Document Detail


Randomised Trial of Clazosentan, an Endothelin Receptor Antagonist, in Patients with Aneurysmal Subarachnoid Hemorrhage Undergoing Surgical Clipping (CONSCIOUS-2).
MedLine Citation:
PMID:  22890639     Owner:  NLM     Status:  In-Data-Review    
Abstract/OtherAbstract:
We report here results of a randomized, double-blind, placebo-controlled study ( http://www.ClinicalTrials.gov , NCT00558311) that investigated the effect of clazosentan (5 mg/h, n = 768) or placebo (n = 389) administered for up to 14 days in patients with aneurysmal subarachnoid hemorrhage (SAH) repaired by surgical clipping. The primary endpoint was a composite of all-cause mortality, new cerebral infarction or delayed ischemic neurological deficit due to vasospasm, and rescue therapy for vasospasm. The main secondary endpoint was the Glasgow Outcome Scale Extended (GOSE), which was dichotomized. Twenty-one percent of clazosentan- compared to 25% of placebo-treated patients met the primary endpoint (relative risk reduction [RRR] [95% CI]: 17% [-4% to 33%]; p = 0.10). Poor outcome (GOSE score ≤ 4) occurred in 29% of clazosentan- and 25% of placebo-treated patients (RRR: -18% [-45% to 4%]; p = 0.10). In prespecified subgroups, mortality/vasospasm-related morbidity was reduced in clazosentan-treated patients by 33% (8-51%) in poor WFNS (World Federation of Neurological Surgeons) grade (≥III) and 25% (5-41%) in patients with diffuse, thick SAH. Lung complications, anemia and hypotension occurred more frequently with clazosentan. Mortality (week 12) was 6% in both groups. The results showed that clazosentan nonsignificantly decreased mortality/vasospasm-related morbidity and nonsignificantly increased poor functional outcome in patients with aneurysmal SAH undergoing surgical clipping.
Authors:
R Loch Macdonald; Randall T Higashida; Emanuela Keller; Stephan A Mayer; Andy Molyneux; Andreas Raabe; Peter Vajkoczy; Isabel Wanke; Doris Bach; Aline Frey; Angelina Marr; Sébastien Roux; Neal Kassell
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Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Acta neurochirurgica. Supplement     Volume:  115     ISSN:  0065-1419     ISO Abbreviation:  Acta Neurochir. Suppl.     Publication Date:  2013  
Date Detail:
Created Date:  2012-08-14     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  100962752     Medline TA:  Acta Neurochir Suppl     Country:  Austria    
Other Details:
Languages:  eng     Pagination:  27-31     Citation Subset:  IM    
Affiliation:
Division of Neurosurgery, Labatt Family Centre of Excellence in Brain Injury and Trauma Research, Keenan Research Centre, Li Ka Shing Knowledge Institute, St. Michael's Hospital, 30 Bond Street, Toronto, M5B 1W8, ON, Canada, macdonaldlo@smh.ca.
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