Clazosentan in Aneurysmal Subarachnoid Hemorrhage
- Conditions
- Aneurysmal Subarachnoid Hemorrhage
- Interventions
- Registration Number
- NCT00940095
- Lead Sponsor
- Idorsia Pharmaceuticals Ltd.
- Brief Summary
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:
1. Death (all causes).
2. 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.
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. 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 577
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Continuous intravenous infusion of placebo matching clazosentan started within 56 hours post-aSAH and scheduled to continue until Day 14 post-aSAH, or at least until Day 10 post-aSAH, for patients discharged before Day 14 Clazosentan 5 mg/h Clazosentan 5 m/h Continuous intravenous infusion of clazosentan (5 mg/h) started within 56 hours post-aSAH and scheduled to continue until Day 14 post-aSAH, or at least until Day 10 post-aSAH, for patients discharged before Day 14 Clazosentan 15 mg/h Clazosentan 15 mg/h Continuous intravenous infusion of clazosentan (15 mg/h) started within 56 hours post-aSAH and scheduled to continue until Day 14 post-aSAH, or at least until Day 10 post-aSAH, for patients discharged before Day 14
- Primary Outcome Measures
Name Time Method Cerebral vasospasm-related morbidity and mortality of all-causes as defined by the protocol Within 6 weeks post-aSAH
- Secondary Outcome Measures
Name Time Method Glasgow Outcome Scale Extended (GOSE) at Week 12 post-aSAH, dichotomized into good (score > 4) and poor (score ≤ 4) outcome. Week 12 post-aSAH
Trial Locations
- Locations (144)
Stanford Hospital and Clinis
🇺🇸Stanford, California, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
University of Cincinnati
🇺🇸Cincinnati, Ohio, United States
The Neuroscience Center, Copenhagen University Hospital
🇩🇰Copenhagen, Denmark
Odense University Hospital
🇩🇰Odense, Denmark
AKH University of Vienna, Medical Univ. Of Neurosurgery
🇦🇹Vienna, Austria
University of Szeged, Faculty of Medicine
ðŸ‡ðŸ‡ºPecs, Hungary
Post Graduate Institute of Medical Education and Research
🇮🇳Chandigarh, India
Samodzielny Publiczny Centralny Szpital Kliniczy w Warszawie
🇵🇱Warszawa, Poland
National Neuroscience Institute
🇸🇬Singapore, Singapore
General Hospital Maribor
🇸🇮Maribor, Slovenia
Taipei Veterans General Hospital
🇨🇳Taipei, Taiwan
National Taiwan University Hospital
🇨🇳Taipei, Taiwan
Hospital Carlos Van Buren
🇨🇱Valparaiso, Chile
Hopital General
🇫🇷Dijon, France
Thechnical University - Klinikum rechts der Isar
🇩🇪Munich, Germany
Temple University Hospital
🇺🇸Philadelphia, Pennsylvania, United States
Glendale Adventist Medical Center
🇺🇸Glendale, California, United States
Colorado Neurological Institute
🇺🇸Englewood, Colorado, United States
Yale Univerity School of Medicine
🇺🇸New Haven, Connecticut, United States
University of South Florida
🇺🇸Tampa, Florida, United States
University of Illnois
🇺🇸Chicago, Illinois, United States
Boston Medical Centre
🇺🇸Boston, Massachusetts, United States
William Beaumont Hospital
🇺🇸Royal Oak, Michigan, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
Columbia University Medical Center
🇺🇸New York, New York, United States
New York Presbyteruan Hospital - Weill Cornell Medical Centre
