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Aneurysmal Subarachnoid HemorrhagePhase 3CONSCIOUS-3NCT00940095

Clazosentan in Aneurysmal Subarachnoid Hemorrhage

A Phase 3 study testing Clazosentan 5 m/h and Clazosentan 15 mg/h in people with Aneurysmal Subarachnoid Hemorrhage, run by Idorsia Pharmaceuticals Ltd. at 145 sites in 28 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Aneurysmal Subarachnoid Hemorrhage
What is being tested?
Clazosentan 5 m/h and Clazosentan 15 mg/h
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
577 participants
Where
145 sitesin 28 countries
Study dates
1 Jul 2009to 1 Jan 2011
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Males and females aged 18 to 75 years (inclusive).
  • 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.
  • 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])
  • Patients with any thick clot (short axis > or = 4 mm) on baseline CT scan (investigator's assessment).
  • 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.
  • 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.

Who cannot join

  • Subarachnoid hemorrhage (SAH) due to causes other than saccular aneurysm.
  • Giant aneurysms (height or width > or = 25 mm).
  • Intraventricular or intracerebral blood, in absence of subarachnoid blood, or or with only a thin clot (short axis < 4 mm)
  • Cerebral vasospasm on angiography (investigator's assessment) prior to endovascular coiling (intraprocedural cerebral vasospasm is not an exclusion criterion).
  • 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)*.
  • Current ruptured aneurysm previously secured (successfully or not) by clipping.
Show all 26Show fewer
  • Coiling material used, which has not been approved by local health authorities.
  • Use of liquid embolism aneurysmal treatment or flow diverting device.
  • Several aneurysms among which the ruptured one cannot be identified with certainty and which are not all secured during the coiling procedure.
  • No end-of-procedure DSA.
  • Another securing procedure planned for any aneurysm between randomization and Week 12 post-aSAH.
  • Study drug start >56 hours after the aneurysm rupture.
  • Known, at time of screening, that certain follow-up, or protocol-mandated imaging assessments will not be feasible.
  • Hypotension (systolic blood pressure < or = 90 mmHg) refractory to treatment.
  • Aspiration pneumonia.
  • Pulmonary edema or severe cardiac failure requiring inotropic support at time of randomization.
  • 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).
  • 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.
  • Infusion of i.v. nimodipine or i.v. nicardipine must have these drugs discontinued at least 4 hours prior to initiation of study treatment.
  • Infusion of i.v. fasudil within 24-hour period preceding planned start of study drug initiation.
  • Start of statins less than 2 weeks prior to admission must have them discontinued prior to study drug initiation.
  • 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.
  • 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).
  • Unlikely event to comply with protocol (e.g., unable to return for follow-up visits).
  • 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.

Trial locations and contacts

145 sites in 28 countries.

145 sites in 28 countries

United States29 sites

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Boston Medical Centre

    Boston, Massachusetts, 02118

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • Univ. of VA Health System

    Charlottesville, Virginia, 22908

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • University of Illnois

    Chicago, Illinois, 60612

  • University of Cincinnati

    Cincinnati, Ohio, 45219

  • University Hospitals Case Medical Center

    Cleveland, Ohio, 44106

  • University of Texas Southwestern Zale Lipshy Hospital

    Dallas, Texas, 75390

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • Colorado Neurological Institute

    Englewood, Colorado, 80110

  • Glendale Adventist Medical Center

    Glendale, California, 91206

  • Yale Univerity School of Medicine

    New Haven, Connecticut, 06510

  • Columbia University Medical Center

    New York, New York, 10032

  • New York Presbyteruan Hospital - Weill Cornell Medical Centre

    New York, New York, 10065

  • Oklahoma University Health Sciences Center

    Oklahoma City, Oklahoma, 73104

  • Thomas Jefferson University School of Medicine

    Philadelphia, Pennsylvania, 19107

  • Temple University Hospital

    Philadelphia, Pennsylvania, 19140

  • Oregon Health & Science University

    Portland, Oregon, 97219

  • Virginia Commonwealth University Medical Centre

    Richmond, Virginia, 23284

  • Virginia Commonwealth University

    Richmond, Virginia, 980631

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • William Beaumont Hospital

    Royal Oak, Michigan, 48073

  • UCSF Medical Centre

    San Francisco, California, 94143

  • Barnes_Jewish Hospital

    St Louis, Missouri, 63110

  • Stanford Hospital and Clinis

    Stanford, California, 94305-5327

  • State University of New York at Stony Brook

    Stony Brook, New York, 11794-8122

  • University of South Florida

    Tampa, Florida, 33606

  • Capital Health System Inc. d/b/a The Stroke and Cerebrovascular Center of New Jersey

