Clazosentan in Aneurysmal Subarachnoid Hemorrhage

Phase 3

Terminated

Interventions: Drug: Placebo
Drug: Clazosentan 5 m/h
Drug: Clazosentan 15 mg/h

Brief Summary: 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.

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Continuous intravenous infusion of placebo matching clazosentan started within 56 hours post-aSAH and scheduled to continue until Day 14 post-aSAH, or at least until Day 10 post-aSAH, for patients discharged before Day 14
Clazosentan 5 mg/h	Clazosentan 5 m/h	Continuous intravenous infusion of clazosentan (5 mg/h) started within 56 hours post-aSAH and scheduled to continue until Day 14 post-aSAH, or at least until Day 10 post-aSAH, for patients discharged before Day 14
Clazosentan 15 mg/h	Clazosentan 15 mg/h	Continuous intravenous infusion of clazosentan (15 mg/h) started within 56 hours post-aSAH and scheduled to continue until Day 14 post-aSAH, or at least until Day 10 post-aSAH, for patients discharged before Day 14

Primary Outcome Measures

Name	Time	Method
Cerebral vasospasm-related morbidity and mortality of all-causes as defined by the protocol	Within 6 weeks post-aSAH

Secondary Outcome Measures

Name	Time	Method
Glasgow Outcome Scale Extended (GOSE) at Week 12 post-aSAH, dichotomized into good (score > 4) and poor (score ≤ 4) outcome.	Week 12 post-aSAH

Locations (144): Glendale Adventist Medical Center
🇺🇸
Glendale, California, United States
UCSF Medical Centre
🇺🇸
San Francisco, California, United States
Stanford Hospital and Clinis
🇺🇸
Stanford, California, United States
Colorado Neurological Institute
🇺🇸
Englewood, Colorado, United States
Yale Univerity School of Medicine
🇺🇸
New Haven, Connecticut, United States
University of South Florida
🇺🇸
Tampa, Florida, United States
Rush University Medical Center
🇺🇸
Chicago, Illinois, United States
University of Illnois
🇺🇸
Chicago, Illinois, United States
Massachusetts General Hospital
🇺🇸
Boston, Massachusetts, United States
Boston Medical Centre
🇺🇸
Boston, Massachusetts, United States
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Glendale Adventist Medical Center
🇺🇸Glendale, California, United States