Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
577 participants
INTERVENTIONAL
2009-07-01
2011-01-01
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Clazosentan 5 mg/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 5 m/h
Continuous intravenous infusion of clazosentan (5 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
Clazosentan 15 mg/h
Continuous intravenous infusion of clazosentan clazosentan (15 mg/h)
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
Placebo
Continuous intravenous infusion of placebo-matching clazosentan
Interventions
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Clazosentan 5 m/h
Continuous intravenous infusion of clazosentan (5 mg/h)
Clazosentan 15 mg/h
Continuous intravenous infusion of clazosentan clazosentan (15 mg/h)
Placebo
Continuous intravenous infusion of placebo-matching clazosentan
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Patients with a ruptured saccular aneurysm, confirmed by angiography (digital subtraction angiography \[DSA\] or computed tomography angiography \[CTA\], investigator's assessment), and which has been successfully\* secured by endovascular coiling. The time of aneurysm rupture must be known or possible to estimate with a reasonable degree of certainty.
3. World Federation of Neurological Surgeons (WFNS) grade I-IV measured prior to the endovascular coiling procedure, and which does not worsen to grade V post-procedure (based on regular Glasgow Coma Scale \[GCS\])
4. Patients with any thick clot (short axis \> or = 4 mm) on baseline CT scan (investigator's assessment).
5. Women of childbearing potential must have a negative serum pregnancy test and must use a reliable method of contraception during the 12 weeks following study drug discontinuation.
6. Written informed consent to participate in the study must be obtained from the patient or a legal representative prior to initiation of any study-mandated procedure and randomization.
Exclusion Criteria
2. Giant aneurysms (height or width \> or = 25 mm).
3. Intraventricular or intracerebral blood, in absence of subarachnoid blood, or or with only a thin clot (short axis \< 4 mm)
4. Cerebral vasospasm on angiography (investigator's assessment) prior to endovascular coiling (intraprocedural cerebral vasospasm is not an exclusion criterion).
5. A major complication during the endovascular coiling procedure, such as massive intracranial bleeding, intracranial thromboembolism, coil migration, aneurysm perforation or rupture, arterial dissection, major arterial occlusion, a large territorial cerebral infarct defined as involving \> 1/3 of a vascular territory, or a new major neurological deficit post-procedure (e.g., hemiplegia or aphasia lasting \> or = 12 hours post-aneurysm coiling)\*.
6. Current ruptured aneurysm previously secured (successfully or not) by clipping.
7. Coiling material used, which has not been approved by local health authorities.
8. Use of liquid embolism aneurysmal treatment or flow diverting device.
9. Several aneurysms among which the ruptured one cannot be identified with certainty and which are not all secured during the coiling procedure.
10. No end-of-procedure DSA.
11. Another securing procedure planned for any aneurysm between randomization and Week 12 post-aSAH.
12. Study drug start \>56 hours after the aneurysm rupture.
13. Known, at time of screening, that certain follow-up, or protocol-mandated imaging assessments will not be feasible.
14. Hypotension (systolic blood pressure \< or = 90 mmHg) refractory to treatment.
15. Aspiration pneumonia.
16. Pulmonary edema or severe cardiac failure requiring inotropic support at time of randomization.
17. Any severe or unstable concomitant condition or disease (e.g., known significant neurological deficit, cancer, hematological, coronary disease, psychiatric disorder), which would affect assessment of the safety or efficacy of the study drug (investigator's opinion).
18. Significant kidney disease defined by plasma creatinine \> or = 2.5 mg/dL (221 micromol/l) and/or liver disease defined by total bilirubin \> 2-fold Upper Limit of Normal as measured at local laboratory, and/or known diagnosis or clinical suspicion of liver cirrhosis.
19. Infusion of i.v. nimodipine or i.v. nicardipine must have these drugs discontinued at least 4 hours prior to initiation of study treatment.
20. Infusion of i.v. fasudil within 24-hour period preceding planned start of study drug initiation.
21. Start of statins less than 2 weeks prior to admission must have them discontinued prior to study drug initiation.
22. Infusion of cyclosporin A or other calcineurin inhibitors (e.g., tacrolimus), or patients for whom it is known at the time of randomization that these medications will be started during the study drug infusion period.
23. Intake of an investigational product including investigational coil material within 28 days prior to randomization or those who have already participated in current study or CONSCIOUS-2 (AC-054-301).
24. Unlikely event to comply with protocol (e.g., unable to return for follow-up visits).
25. Known hypersensitivity to other endothelin receptor antagonists.26.current alcohol or drug abuse/dependence.
* "Large territorial infarct" refers to infarcts detected during the endovascular coiling procedure or immediately post-procedure (i.e., CT performed for suspicion of cerebral infarct or other complication). This does not imply having to wait 24-48 hours post-procedure to perform the protocol-mandated CT scan in order to randomize a patient. Evaluation for a new major neurological deficit post-procedure implies reversal of sedation and performance of a GCS examination (verbal scores in intubated patients may be extrapolated from the eye-opening and motor scores using predefined values). If a new major neurological deficit does not improve within 12 hours after the coiling procedure, the patient cannot be included.
