Clazosentan in Preventing the Occurrence of Cerebral Vasospasm Following an Aneurysmal Subarachnoid Hemorrhage (aSAH)
NCT ID: NCT00111085
Last Updated: 2018-07-10
Study Results
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Basic Information
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COMPLETED
PHASE2
413 participants
INTERVENTIONAL
2005-01-10
2006-03-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
Study Groups
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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 1 mg/h
Subjects receive intravenous clazosentan at a rate of 1 mg/h starting within 56 hours maximum after aneurysm rupture and continuing until Day 14 post-aneurysm rupture
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
Clazosentan 5 mg/h
Subjects receive intravenous clazosentan at a rate of 5 mg/h starting within 56 hours maximum after aneurysm rupture and continuing until Day 14 post-aneurysm rupture
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 15 mg/h
Subjects receive intravenous clazosentan at a rate of 15 mg/h starting within 56 hours maximum after aneurysm rupture and continuing until Day 14 post-aneurysm rupture
Placebo
intravenous placebo starting within 56 hours maximum after aneurysm rupture and continuing until Day 14 post-aneurysm rupture
Placebo
Subjects receive intravenous placebo starting within 56 hours maximum after aneurysm rupture and continuing until Day 14 post-aneurysm rupture
Interventions
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Clazosentan 1 mg/h
Subjects receive intravenous clazosentan at a rate of 1 mg/h starting within 56 hours maximum after aneurysm rupture and continuing until Day 14 post-aneurysm rupture
Clazosentan 5 mg/h
Subjects receive intravenous clazosentan at a rate of 5 mg/h starting within 56 hours maximum after aneurysm rupture and continuing until Day 14 post-aneurysm rupture
Clazosentan 15 mg/h
Subjects receive intravenous clazosentan at a rate of 15 mg/h starting within 56 hours maximum after aneurysm rupture and continuing until Day 14 post-aneurysm rupture
Placebo
Subjects receive intravenous placebo starting within 56 hours maximum after aneurysm rupture and continuing until Day 14 post-aneurysm rupture
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Patients with a ruptured saccular aneurysm that has been confirmed by digital subtraction angiography (DSA) and for which clipping or coiling (endovascular obliteration) is possible.
3. Patients with a diffuse or localized thick subarachnoid clot on baseline CT scan. Measurements defining clot thickness and extension are as follows: Diffuse: Clot with long axis \>= 20 mm, or any clot if present in both hemispheres Localized: Clot with long axis \< 20 mm Thick: Clot with short axis \>= 4 mm Thin: Clot with short axis \< 4 mm
4. Start of screening within 48 hours post onset of aSAH clinical symptoms
5. World Federation of Neurological Surgeons (WFNS) Grades I-IV, and those Grade V patients who improve to Grade IV or less after ventriculostomy
6. In the case of multiple aneurysms, the aneurysm that has ruptured is identified with a high likelihood during the screening period
7. Women of childbearing potential with pre-treatment negative serum pregnancy test
8. Patient is able to start the study drug infusion within 56 hours after the rupture of the aneurysm, and the procedure option (clipping or coiling) must either be started within a maximum of 12 hours after the start of study drug infusion or should have been already performed
9. Written informed consent to participate in the study must be obtained from the patient or a legal representative prior to initiation of any study-related procedure and enrollment
Exclusion Criteria
2. Patients with intraventricular or intracerebral blood, in the absence of subarachnoid blood
3. No visualized clot or presence of only localized thin clot on CT (\< 20 mm x 4 mm)
4. Presence of any degree of cerebral vasospasm on screening angiogram
5. Patients with hypotension (systolic blood pressure (SBP) \<=90 mmHg) refractory to fluid therapy
6. Patients with neurogenic pulmonary edema or severe cardiac failure requiring inotropic support
7. Any severe or unstable concomitant condition or disease (e.g., known significant neurological deficit, cancer, hematological, or coronary disease), or chronic condition (e.g., psychiatric disorder) which, in the opinion of the Investigator, would affect the assessment of the safety or efficacy of the study drug
8. Advanced kidney and/or liver disease, as defined by plasma creatinine \>=2 mg/dl (177 micromol/l) and/or total bilirubin \> 3 mg/dl (51.3 micromol/l)
9. Any known or CT evidence of previous major cerebral damage (e.g., stroke \[\> 2 cm\], traumatic brain injury \[\> 2 cm\], previously treated cerebral aneurysm, arterial venous malformation \[AVM\]), or other preexisting cerebrovascular disorders, which may affect accurate diagnosis and evaluation of SAH
10. Patients receiving prophylactic i.v. nimodipine or i.v. nicardipine. If present, these must be stopped at least 4 hours prior to initiation of the study treatment
11. Patients who have received thrombolytics, including intracisternal administration, intrathecal treatments and therapeutic hypothermia for treatment of the SAH
12. Patients who have received an investigational product within 28 days prior to randomization
13. Patients with current alcohol or drug abuse or dependence
18 Years
70 Years
ALL
No
Sponsors
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Idorsia Pharmaceuticals Ltd.