    Trenton, New Jersey, 08638

Other trials in United States

Germany14 sites

  • Universitatsklinikum Augsburg Clinic for Diagnostic Radiology and Neuroradiology

    Augsburg, 86156

  • Charite Universitatsmedzin Berlin

    Berlin, D-13353

  • Universitatsklinikum Bonn

    Bonn, 53105

  • University of Bonn Medical Center

    Bonn, 53105

  • Klinik imd Poliklinik fur Neurochirurgie

    Dresden, 1307

  • Universitaet Erlangen-Nuerberg Klinik fur Neurologie

    Erlangen, 91054

  • University Hospital of Essen

    Essen, 45122

  • Universitatsklinik Frankfurt, Klinik und Poliklinik f. Neurochirurgie

    Frankfurt, 60528

  • Neuroradiologie der Universitatsklinik Freiburg

    Freiburg im Breisgau, D-79106

  • Universitatsklinikum Hamburg-Eppendorf

    Hamburg, 20246

  • Neurochirurggische Universitatsklinik des Heidelberg

    Heidelberg, 69120

  • Klinik und Poliklinik fur Neurochirurgie

    Leipzig, 04103

  • Thechnical University - Klinikum rechts der Isar

    Munich, 81675

  • University Regensburg

    Regensburg, 93053

Other trials in Germany

Canada9 sites

  • University of Calgary - Foothills Medical Center

    Calgary, Alberta, T2N 1M9

  • University of Alberta Hospital

    Edmonton, Alberta, T6G 2B7

  • QEII Heath Sciences Center - Halifax Infirmary

    Halifax, Nova Scotia, B3H 3A7

  • CHUM Hospital - Notre Dame

    Montreal, Quebec, H2L 4M1

  • Hopital de I'Enfant-Jesus

    Québec, G1J 1Z4

  • Royal University Hospital

    Saskatoon, Saskatchewan, S7N 0W8

  • Hamilton General Hospital

    Toronto, Ontario, L8L 2X2

  • St. Michael's Hospital, University of Toronto

    Toronto, Ontario, M5C 3G7

  • Vancouver Hospital & Health Sciences

    Vancouver, British Columbia, V5Z 1M9

Other trials in Canada

Czechia8 sites

  • Fakultni nemocnice Bmo

    Brno, 625 00

  • Nemocnice Ceske Budejovice

    České Budějovice, 370 87

  • Fakultní nemocnice Ostrava

    Ostrava, 169 02

  • Fakultni nemocnice Ostrava

    Ostrava, 708 52

  • Nemocnice Na Homolce

    Prague, 150 30

  • ÚVN Praha

    Prague, 16902

  • Fakultni nemocnice Homoice

    Prague, 500 05

  • Masarykova nemocnice Usti n. Labem

    Ústí nad Labem, 401 13

Other trials in Czechia

France8 sites

  • CHU d'Angers

    Angers, 49933

  • Hopital Pellegrin

    Bordeaux, 33076

  • Hopital neurologique et Neuro-Chirurgical Pierre Wertheimer

    Bron, 69677

  • Hopital Henru Mondor

    Créteil, 94010

  • Hopital General

    Dijon, 21033

  • Hopital de la Timone - CHU de Marseille

    Marseille, 13385

  • Hopital Gui de Chauliac

    Montpellier, 34295

  • Hopital central

    Nancy, 54035

Other trials in France

Belgium7 sites

  • UZ Antwerpen

    Antwerp, 2650

  • ULB Erasme

    Brussels, 1070

  • UZ Brussels

    Brussels, 1090

  • UCL Saint-Luc

    Brussels, 1200

  • UZ Brussels

    Brussels

  • UZ Gent

    Ghent, 9000

  • UZ Gasthuisberg

    Leuven, 3000

Other trials in Belgium

Brazil7 sites

  • Hospital das Clinicas da UFMG

    Belo Horizonte, 30110-934

  • Hospital de Clinicas da Universidade Federal do Parana

    Curitiba, 80060-900

  • Clinica de Neurologia de

    Joinville, 89202-000

  • Hospital de Clínicas de Niteroí

    Niteroí, 24020-090

  • Hospital Moinhos de Vento

    Porto Alegre, 90035-001

  • Hospital Santa Marcelina

    São Paulo, 08270-070

  • Santa Case de Misericordia de Sobral

    Sobral, 62010-550

Other trials in Brazil

Australia5 sites

  • Royal Brisbane & Women's Hosptal

