The aim of this study is to demonstrate that clazosentan, administered as a continuous
intravenous infusion at either 5 mg/h or 15 mg/h until Day 14 post aneurysmal subarachnoid
hemorrhage (aSAH), reduces the incidence of cerebral vasospasm-related morbidity and
all-cause mortality within 6 weeks post-aSAH treated by endovascular coiling.
The primary endpoint of the study is the occurrence of cerebral vasospasm-related morbidity,
and mortality of all-causes within 6 weeks post-aSAH, defined by at least one of the
following:
1. Death (all causes).
2. New cerebral infarct(s) due to cerebral vasospasm as either the primary or relevant
contributing cause, or not adjudicated to be entirely due to causes other than
vasospasm.
3. Delayed ischemic neurological deficit (DIND) due to cerebral vasospasm as either the
primary or relevant contributing cause, or not adjudicated to be entirely due to causes
other than vasospasm.
4. Administration of a valid rescue therapy in the presence of confirmed cerebral vasospasm
on angiography (DSA or CTA).
An independent Critical Events Committee (CEC) will adjudicate whether or not patients meet
the primary endpoint and its individual morbidity components.