INDUSTRY
Responsible Party
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Locations
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Dr. Giuseppe Lanzino
Peoria, Illinois, United States
Dr. Horner
Indianapolis, Indiana, United States
Dr. Aldrich
Baltimore, Maryland, United States
Dr. Ogilvy
Boston, Massachusetts, United States
Dr. Zuccarello
Cincinnati, Ohio, United States
Dr. Woo
Cleveland, Ohio, United States
Dr. Rosenwasser
Philadelphia, Pennsylvania, United States
Dr. Zager
Philadelphia, Pennsylvania, United States
Dr. George A. Lopez
Houston, Texas, United States
Dr. Bullock
Richmond, Virginia, United States
Dr. Wong
Calgary, Alberta, Canada
Dr. Findlay
Edmonton, Alberta, Canada
Dr. Redekop
Vancouver, British Columbia, Canada
Dr. Ferguson
Toronto, Ontario, Canada
Dr. Bojanowski
Montreal, Quebec, Canada
Dr. Fleetwood
Halifax, Nova Scotia, , Canada
Countries
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References
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Eagles ME, Powell MF, Ayling OGS, Tso MK, Macdonald RL. Acute kidney injury after aneurysmal subarachnoid hemorrhage and its effect on patient outcome: an exploratory analysis. J Neurosurg. 2019 Jul 12;133(3):765-772. doi: 10.3171/2019.4.JNS19103. Print 2020 Sep 1.
Ayling OGS, Ibrahim GM, Alotaibi NM, Gooderham PA, Macdonald RL. Anemia After Aneurysmal Subarachnoid Hemorrhage Is Associated With Poor Outcome and Death. Stroke. 2018 Aug;49(8):1859-1865. doi: 10.1161/STROKEAHA.117.020260.
Ayling OG, Ibrahim GM, Alotaibi NM, Gooderham PA, Macdonald RL. Dissociation of Early and Delayed Cerebral Infarction After Aneurysmal Subarachnoid Hemorrhage. Stroke. 2016 Dec;47(12):2945-2951. doi: 10.1161/STROKEAHA.116.014794. Epub 2016 Nov 8.
Nassiri F, Ibrahim GM, Badhiwala JH, Witiw CD, Mansouri A, Alotaibi NM, Macdonald RL. A Propensity Score-Matched Study of the Use of Non-steroidal Anti-inflammatory Agents Following Aneurysmal Subarachnoid Hemorrhage. Neurocrit Care. 2016 Dec;25(3):351-358. doi: 10.1007/s12028-016-0266-6.
Tso MK, Ibrahim GM, Macdonald RL. Predictors of Shunt-Dependent Hydrocephalus Following Aneurysmal Subarachnoid Hemorrhage. World Neurosurg. 2016 Feb;86:226-32. doi: 10.1016/j.wneu.2015.09.056. Epub 2015 Sep 30.
Young JM, Morgan BR, Misic B, Schweizer TA, Ibrahim GM, Macdonald RL. A Partial Least-Squares Analysis of Health-Related Quality-of-Life Outcomes After Aneurysmal Subarachnoid Hemorrhage. Neurosurgery. 2015 Dec;77(6):908-15; discussion 915. doi: 10.1227/NEU.0000000000000928.
Ibrahim GM, Macdonald RL. The network topology of aneurysmal subarachnoid haemorrhage. J Neurol Neurosurg Psychiatry. 2015 Aug;86(8):895-901. doi: 10.1136/jnnp-2014-308992. Epub 2014 Oct 3.
Ibrahim GM, Morgan BR, Macdonald RL. Patient phenotypes associated with outcomes after aneurysmal subarachnoid hemorrhage: a principal component analysis. Stroke. 2014 Mar;45(3):670-6. doi: 10.1161/STROKEAHA.113.003078. Epub 2014 Jan 14.
Ibrahim GM, Fallah A, Macdonald RL. Clinical, laboratory, and radiographic predictors of the occurrence of seizures following aneurysmal subarachnoid hemorrhage. J Neurosurg. 2013 Aug;119(2):347-52. doi: 10.3171/2013.3.JNS122097. Epub 2013 Apr 12.
Ibrahim GM, Macdonald RL. Electrocardiographic changes predict angiographic vasospasm after aneurysmal subarachnoid hemorrhage. Stroke. 2012 Aug;43(8):2102-7. doi: 10.1161/STROKEAHA.112.658153. Epub 2012 Jun 7.
Ibrahim GM, Weidauer S, Vatter H, Raabe A, Macdonald RL. Attributing hypodensities on CT to angiographic vasospasm is not sensitive and unreliable. Stroke. 2012 Jan;43(1):109-12. doi: 10.1161/STROKEAHA.111.632745. Epub 2011 Oct 13.
Other Identifiers
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AC-054-201
Identifier Type: -
Identifier Source: org_study_id
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