Subarachnoid Hemorrhage: Clazosentan vs. Fasudil for Vasospasm Prevention (SAVIOR) Study: Study Protocol for a...

Area of Science:

• Neurology
• Clinical Trials
• Pharmacology

Background:

• Aneurysmal subarachnoid hemorrhage (aSAH) frequently leads to poor neurological outcomes due to cerebral vasospasm.
• Fasudil is the standard prophylactic treatment in Japan, but its long-term functional outcome benefits are unclear.
• Clazosentan, an endothelin-A receptor antagonist, shows promise in reducing vasospasm-related morbidity.

Purpose of the Study:

• To determine the superiority of clazosentan over fasudil in improving functional independence in aSAH patients in Japan.
• To provide the first direct comparative data on clazosentan and fasudil efficacy and safety in a nimodipine-free population.

Main Methods:

• A multicenter, randomized, open-label, parallel-group superiority trial (SAVIOR study).
• 21 high-volume stroke centers in Japan.
• Patients with aSAH randomized 1:1 to intravenous clazosentan or fasudil within 48 hours of onset.

Main Results:

• Primary outcome: Proportion of patients with favorable functional outcome (modified Rankin Scale 0-2 at 90 days).
• Secondary outcomes: mRS at discharge, incidence of cerebral vasospasm, delayed cerebral ischemia, and safety profiles (including fluid retention).

Conclusions:

• This trial is the first to directly compare clazosentan and fasudil in a Japanese aSAH population.
• The study aims to generate pragmatic evidence to inform clinical decision-making and potentially update treatment guidelines in Japan.
• Results will address a critical clinical question not covered by prior international trials.