🇺🇸New York, New York, United States
State University of New York at Stony Brook
🇺🇸Stony Brook, New York, United States
University Hospitals Case Medical Center
🇺🇸Cleveland, Ohio, United States
Oklahoma University Health Sciences Center
🇺🇸Oklahoma City, Oklahoma, United States
Thomas Jefferson University School of Medicine
🇺🇸Philadelphia, Pennsylvania, United States
Oregon Health & Science University
🇺🇸Portland, Oregon, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
Hospital Aleman
🇦🇷Buenos Aires, Argentina
Virginia Commonwealth University Medical Centre
🇺🇸Richmond, Virginia, United States
Virginia Commonwealth University
🇺🇸Richmond, Virginia, United States
ENERI
🇦🇷Buenos Aires, Argentina
Clinica De Sol
🇦🇷Buenos Aires, Argentina
Landeskrankenhaus und Medizinische Universitat
🇦🇹Graz, Austria
Royal Brisbane & Women's Hosptal
🇦🇺Brisbane, Australia
Gold Coast Hospital
🇦🇺Southport, Queensland, Australia
Princess Alexandra Hospital
🇦🇺Woolloongabba, Australia
Monash Medical Centre
🇦🇺Clayton, Australia
UZ Antwerpen
🇧🇪Antwerp, Belgium
Medizinsche Universitat Innsbruck
🇦🇹Innsbruck, Austria
University Fur Neurochirurgie, SALK, Christian Doppler Hospital
🇦🇹Salzburg, Austria
ULB Erasme
🇧🇪Brussels, Belgium
UCL Saint-Luc
🇧🇪Brussels, Belgium
UZ Brussels
🇧🇪Brussels, Belgium
UZ Gasthuisberg
🇧🇪Leuven, Belgium
Hospital das Clinicas da UFMG
🇧🇷Belo Horizonte, Brazil
UZ Gent
🇧🇪Gent, Belgium
Hospital de Clinicas da Universidade Federal do Parana
🇧🇷Curitiba, Brazil
Clinica de Neurologia de
🇧🇷Joinville, Brazil
Hospital Santa Marcelina
🇧🇷Sao Paulo, Brazil
Hospital de ClÃnicas de NiteroÃ
🇧🇷NiteroÃ, Brazil
Hospital Moinhos de Vento
🇧🇷Porto Alegre, Brazil
Santa Case de Misericordia de Sobral
🇧🇷Sobral, Brazil
University of Alberta Hospital
🇨🇦Edmonton, Alberta, Canada
Vancouver Hospital & Health Sciences
🇨🇦Vancouver, British Columbia, Canada
University of Calgary - Foothills Medical Center
🇨🇦Calgary, Alberta, Canada
QEII Heath Sciences Center - Halifax Infirmary
🇨🇦Halifax, Nova Scotia, Canada
Royal University Hospital
🇨🇦Saskatoon, Saskatchewan, Canada
Hamilton General Hospital
🇨🇦Toronto, Ontario, Canada
St. Michael's Hospital, University of Toronto
🇨🇦Toronto, Ontario, Canada
CHUM Hospital - Notre Dame
🇨🇦Montreal, Quebec, Canada
Hopital de I'Enfant-Jesus
🇨🇦Quebec, Canada
Institute de Neurocirugia
🇨🇱Santiago, Chile
Hospital Regional de Concepción
🇨🇱Concepcion, Chile
Hospital Clinico Pontificia Universidad Católica de Chile
🇨🇱Santiago, Chile
Clinica Davila
🇨🇱Santiago, Chile
Fakultni nemocnice Bmo
🇨🇿Brno, Czechia
Nemocnice Ceske Budejovice
🇨🇿Ceske Budejovice, Czechia
Fakultnà nemocnice Ostrava
🇨🇿Ostrava, Czechia
Nemocnice Na Homolce
🇨🇿Praha, Czechia
Fakultni nemocnice Ostrava
🇨🇿Ostrava, Czechia
ÚVN Praha
🇨🇿Praha, Czechia
Fakultni nemocnice Homoice
🇨🇿Praha, Czechia
Masarykova nemocnice Usti n. Labem
🇨🇿Usti nad Labem, Czechia
Helsinki University Central Hospital
🇫🇮Helsinki, Finland
Glostrup Hospital
🇩🇰Glostrup, Denmark
Tampere University Central Hospital (TAYS)
🇫🇮Tampere, Finland
CHU d'Angers
🇫🇷Angers Cedex 9, France
Hopital Pellegrin
🇫🇷Bordeaux cedex, France
Hopital Henru Mondor
🇫🇷Creteil, France
Hopital de la Timone - CHU de Marseille
🇫🇷Marseille cedex 5, France
Hopital Gui de Chauliac
🇫🇷Montpellier, France
Universitatsklinikum Augsburg Clinic for Diagnostic Radiology and Neuroradiology