    Brisbane, QLD 4029

  • Royal Prince Alfred Hosptial

    Camperdown, NSW 2050

  • Monash Medical Centre

    Clayton, VIC 3168

  • Gold Coast Hospital

    Southport, Queensland, 4215

  • Princess Alexandra Hospital

    Woolloongabba, QLD 4102

Other trials in Australia

Chile5 sites

  • Hospital Regional de Concepción

    Concepción, 4070038

  • Institute de Neurocirugia

    Santiago, 7500691

  • Hospital Clinico Pontificia Universidad Católica de Chile

    Santiago, 8330024

  • Clinica Davila

    Santiago, 8431657

  • Hospital Carlos Van Buren

    Valparaíso, 2352499

Other trials in Chile

Spain5 sites

  • Hospital Vali d' Hebron

    Barcelona, 08035

  • Hospital Universitari de Bellvitge

    Barcelona, 08907

  • Complejo Hospotalario Virgen de las Nieves-Hospital de Rehabilitacion y Traumatologia

    Granada, 18012

  • Hospital Universitario 12 se Octubre

    Madrid, 28041

  • Hospital de Son Dureta

    Palma de Mallorca, 07014

Other trials in Spain

Austria4 sites

  • Landeskrankenhaus und Medizinische Universitat

    Graz, A-8036

  • Medizinsche Universitat Innsbruck

    Innsbruck, 6020

  • University Fur Neurochirurgie, SALK, Christian Doppler Hospital

    Salzburg, 5020

  • AKH University of Vienna, Medical Univ. Of Neurosurgery

    Vienna, 1090

Other trials in Austria

Italy4 sites

  • Osepedale Maggiore Bellaria

    Bologna, 40139

  • Azienda Ospedaliera di Careggi

    Florence, 50141

  • Azienda Osepedaliera San Giovanni - Addolorata

    Rome, 184

  • Ospedale Maggiore

    Verona, 37126

Other trials in Italy

Switzerland4 sites

  • Kantonsspital Aarau

    Aarau, 5001

  • Universitatsklinik Bern

    Bern, 3010

  • Geneva University Hospital

    Geneva, 1211

  • Universitatsspital Zurich

    Zurich, 8091

Other trials in Switzerland

Argentina3 sites

  • Hospital Aleman

    Buenos Aires, C1118AAT

  • Clinica De Sol

    Buenos Aires, C1425DQI

  • ENERI

    Buenos Aires, C1426ENF

Other trials in Argentina

Denmark3 sites

  • The Neuroscience Center, Copenhagen University Hospital

    Copenhagen, 2100

  • Glostrup Hospital

    Glostrup Municipality, 2600

  • Odense University Hospital

    Odense, DK 5000

Other trials in Denmark

Hungary3 sites

  • Borsod-Abauj-Zemplen County Hospital and University Teaching Hospital

    Miskolc, Borsod-Abauj Zemplen county

  • University of Pecs, Faculty of Medicine Neurosurgery Clinic

    Pécs, 7623

  • University of Szeged, Faculty of Medicine

    Pécs

Other trials in Hungary

India3 sites

  • Post Graduate Institute of Medical Education and Research

    Chandigarh, 160012

  • CARE Hospital

    Hyderabad, 5-4-199

  • King Edward Memorial Hospital

    Pune, 411011

Other trials in India

Israel3 sites

  • Rambam Medical Centre

    Haifa, 31096

  • Hadassah Universtity Medical Center

    Jerusalem, 91120

  • Sheba Medical Centre

    Tel HaShomer, 52621

Other trials in Israel

Norway3 sites

  • Haukeland University Hospital, Helse Bergen HF

    Bergen, 5021

  • Ulleval Univ Hosp

    Oslo, 0407

  • Universitetssykehuset Nord-Norge

    Tromsø, N9038

Other trials in Norway

Sweden3 sites

  • Sahlgrenska University Hospital

    Gothenburg, 41345

  • Linkoping University Hospital

    Linköping, 58185

  • Lund University Hospital

    Lund, 22185

Other trials in Sweden

Finland2 sites

  • Helsinki University Central Hospital

    Helsinki, Fin-00029 HUS

  • Tampere University Central Hospital (TAYS)

