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Clazosentan in Preventing the Occurrence of Cerebral Vasospasm Following an Aneurysmal Subarachnoid Hemorrhage (aSAH) (CONSCIOUS-1)

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: May 18, 2005
Last Update Posted: February 15, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
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.

Condition Intervention Phase
Vasospasm Following Subarachnoid Hemorrhage Aneurysmal Subarachnoid Hemorrhage Intracranial Vasospasm Drug: clazosentan Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: A Phase IIb, Multi-center, International, Double-blind, Randomized, Placebo-controlled, Parallel-group, Dose-finding Study for the Prevention of Cerebral Vasospasm After aSAH by Intravenous Administration of Clazosentan, a Selective ETA Receptor Antagonist

Resource links provided by NLM:

Further study details as provided by Actelion:

Primary Outcome Measures:
  • To assess the efficacy of 3 dose levels (1 mg/h, 5 mg/h and 15 mg/h) of clazosentan in preventing the occurrence of cerebral vasospasm following aSAH.

Secondary Outcome Measures:
  • To assess the ability of clazosentan to reduce the occurrence of early morbidity/mortality.
  • To assess the effect of clazosentan on clinical outcome.
  • To assess the safety and tolerability of three dose levels of clazosentan.

Enrollment: 413
Study Start Date: January 2005
Study Completion Date: March 2006
Primary Completion Date: March 2006 (Final data collection date for primary outcome measure)

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Female patients aged 18 to 70 years (inclusive) or male patients aged 45 to 70 (inclusive) or males aged 18 to 44 (inclusive) who are surgically or naturally sterile or can personally sign the core Informed Consent
  • 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.
  • Patients with a diffuse or localized thick subarachnoid clot on baseline CT scan.
  • Start of screening within 48 hours post onset of aSAH clinical symptoms.
  • WFNS Grades I-IV, and those Grade V patients who improve to Grade IV or less after ventriculostomy.

Exclusion Criteria:

  • Patients with SAH due to other causes (e.g., trauma or rupture of fusiform or mycotic aneurysms)
  • Patients with intraventricular or intracerebral blood, in the absence of subarachnoid blood.
  • No visualized clot or presence of only localized thin clot on CT
  • Presence of any degree of cerebral vasospasm on screening angiogram
  Contacts and Locations
Information from the National Library of Medicine

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): NCT00111085

United States, Illinois
Dr. Giuseppe Lanzino
Peoria, Illinois, United States
United States, Indiana
Dr. Horner
Indianapolis, Indiana, United States
United States, Maryland
Dr. Aldrich
Baltimore, Maryland, United States
United States, Massachusetts
Dr. Ogilvy
Boston, Massachusetts, United States
United States, Ohio
Dr. Zuccarello
Cincinnati, Ohio, United States
Dr. Woo
Cleveland, Ohio, United States
United States, Pennsylvania
Dr. Rosenwasser
Philadelphia, Pennsylvania, United States
Dr. Zager
Philadelphia, Pennsylvania, United States
United States, Texas
Dr. George A. Lopez
Houston, Texas, United States
United States, Virginia
Dr. Bullock
Richmond, Virginia, United States
Canada, Alberta
Dr. Wong
Calgary, Alberta, Canada
Dr. Findlay
Edmonton, Alberta, Canada
Canada, British Columbia
Dr. Redekop
Vancouver, British Columbia, Canada
Canada, Ontario
Dr. Ferguson
Toronto, Ontario, Canada
Canada, Quebec
Dr. Bojanowski
Montreal, Quebec, Canada
Dr. Fleetwood
Halifax, Nova Scotia, Canada
Sponsors and Collaborators
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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. Epub 2016 Nov 8.
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, Mišić 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.

ClinicalTrials.gov Identifier: NCT00111085     History of Changes
Other Study ID Numbers: AC-054-201
First Submitted: May 17, 2005
First Posted: May 18, 2005
Last Update Posted: February 15, 2010
Last Verified: February 2010

Keywords provided by Actelion:
aneurysmal subarachnoid hemorrhage (aSAH)
delayed ischemic neurological deficits (DIND)
computer tomography scan (CT scan)
digital subtraction angiography (DSA)
endothelin A receptor

Additional relevant MeSH terms:
Subarachnoid Hemorrhage
Vasospasm, Intracranial
Pathologic Processes
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases

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