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Brief description/objective

Aneurysmal subarachnoid hemorrhage has been designated as an orphan disease and remains an important cause of morbidity and mortality despite advances in medical and surgical therapy. One important complication of subarachnoid hemorrhage is cerebral vasospasm, which may cause cerebral ischemia and infarction and consequently significant morbidity and mortality. Although cerebral vasospasm may be responsible for poor neurological outcome after subarachnoid hemorrhage only in a limited proportion of patients, the prevention of cerebral vasospasm remains a clinically important objective, as it is one of the few identified targets for pharmacological intervention in this patient population. The occurrence of vasospasm-related cerebral infarcts and DIND, both components of the proposed primary endpoint of the current study, has been shown in the Phase IIb study (post-hoc analysis) and in the literature, to be predictive of poor clinical outcome at 3 months post-aSAH. Cerebral vasospasm is currently treated with empirically derived and risky strategies such as hemodynamic therapy (vasopressors, fluids) and angioplasty. Thus, the availability of an anti-vasospastic drug with documented effect on the prevention of vasospasm-related ischemic events and with an acceptable safety profile would answer an unmet medical need in the care of patients with aSAH. The results of the current Phase III study will be used for the registration of clazosentan in the indication of prevention of cerebral vasospasm-related morbidity and all-cause mortality in aSAH patients treated by surgical clipping.