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Aneurysmal Subarachnoid HemorrhagePhase 3REACTNCT03585270

Clinical Research Study With Clazosentan to Evaluate Its Effects on Preventing Complications Due to the Narrowing of the Blood Vessels (Vasospasm) in the Brain, Caused by Bleeding Onto the Surface of the Brain

A Phase 3 study testing Clazosentan in people with Aneurysmal Subarachnoid Hemorrhage, run by Idorsia Pharmaceuticals Ltd. at 80 sites in 15 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This study will evaluate if clazosentan (on top of normal routine medical care) can reduce the risk of developing complications related to cerebral vasospasm and permanent brain damage as compared to normal routine medical care alone. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Aneurysmal Subarachnoid Hemorrhage
What is being tested?
Clazosentan
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
409 participants
Where
80 sitesin 15 countries
Study dates
3 Feb 2019to 18 Nov 2022
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Written informed consent to participate in the study must be obtained from the subject or proxy/legal representative at any time from hospital admission to prior to initiation of any study-mandated procedure,
  • Males and females aged 18 to 70 years (inclusive, at hospital admission),
  • Participants with a ruptured saccular aneurysm, angiographically confirmed by DSA or CTA, which has been successfully secured within 72 hours of rupture, by surgical clipping or endovascular coiling,
  • WFNS (World Federation of Neurosurgical Societies) grades 1-4 (based on Glasgow Coma Scale [GCS]) assessed after recovery from the aneurysm-securing procedure and after external ventricular drainage for hydrocephalus, if required.
  • Participants must meet the criteria for the high-risk prevention group: Subjects with a "thick and diffuse clot" (thick and diffuse is defined as a thick confluent clot, more than 4 mm in thickness, involving 3 or more basal cisterns) on the hospital admission CT scan, absence of cerebral vasospasm at the time of randomization, and possibility to start study drug in the ICU (or equivalent environment where all protocol assessments can be performed and the Patient Management Guidelines followed), within 96 hours after the time of the aneurysm rupture.
  • The recruitment into the early treatment group, i.e. participants without a thick and diffuse clot on the hospital admission CT scan who develop asymptomatic or minimally symptomatic moderate to severe angiographic vasospasm, within the 14-day period post-aneurysm rupture, and for whom it is possible to start study drug in the ICU (or equivalent environment where all protocol assessments can be performed and the Patient Management Guidelines followed), within 24 hours of this angiographic diagnosis, has been discontinued.
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  • Presence of a cerebral CT scan performed at least 8 hours post aneurysm securing procedure and within 24 hours prior to randomization.
  • Absence of a significant (e.g., symptomatic or large) new or worsened cerebral infarct or re-bleeding of the repaired aneurysm on the post-procedure CT scan.
  • A woman of childbearing potential is eligible only if the pregnancy test performed during the screening period is negative. Agreement must be obtained to take the necessary precautions to avoid pregnancy from hospital discharge until 30 days post-study drug discontinuation. If breastfeeding, agreement must be obtained to refrain for the duration of the treatment with study drug and until 30 days post-study drug discontinuation.
  • Males are eligible for study participation only if they agree to take the necessary precautions to avoid pregnancy in a female partner from hospital discharge until 30 days post-study drug discontinuation.

Who cannot join

  • Aneurysmal subarachnoid hemorrhage (aSAH), aneurysm-securing procedure, vasospasm:
  • Participants with SAH due to causes other than a saccular aneurysm (e.g., trauma or rupture of fusiform or mycotic aneurysms, SAH associated with arterio-venous malformation, vertebral dissections),
  • Significant bleeding post aneurysm-securing procedure (e.g., due to intra-ventricular drain, intra-cerebral hemorrhage, epidural hematoma, vessel dissection or rupture, re-bleeding of the repaired aneurysm), based on investigator judgment,
  • Intra-or peri-aneurysm securing procedure complication requiring non-routine medical or interventional treatment such as administration of an antithrombotic or anti-platelet agent (e.g., abciximab), which is not completely resolved prior to randomization,
  • Intraventricular hemorrhage on the hospital admission CT scan, filling more than 50% of both lateral ventricles and with involvement of the 3rd and 4th ventricles.
  • Intracerebral hemorrhage on the hospital admission CT scan, with an approximate volume of > 50 mL,
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  • Presence of cerebral vasospasm at hospital admission (initial admission or transfer from another hospital) believed to be associated with a prior bleed (i.e., occurring before the bleed for which the subject is currently hospitalized). Vasospasm occurring during the aneurysm securing procedure is not an exclusion criterion,
  • Neurological and functional status:
  • Participants with a new major neurological deficit occurring post aneurysm-securing procedure which is attributable to the procedure and does not improve to pre-procedure status before randomization,
  • Participants with a GCS score of ≤ 9 at the time of randomization and without intracranial pressure (ICP) monitoring,
  • Modified Rankin Score of 3 or higher, prior to the aSAH (i.e., due to a chronic condition),
  • Other clinical considerations:
  • Participants with total bilirubin > 2 times the upper limit of normal, and/or a known diagnosis or clinical suspicion of liver cirrhosis or moderate to severe hepatic impairment,
  • Hypotension (systolic blood pressure [SBP] ≤ 90 mmHg) at time of randomization that is refractory to treatment,
  • Unresolved pulmonary edema or significant pneumonia still present at the time of randomization, or severe hypoxia at the time of randomization in intubated subjects, defined as PaO2/FiO2 ≤ 200,
  • High sustained ICP (> 25 mmHg lasting > 20 minutes) at time of randomization, despite optimal treatment, in subjects with ICP monitoring,
  • Severe cardiac failure requiring inotropic support at the time of random

