Clazosentan in Preventing the Occurrence of Cerebral Vasospasm Following an Aneurysmal Subarachnoid Hemorrhage (aSAH)
- Conditions
- Aneurysmal Subarachnoid Hemorrhage
- Interventions
- Registration Number
- NCT00111085
- Lead Sponsor
- Idorsia Pharmaceuticals Ltd.
- Brief Summary
The purpose of the study is to measure how effective and safe three different doses of the drug clazosentan are in preventing vasospasm after subarachnoid hemorrhage.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 413
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Clazosentan 1 mg/h Clazosentan 1 mg/h intravenous clazosentan at 1 mg/h starting within 56 hours maximum after aneurysm rupture and continuing until Day 14 post-aneurysm rupture Clazosentan 15 mg/h Clazosentan 15 mg/h intravenous clazosentan at of 15 mg/h starting within 56 hours maximum after aneurysm rupture and continuing until Day 14 post-aneurysm rupture Clazosentan 5 mg/h Clazosentan 5 mg/h intravenous clazosentan at 5 mg/h starting within 56 hours maximum after aneurysm rupture and continuing until Day 14 post-aneurysm rupture Placebo Placebo intravenous placebo starting within 56 hours maximum after aneurysm rupture and continuing until Day 14 post-aneurysm rupture
- Primary Outcome Measures
Name Time Method Occurrence of moderate or severe cerebral vasospasm, as measured by cerebral angiography Up to day 14 If the patient develops clinical or sonographic changes suggestive of vasospasm prior to or after Day 9 ± 2 and until Day 14 post-aneurysm rupture, an angiogram will be performed to confirm the vasospasm. If vasospasm is documented prior to Day 9 ± 2, the Day 9 ± 2 angiogram is no longer required. In the case that a patient only develops clinical symptoms suggestive of vasospasm later than Day 9 ± 2 and up to Day 14, an additional angiogram should be performed to confirm the diagnosis of vasospasm. If the latter shows a higher grade of vasospasm than the previous one, it will be used for comparison to the baseline angiogram for evaluation of the primary endpoint.
- Secondary Outcome Measures
Name Time Method Occurrence of vasospasm-related morbidity, and mortality of all causes defined as the occurence of delayed ischemic neurological deficits (DIND) due to vasospasm (based on investigator assessments) within 14 days post-aneurysm rupture OR Within 14 days Clinical outcome at 12 weeks post-aneurysm rupture as measured by the Modified Rankin Scale (mRS) score At 12 weeks Occurrence of vasospasm-related morbidity, and mortality of all causes defined as occurrence of use of rescue medication due to vasospasm within 14 days post-aneurysm rupture Within 14 days Clinical outcome at 12 weeks post-aneurysm rupture as measured bythe Glasgow Outcome Scale - Extended Version (GOSE) score At 12 weeks Occurrence of vasospasm-related morbidity, and mortality of all causes defined as the occurence of new cerebral infarct within first 6 weeks post-aneurysm rupture based on local investigator reading of post-baseline CT scans OR Within 6 weeks Occurrence of vasospasm-related morbidity, and mortality of all causes defined as the occurrence of death of any cause within the first 6 weeks post-aneurysm rupture OR Within 6 weeks
Trial Locations
- Locations (16)
Dr. Aldrich
🇺🇸Baltimore, Maryland, United States
Dr. Giuseppe Lanzino
🇺🇸Peoria, Illinois, United States
Dr. Horner
🇺🇸Indianapolis, Indiana, United States
Dr. Ogilvy
🇺🇸Boston, Massachusetts, United States
Dr. Zuccarello
🇺🇸Cincinnati, Ohio, United States
Dr. Woo
🇺🇸Cleveland, Ohio, United States
Dr. Ferguson
🇨🇦Toronto, Ontario, Canada
Dr. Rosenwasser
🇺🇸Philadelphia, Pennsylvania, United States
Dr. Bullock
🇺🇸Richmond, Virginia, United States
Dr. Wong
🇨🇦Calgary, Alberta, Canada
Dr. George A. Lopez
🇺🇸Houston, Texas, United States
Dr. Zager
🇺🇸Philadelphia, Pennsylvania, United States
Dr. Redekop
🇨🇦Vancouver, British Columbia, Canada
Dr. Findlay
🇨🇦Edmonton, Alberta, Canada
Dr. Bojanowski
🇨🇦Montreal, Quebec, Canada
Dr. Fleetwood
🇨🇦Halifax, Nova Scotia, Canada