeburg PH Domain interaction between NMDA receptor subunits and the postsynaptic density protein PSD-95. Science 1995, 269:1737-1740.
11. Cui H, Hayashi A, Sun H, et al. PDZ protein interactions underlying NMDA-receptor-mediated excitotoxicity and neuroprotection by PSD-95 inhibitors. J Neuroscience 2007, 29:9901-9915.
12. Sattler R, Xiong Z, Lu WY, Hafner M, MacDonald JF, Tymianski M Specific coupling of NMDA receptor activation to nitric oxide neurotoxicity by PSD-95 protein. Science 1999, 284:1845-1848.
13. Aarts M, Liu Y, Liu L, et al. Treatment of ischemic brain damage by perturbing NMDA receptor-PSD-95 protein interactions. Science 2002, 298:846-850.
14. Sun HS, Doucette TA, Liu Y, et al. Effectiveness of PSD95 inhibitors in permanent and transient focal ischemia in the rat. Stroke 2008, 39:2544-2553.
15. Soriano FX, Martel MA, Papadia S, et al. Specific targeting of pro-death NMDA receptor signals with differing reliance on the NR2B PDZ ligand. J Neurosci 2008, 28:10696-10710.
16. Bratane BT, Cui H, Cook DJ, Bouley J, Tymianski M, Fisher M Neuroprotection by freezing ischemic penumbra evolution without cerebral blood flow augmentation with a postsynaptic density-95 protein inhibitor. Stroke 2011, 42:3265-3270.
17. Hachinski V, Iadecola C, Petersen RC, et al. National Institute of Neurological Disorders and Stroke-Canadian Stroke Network vascular cognitive impairment harmonization standards. Stroke 2006, 37:2220-2241.
18. Pocock SJ, Simon R Sequential treatment assignment with balancing for prognostic factors in the controlled clinical trial. Biometrics 1975, 31:103-115.
19. Brott T, Adams HP, Olinger CP, et al. Measurements of acute cerebral infarction: a clinical examination scale. Stroke 1989, 20:864-870.
20. van Swieten JC, Koudstaal PJ, Visser MC, Schouten HJ, van Gijn J Interobserver agreement for the assessment of handicap in stroke patients. Stroke 1988, 19:604-607.
21. Teasdale GM, Drake CG, Hunt W, et al. A universal subarachnoid hemorrhage scale: report of a committee of the World Federation of Neurosurgical Societies. J Neurol Neurosurg Psychiatry 1988, 51:1457.
22. Fisher CM, Kistler JP, Davis JM Relation of cerebral vasospasm to subarachnoid hemorrhage visualized by computerized tomographic scanning. Neurosurgery 1980, 6:1-9.
23. Lan KK, DeMets DL Changing frequency of interim analysis in sequential monitoring. Biometrics 1989, 45:1017-1020.
24. O'Brien PC, Fleming TR A multiple testing procedure for clinical trials. Biometrics 1979, 35:549-556.
25. Russell D Cerebral microemboli and cognitive impairment. J Neurol Sci 2002, 203-204:211-214.
26. Mocco J, Wilson DA, Komotar RJ, et al. Predictors of neurocognitive decline after carotid endarterectomy. Neurosurgery 2006, 58:844-850.
27. Schnaudigel S, Groschel K, Pilgram SM, Kastrup A New brain lesions after carotid stenting versus carotid endarterectomy: a systematic review of the literature. Stroke 2008, 39:1911-1919.
28. Cronqvist M, Wirestam R, Ramgren B, et al. Endovascular treatment of intracerebral arteriovenous malformations: procedural safety, complications, and results evaluated by MR imaging, including diffusion and perfusion imaging. AJNR Am J Neuroradiol 2006, 27:162-176.
29. Bonati LH, Jongen LM, Haller S, et al. New ischaemic brain lesions on MRI after stenting or endarterectomy for symptomatic carotid stenosis: a substudy of the International Carotid Stenting Study (ICSS). Lancet Neurol 2010, 9:353-362.
30. Gaita F, Caponi D, Pianelli M, et al. Radiofrequency catheter ablation of atrial fibrillation: a cause of silent thromboembolism? Magnetic resonance imaging assessment of cerebral thromboembolism in patients undergoing ablation of atrial fibrillation. Circulation 2010, 122:1667-1673.
31. Kahlert P, Knipp SC, Schlamann M, et al. Silent and apparent cerebral ischemia after percutaneous transfemoral aortic valve implantation: a diffusion-weighted magnetic resonance imaging study. Circulation 2010, 121:870-878.
32. Brott TG, Hobson RW, Howard G, et al. Stenting versus endarterectomy for treatment of carotid-artery stenosis. N Engl J Med 2010, 363:11-23.
33. Bonati LH, Dobson J, Algra A, et al. Short-term outcome after stenting versus endarterectomy for symptomatic carotid stenosis: a preplanned meta-analysis of individual patient data. Lancet 2010, 376:1062-1073.
34. Gorelick PB, Scuteri A, Black SE, et al. Vascular Contributions to Cognitive Impairment and Dementia: A Statement for Healthcare Professionals From the American Heart Association/American Stroke Association. Stroke 2011, 42:2672-2713.
35. Scott RB, Eccles F, Molyneux AJ, Kerr RS, Rothwell PM, Carpenter K Improved cognitive outcomes with endovascular coiling of ruptured intracranial aneurysms: neuropsychological outcomes from the International Subarachnoid Aneurysm Trial (ISAT). Stroke 2010, 41:1743-1747.
36. Muir KW, Lees KR Excitatory amino acid antagonists for acute stroke. Cochrane Database Syst Rev 2003, 3. CD001244.
37. Feng S, Yang Q, Liu M, et al. Edaravone for acute ischaemic stroke. Cochrane Database Syst Rev 2011, 12. CD007230.
38. Davalos A, Castillo J, Alvarez-Sabin J, et al. Oral citicoline in acute ischemic stroke: an individual patient data pooling analysis of clinical trials. Stroke 2002, 33:2850-2857.
39. Davalos A, Alvarez-Sabin J, Castillo J, et al. Citicoline in the treatment of acute ischaemic stroke: an international, randomised, multicentre, placebo-controlled study (ICTUS trial). Lancet 2012, 380:349-357.