Ignite Creation Date:
2024-05-05 @ 6:52 PM
Last Modification Date:
2024-10-26 @ 9:37 AM
Study NCT ID:
NCT00558311
Status:
COMPLETED
Last Update Posted:
2020-02-17
First Post:
2007-11-13
Brief Title:
Clazosentan in Reducing Vasospasm-related Morbidity and All-cause Mortality in Adult Patients With Aneurysmal Subarachnoid Hemorrhage Treated by Surgical Clipping
Sponsor:
Idorsia Pharmaceuticals Ltd
Organization:
Idorsia Pharmaceuticals Ltd
Study Overview
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 Surgical Clipping
Status:
COMPLETED
Status Verified Date:
2020-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CONSCIOUS-2
Brief Summary:
The aim of this study is to demonstrate that clazosentan administered as a continuous intravenous infusion at 5 mgh 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 surgical clipping 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 infarcts 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 Neurological signs or symptoms depending on state of consciousness in the presence of confirmed cerebral vasospasm on angiography DSA or CTA leading to the administration of a valid rescue therapy
An independent Critical Events Committee CEC will adjudicate whether or not patients meet the primary endpoint and its individual morbidity components
1 Death all causes
2 New cerebral infarcts 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 Neurological signs or symptoms depending on state of consciousness in the presence of confirmed cerebral vasospasm on angiography DSA or CTA leading to the administration of a valid rescue therapy
An independent Critical Events Committee CEC will adjudicate whether or not patients meet the primary endpoint and its individual morbidity components
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None