18 Years
75 Years
ALL
No
Sponsors
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Idorsia Pharmaceuticals Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Sebastien Roux, MD
Role: STUDY_DIRECTOR
Actelion
Locations
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Glendale Adventist Medical Center
Glendale, California, United States
UCSF Medical Centre
San Francisco, California, United States
Stanford Hospital and Clinis
Stanford, 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
Rush University Medical Center
Chicago, Illinois, United States
University of Illnois
Chicago, Illinois, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Boston Medical Centre
Boston, Massachusetts, United States
William Beaumont Hospital
Royal Oak, Michigan, United States
Mayo Clinic
Rochester, Minnesota, United States
Barnes_Jewish Hospital
St Louis, Missouri, United States
Capital Health System Inc. d/b/a The Stroke and Cerebrovascular Center of New Jersey
Trenton, New Jersey, 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
Duke University Medical Center
Durham, North Carolina, United States
University of Cincinnati
Cincinnati, Ohio, United States
University Hospitals Case Medical Center
Cleveland, Ohio, United States
Oklahoma University Health Sciences Center
Oklahoma City, Oklahoma, United States
Oregon Health & Science University
Portland, Oregon, United States
Thomas Jefferson University School of Medicine
Philadelphia, Pennsylvania, United States
Temple University Hospital
Philadelphia, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
University of Texas Southwestern Zale Lipshy Hospital
Dallas, Texas, United States
Univ. of VA Health System
Charlottesville, Virginia, United States
Virginia Commonwealth University Medical Centre
Richmond, Virginia, United States
Virginia Commonwealth University
Richmond, Virginia, United States
Hospital Aleman
Buenos Aires, , Argentina
Clinica De Sol
Buenos Aires, , Argentina
ENERI
Buenos Aires, , Argentina
Gold Coast Hospital
Southport, Queensland, Australia
Royal Brisbane & Women's Hosptal
Brisbane, , Australia
Royal Prince Alfred Hosptial
Camperdown, , Australia
Monash Medical Centre
Clayton, , Australia
Princess Alexandra Hospital
Woolloongabba, , Australia
Landeskrankenhaus und Medizinische Universitat
Graz, , Austria
Medizinsche Universitat Innsbruck
Innsbruck, , Austria
University Fur Neurochirurgie, SALK, Christian Doppler Hospital
Salzburg, , Austria
AKH University of Vienna, Medical Univ. Of Neurosurgery
Vienna, , Austria
UZ Antwerpen
Antwerp, , Belgium
ULB Erasme
Brussels, , Belgium
UZ Brussels
Brussels, , Belgium
UCL Saint-Luc
Brussels, , Belgium
UZ Brussels
Brussels, , Belgium
UZ Gent
Ghent, , Belgium
UZ Gasthuisberg
Leuven, , Belgium
Hospital das Clinicas da UFMG
Belo Horizonte, , Brazil
Hospital de Clinicas da Universidade Federal do Parana
Curitiba, , Brazil
Clinica de Neurologia de
Joinville, , Brazil
Hospital de Clínicas de Niteroí
Niteroí, , Brazil
Hospital Moinhos de Vento
Porto Alegre, , Brazil
Hospital Santa Marcelina
São Paulo, , Brazil
Santa Case de Misericordia de Sobral
Sobral, , Brazil
University of Calgary - Foothills Medical Center
Calgary, Alberta, Canada
University of Alberta Hospital
Edmonton, Alberta, Canada
Vancouver Hospital & Health Sciences
Vancouver, British Columbia, Canada
QEII Heath Sciences Center - Halifax Infirmary
Halifax, Nova Scotia, Canada
Hamilton General Hospital
Toronto, Ontario, Canada
St. Michael's Hospital, University of Toronto
Toronto, Ontario, Canada
CHUM Hospital - Notre Dame
Montreal, Quebec, Canada
Royal University Hospital
Saskatoon, Saskatchewan, Canada
Hopital de I'Enfant-Jesus
Québec, , Canada
Hospital Regional de Concepción
Concepción, , Chile
Institute de Neurocirugia
Santiago, , Chile
Hospital Clinico Pontificia Universidad Católica de Chile
Santiago, , Chile
Clinica Davila
Santiago, , Chile
Hospital Carlos Van Buren
Valparaíso, , Chile
Fakultni nemocnice Bmo
Brno, , Czechia
Nemocnice Ceske Budejovice
České Budějovice, , Czechia
Fakultní nemocnice Ostrava
Ostrava, , Czechia
Fakultni nemocnice Ostrava
Ostrava, , Czechia
Nemocnice Na Homolce
Prague, , Czechia
ÚVN Praha
Prague, , Czechia
Fakultni nemocnice Homoice
Prague, , Czechia
Masarykova nemocnice Usti n. Labem
