Randomised Trial of Clazosentan, an Endothelin Receptor Antagonist, in Patients with Aneurysmal Subarachnoid Hemorrhage Undergoing Surgical Clipping (CONSCIOUS-2)

摘要: We report here results of a randomized, double-blind, placebo-controlled study (http://www.ClinicalTrials.gov, NCT00558311) that investigated the effect 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 composite all-cause mortality, new cerebral infarction delayed ischemic neurological deficit due vasospasm, and rescue therapy vasospasm. main secondary Glasgow Outcome Scale Extended (GOSE), which dichotomized. Twenty-one percent clazosentan- compared 25% placebo-treated met (relative risk reduction [RRR] [95% CI]: 17% [−4% 33%]; p 0.10). Poor outcome (GOSE score ≤ 4) occurred 29% (RRR: −18% [−45% 4%]; In prespecified subgroups, mortality/vasospasm-related morbidity reduced clazosentan-treated 33% (8–51%) poor WFNS (World Federation Neurological Surgeons) grade (≥III) (5–41%) diffuse, thick SAH. Lung complications, anemia hypotension more frequently clazosentan. Mortality (week 12) 6% both groups. showed nonsignificantly decreased increased functional SAH undergoing