🇩🇪Augsburg, Germany
Universitatsklinikum Bonn
🇩🇪Bonn, Germany
Charite Universitatsmedzin Berlin
🇩🇪Berlin, Germany
Klinik imd Poliklinik fur Neurochirurgie
🇩🇪Dresden, Germany
University of Bonn Medical Center
🇩🇪Bonn, Germany
Universitaet Erlangen-Nuerberg Klinik fur Neurologie
🇩🇪Erlangen, Germany
University Hospital of Essen
🇩🇪Essen, Germany
Universitatsklinik Frankfurt, Klinik und Poliklinik f. Neurochirurgie
🇩🇪Frankfurt, Germany
Klinik und Poliklinik fur Neurochirurgie
🇩🇪Leipzig, Germany
Universitatsklinikum Hamburg-Eppendorf
🇩🇪Hamburg, Germany
University Regensburg
🇩🇪Regensburg, Germany
Borsod-Abauj-Zemplen County Hospital and University Teaching Hospital
ðŸ‡ðŸ‡ºMiskolc, Borsod-Abauj-Zemplen, Hungary
Queen Mary Hospital
ðŸ‡ðŸ‡°Hong Kong, Hong Kong
University of Pecs, Faculty of Medicine Neurosurgery Clinic
ðŸ‡ðŸ‡ºPecs, Hungary
CARE Hospital
🇮🇳Hyderabad, India
King Edward Memorial Hospital
🇮🇳Pune, India
Sheba Medical Centre
🇮🇱Tel Hashomer, Israel
Hadassah Universtity Medical Center
🇮🇱Jerusalem, Israel
Rambam Medical Centre
🇮🇱Haifa, Israel
Osepedale Maggiore Bellaria
🇮🇹Bologna, Italy
Azienda Ospedaliera di Careggi
🇮🇹Firenze, Italy
Azienda Osepedaliera San Giovanni - Addolorata
🇮🇹Rome, Italy
Ospedale Maggiore
🇮🇹Verona, Italy
Instituto Nacional de Neurologia y Neurocirugia
🇲🇽Mexico City, Mexico
Hospital Universitario "Dr. Jose Eleuterio Gonzalez" Universidad Autonoma de Nuevo Leon
🇲🇽Monterrey, Mexico
Elisabeth Ziekenhuis
🇳🇱Tilburg, Netherlands
Haukeland University Hospital, Helse Bergen HF
🇳🇴Bergen, Norway
Ulleval Univ Hosp
🇳🇴Oslo, Norway
National University Hospital
🇸🇬Singapore, Singapore
Universitetssykehuset Nord-Norge
🇳🇴Tromso, Norway
Szpital Akademii Medycznej w Gdansku
🇵🇱Gdansk, Poland
University Clinical Centre Ljubljana
🇸🇮Ljubljana, Slovenia
Hospital Vali d' Hebron
🇪🇸Barcelona, Spain
Hospital Universitari de Bellvitge
🇪🇸Barcelona, Spain
Complejo Hospotalario Virgen de las Nieves-Hospital de Rehabilitacion y Traumatologia
🇪🇸Granada, Spain
Hospital de Son Dureta
🇪🇸Palma de Mallorca, Spain
Lund University Hospital
🇸🇪Lund, Sweden
Kantonsspital Aarau
🇨ðŸ‡Aarau, Switzerland
Hospital Universitario 12 se Octubre
🇪🇸Madrid, Spain
Sahlgrenska University Hospital
🇸🇪Goteborg, Sweden
Linkoping University Hospital
🇸🇪Linkoping, Sweden
Geneva University Hospital
🇨ðŸ‡Geneva, Switzerland
Universitatsspital Zurich
🇨ðŸ‡Zurich, Switzerland
Universitatsklinik Bern
🇨ðŸ‡Bern, Switzerland
UCSF Medical Centre
🇺🇸San Francisco, California, United States
Barnes_Jewish Hospital
🇺🇸Saint Louis, Missouri, United States
Rush University Medical Center
🇺🇸Chicago, Illinois, United States
Capital Health System Inc. d/b/a The Stroke and Cerebrovascular Center of New Jersey
🇺🇸Trenton, New Jersey, United States
University of Texas Southwestern Zale Lipshy Hospital
🇺🇸Dallas, Texas, United States
Univ. of VA Health System
🇺🇸Charlottesville, Virginia, United States
Neurochirurggische Universitatsklinik des Heidelberg
🇩🇪Heidelberg, Germany
Royal Prince Alfred Hosptial
🇦🇺Camperdown, Australia
Hopital neurologique et Neuro-Chirurgical Pierre Wertheimer
🇫🇷Bron, France
Hopital central
🇫🇷Nancy, France
Neuroradiologie der Universitatsklinik Freiburg
🇩🇪Freiburg, Germany
Prince od Wales Hospital
ðŸ‡ðŸ‡°Shatin, Hong Kong