Ústí nad Labem, , Czechia
The Neuroscience Center, Copenhagen University Hospital
Copenhagen, , Denmark
Glostrup Hospital
Glostrup Municipality, , Denmark
Odense University Hospital
Odense, , Denmark
Helsinki University Central Hospital
Helsinki, , Finland
Tampere University Central Hospital (TAYS)
Tampere, , Finland
CHU d'Angers
Angers, , France
Hopital Pellegrin
Bordeaux, , France
Hopital neurologique et Neuro-Chirurgical Pierre Wertheimer
Bron, , France
Hopital Henru Mondor
Créteil, , France
Hopital General
Dijon, , France
Hopital de la Timone - CHU de Marseille
Marseille, , France
Hopital Gui de Chauliac
Montpellier, , France
Hopital central
Nancy, , France
Universitatsklinikum Augsburg Clinic for Diagnostic Radiology and Neuroradiology
Augsburg, , Germany
Charite Universitatsmedzin Berlin
Berlin, , Germany
Universitatsklinikum Bonn
Bonn, , Germany
University of Bonn Medical Center
Bonn, , Germany
Klinik imd Poliklinik fur Neurochirurgie
Dresden, , Germany
Universitaet Erlangen-Nuerberg Klinik fur Neurologie
Erlangen, , Germany
University Hospital of Essen
Essen, , Germany
Universitatsklinik Frankfurt, Klinik und Poliklinik f. Neurochirurgie
Frankfurt, , Germany
Neuroradiologie der Universitatsklinik Freiburg
Freiburg im Breisgau, , Germany
Universitatsklinikum Hamburg-Eppendorf
Hamburg, , Germany
Neurochirurggische Universitatsklinik des Heidelberg
Heidelberg, , Germany
Klinik und Poliklinik fur Neurochirurgie
Leipzig, , Germany
Thechnical University - Klinikum rechts der Isar
Munich, , Germany
University Regensburg
Regensburg, , Germany
Queen Mary Hospital
Hong Kong, , Hong Kong
Prince od Wales Hospital
Shatin, , Hong Kong
Borsod-Abauj-Zemplen County Hospital and University Teaching Hospital
Miskolc, Borsod-Abauj Zemplen county, Hungary
University of Pecs, Faculty of Medicine Neurosurgery Clinic
Pécs, , Hungary
University of Szeged, Faculty of Medicine
Pécs, , Hungary
Post Graduate Institute of Medical Education and Research
Chandigarh, , India
CARE Hospital
Hyderabad, , India
King Edward Memorial Hospital
Pune, , India
Rambam Medical Centre
Haifa, , Israel
Hadassah Universtity Medical Center
Jerusalem, , Israel
Sheba Medical Centre
Tel Litwinsky, , Israel
Osepedale Maggiore Bellaria
Bologna, , Italy
Azienda Ospedaliera di Careggi
Florence, , 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
Universitetssykehuset Nord-Norge
Tromsø, , Norway
Szpital Akademii Medycznej w Gdansku
Gdansk, , Poland
Samodzielny Publiczny Centralny Szpital Kliniczy w Warszawie
Warsaw, , Poland
National University Hospital
Singapore, , Singapore
National Neuroscience Institute
Singapore, , Singapore
University Clinical Centre Ljubljana
Ljubljana, , Slovenia
General Hospital Maribor
Maribor, , 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 Universitario 12 se Octubre
Madrid, , Spain
Hospital de Son Dureta
Palma de Mallorca, , Spain
Sahlgrenska University Hospital
Gothenburg, , Sweden
Linkoping University Hospital
Linköping, , Sweden
Lund University Hospital
Lund, , Sweden
Kantonsspital Aarau
Aarau, , Switzerland
Universitatsklinik Bern
Bern, , Switzerland
Geneva University Hospital
Geneva, , Switzerland
Universitatsspital Zurich
Zurich, , Switzerland
National Taiwan University Hospital
Taipei, , Taiwan
Taipei Veterans General Hospital
Taipei, , Taiwan
Countries
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References
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Macdonald RL, Higashida RT, Keller E, Mayer SA, Molyneux A, Raabe A, Vajkoczy P, Wanke I, Bach D, Frey A, Nowbakht P, Roux S, Kassell N. Randomized trial of clazosentan in patients with aneurysmal subarachnoid hemorrhage undergoing endovascular coiling. Stroke. 2012 Jun;43(6):1463-9. doi: 10.1161/STROKEAHA.111.648980. Epub 2012 Mar 8.
Mayer SA, Aldrich EF, Bruder N, Hmissi A, Macdonald RL, Viarasilpa T, Marr A, Roux S, Higashida RT. Thick and Diffuse Subarachnoid Blood as a Treatment Effect Modifier of Clazosentan After Subarachnoid Hemorrhage. Stroke. 2019 Oct;50(10):2738-2744. doi: 10.1161/STROKEAHA.119.025682. Epub 2019 Aug 9.
Other Identifiers
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AC-054-302
Identifier Type: -
Identifier Source: org_study_id
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