Reduction of vasospasm in a dose-dependent fashion from 66% in the placebo group to 23% in the 15 mg/h clazosentan group (risk reduction, 65%; 95% CI, 47% to 78%; ) Clazosentan was associated with pulmonary complications, hypotension, and anemia
Clazosentan group (5 mg/h, patients) and placebo group ( patients)
The primary endpoint was met in 161 patients (21%) of the clazosentan group and in 97 patients (25%) of the placebo group. Relative risk reduction 17%, (95% CI −4 to 33; ). Poor functional outcome (GOSE score ≤ 4) occurred in 224 (29%) in the clazosentan group and in 95 patients (25%) in the placebo group. Mortality was 6% in both groups. Clazosentan was associated with lung complications, anaemia, and hypotension
CONSCIOUS-3 was halted prematurely following the completion of the CONSCIOUS-2. A total of 577/1500 of planned patients were enrolled, and 571 were treated (placebo, patients; clazosentan 5 mg/h, patients; clazosentan 15 mg/h, patients).
The primary endpoint was reached in 50/189 of placebo-treated patients (27%), compared with 47/194 patients (24%) treated with clazosentan 5 mg/h and 28/188 patients (15%) treated with clazosentan 15 mg/h. Poor outcome (extended Glasgow Outcome Scale score ≤ 4) occurred in 24% of patients in the placebo group, 25% of patients with clazosentan 5 mg/h, and 28% of patients with clazosentan 15 mg/h. Mortality was 6%, 4%, and 6% with placebo, clazosentan 5 mg/h, and clazosentan 15 mg/h, respectively. Clazosentan-associated complications were pulmonary complications, anemia, and hypotension
