Clazosentan in Aneurysmal Subarachnoid Hemorrhage (CONSCIOUS-3)
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|ClinicalTrials.gov Identifier: NCT00940095|
Recruitment Status : Terminated (Lack of efficacy data from the Phase 3 clinical study (AC-054-301; CONSCIOUS-2))
First Posted : July 15, 2009
Last Update Posted : May 15, 2015
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:
- Death (all causes).
- 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.
- 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.
- 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.
|Condition or disease||Intervention/treatment||Phase|
|Aneurysmal Subarachnoid Hemorrhage||Drug: Clazosentan Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||577 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Prospective, Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Assess the Efficacy and Safety of Clazosentan in Reducing Vasospasm-related Morbidity and All-cause Mortality in Adult Patients With Aneurysmal Subarachnoid Hemorrhage Treated by Endovascular Coiling.|
|Study Start Date :||July 2009|
|Primary Completion Date :||October 2010|
|Study Completion Date :||January 2011|
|Experimental: Clazosentan, 5mg/h||
Other Name: AXV-034343
|Experimental: Clazosentan 15mg/h||
Other Name: AXV-034343
|Placebo Comparator: Placebo||
- Cerebral vasospasm-related morbidity and mortality of all-causes as defined by the protocol [ Time Frame: Within 6 weeks post-aSAH ]
- Glasgow Outcome Scale Extended (GOSE) at Week 12 post-aSAH, dichotomized into good (score > 4) and poor (score ≤ 4) outcome. [ Time Frame: Week 12 post-aSAH ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00940095
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|Study Director:||Sebastien Roux, MD||Actelion|