Randomised trial of clazosentan, an endothelin receptor antagonist, in patients with aneurysmal subarachnoid hemorrhage undergoing surgical clipping (CONSCIOUS-2)

Macdonald, R. Loch; Higashida, Randall T.; Keller, Emanuela; Mayer, Stephan A.; Molyneux, Andy; Raabe, Andreas; Vajkoczy, Peter; Wanke, Isabel; Bach, Doris; Frey, Aline; Marr, Angelina; Roux, Sébastien; Kassell, Neal (2013). Randomised trial of clazosentan, an endothelin receptor antagonist, in patients with aneurysmal subarachnoid hemorrhage undergoing surgical clipping (CONSCIOUS-2). Acta neurochirurgica - supplementa, 115, pp. 27-31. Springer 10.1007/978-3-7091-1192-5_7

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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.

Item Type:

Journal Article (Original Article)

Division/Institute:

04 Faculty of Medicine > Department of Head Organs and Neurology (DKNS) > Clinic of Neurosurgery

UniBE Contributor:

Raabe, Andreas

Subjects:

600 Technology > 610 Medicine & health

ISSN:

0065-1419

Publisher:

Springer

Language:

English

Submitter:

Nicole Söll

Date Deposited:

04 Apr 2014 08:21

Last Modified:

04 Apr 2014 08:21

Publisher DOI:

10.1007/978-3-7091-1192-5_7

PubMed ID:

22890639

URI:

https://boris.unibe.ch/id/eprint/44676

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