    Tampere, 33520

Other trials in Finland

Hong Kong2 sites

  • Queen Mary Hospital

    Hong Kong

  • Prince od Wales Hospital

    Shatin

Other trials in Hong Kong

Mexico2 sites

  • Instituto Nacional de Neurologia y Neurocirugia

    Mexico City, 14269

  • Hospital Universitario "Dr. Jose Eleuterio Gonzalez" Universidad Autonoma de Nuevo Leon

    Monterrey, 64460

Other trials in Mexico

Poland2 sites

  • Szpital Akademii Medycznej w Gdansku

    Gdansk, 80-952

  • Samodzielny Publiczny Centralny Szpital Kliniczy w Warszawie

    Warsaw, 02-097

Other trials in Poland

Singapore2 sites

  • National University Hospital

    Singapore, 119074

  • National Neuroscience Institute

    Singapore, 308433

Other trials in Singapore

Slovenia2 sites

  • University Clinical Centre Ljubljana

    Ljubljana, 1525

  • General Hospital Maribor

    Maribor, 2000

Other trials in Slovenia

Taiwan2 sites

  • National Taiwan University Hospital

    Taipei, 100

  • Taipei Veterans General Hospital

    Taipei, 112

Other trials in Taiwan

Netherlands1 site

  • Elisabeth Ziekenhuis

    Tilburg

Other trials in Netherlands

About this study

Official title: A Prospective, Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Assess the Efficacy and Safety of Clazosentan in Reducing Vasospasm-related Morbidity and All-cause Mortality in Adult Patients With Aneurysmal Subarachnoid Hemorrhage Treated by Endovascular Coiling.

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:

Read more
  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.

Being tested
Clazosentan 5 m/h, Clazosentan 15 mg/h, Placebo
Keywords
Subarachnoid, Aneurysmal, surgical clipping, PIVLAZ, vasospasm, cerebral vasospasm, clazosentan, Actelion, Hemorrhage
Medical subject headings
Subarachnoid Hemorrhage, Vasospasm, Intracranial, Hemorrhage

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Clazosentan 5 m/hDrug

    Also called ACT-108475 (AXV-034343)

    Continuous intravenous infusion of clazosentan (5 mg/h)

  • Clazosentan 15 mg/hDrug

    Also called ACT-108475 (AXV-034343)

    Continuous intravenous infusion of clazosentan clazosentan (15 mg/h)

  • PlaceboDrug

    Continuous intravenous infusion of placebo-matching clazosentan

Study groups in NCT00940095
Study groupRoleWhat they receive
Clazosentan 5 mg/hExperimentalContinuous 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
Receives: Drug: Clazosentan 5 m/h
Clazosentan 15 mg/hExperimentalContinuous 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
Receives: Drug: Clazosentan 15 mg/h
PlaceboPlacebo comparatorContinuous 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
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cerebral vasospasm-related morbidity and mortality of all-causes as defined by the protocol

    Measured: Within 6 weeks post-aSAH

Secondary outcomes (1)

  1. Glasgow Outcome Scale Extended (GOSE) at Week 12 post-aSAH, dichotomized into good (score > 4) and poor (score ≤ 4) outcome.

    Measured: Week 12 post-aSAH

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jul 2009 (estimated)
  2. Study start1 Jul 2009
  3. Primary completion1 Oct 2010
  4. Study completion1 Jan 2011

Why it stopped: Lack of efficacy data from the Phase 3 clinical study (AC-054-301; CONSCIOUS-2)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
577 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00940095
Sponsor's protocol ID
AC-054-302
Acronym
CONSCIOUS-3
Status last verified
Jul 2018
First submitted
13 Jul 2009
Last updated
9 Jul 2018
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 22403047

  • 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.

    PubMed 31394993

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Clazosentan 5 m/h and Clazosentan 15 mg/h in people with Aneurysmal Subarachnoid Hemorrhage, run by Idorsia Pharmaceuticals Ltd. at 145 sites in 28 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 9 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 145 sites in United States, Germany, Canada, Czechia, France and 23 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Lack of efficacy data from the Phase 3 clinical study (AC-054-301; CONSCIOUS-2)). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cerebral vasospasm-related morbidity and mortality of all-causes as defined by the protocol (time frame: Within 6 weeks post-aSAH). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00940095, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2018.

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