Trial locations and contacts

80 sites in 15 countries.

80 sites in 15 countries

United States16 sites

  • University of Maryland Medical Systems - Neurosurgery

    Baltimore, Maryland, 21201

  • Boston University School of Medicine / Boston University Medical Center

    Boston, Massachusetts, 02118

  • Beth Israel Deaconess Medical Center Dept of Neurosurgery

    Boston, Massachusetts, 02215

  • University of Illinois - Department of Neurosurgery

    Chicago, Illinois, 60612

  • University Hospitals Case Medical Center - Department of Neurosurgery

    Cleveland, Ohio, 44106

  • The Ohio State University - Wexner Medical Center

    Columbus, Ohio, 43210

  • Penn State Milton S Hershey Medical Center, Neurosurgery

    Hershey, Pennsylvania, 17033

  • Mayo clinic, Dept of Neurosurgery

    Jacksonville, Florida, 32224

  • Northwell Health, Department of Neurosurgery

    Manhasset, New York, 11030

  • Vanderbilt University Medical Center - Department of Neurosurgery

    Nashville, Tennessee, 37232

  • Mt Sinai Hospital

    New York, New York, 10029

  • Columbia University Medical Center Dept. of Neurology - Neurological Intensive Care Unit

    New York, New York, 10032

  • Oklahoma University Health Sciences Center - Department of Neurology

    Oklahoma City, Oklahoma, 73104

  • Oregon Health and Science University

    Portland, Oregon, 97239

  • Virginia Commonwealth University, Department of Neurosurgery

    Richmond, Virginia, 23298

  • Stanford Hospital & Clinics - Stanford School of Medicine Dept. of Neurosurgery

    Stanford, California, 94305

Other trials in United States

Germany13 sites

  • Klinik für Diagnostische Radiologie und Neuroradiologie, Augsburg

    Augsburg, 86156

  • Charite Universitätsmedizin Berlin - Klinik und Poliklinik für Neurochirurgie

    Berlin, 10117

  • Heinrich-Heine Universität Düsseldorf -Klinik für Neurochirugie

    Düsseldorf, 40225

  • University of Erlangen-Nürnberg, Dpt. of Neurosurgery

    Erlangen, 91054

  • University Hospital of Essen, Department of Neurosurgery

    Essen, 45147

  • Universitätsklinik Frankfurt, Klinik und Poliklinik für Neurochirurgie, Dept of neurosurgery

    Frankfurt, 60528

  • Bezirkskrankenhaus Günzburg - Klinik für Neurochirugie

    Günzburg, 89132

  • Asklepios Klinik St. Georg - Neurochirugie

    Hamburg, 20099

  • University Hospital of Hamburg-Eppendorf, Dpt. of Neurosurgery

    Hamburg, 20246

  • Neurochirurgische Universitätklinik des Heidelberg, Dept of Neurosurgery

    Heidelberg, 69120

  • Universitätsklinikum Schleswig Hollstein Lübeck (UKSH) Klinik für Neurochirugie

    Lübeck, 23538

  • University Regensburg, Dpt. of Neurosurgery

    Regensburg, 93053

  • Universitätsklinikum Rostock, Abteilung für Neurochirurgie

    Rostock, 18057

Other trials in Germany

Spain8 sites

  • Hospital Universitario Germans Trias i Pujol - Neurology Department

    Badalona, 08916

  • Hospital Vall d'Hebron Departamento Neuroradiología

    Barcelona, 08035

  • Hospital Clinic Barcelona

    Barcelona, 08036

  • Hospital Universitari de Bellvitge

    L'Hospitalet de Llobregat, 08907

  • University Hospital of Gran Canaria Dr. Negrin

    Las Palmas de Gran Canaria, 35010

  • Hospital Universitario 12 de Octubre, Departamento Neurosurgery Division Neuroradiology

    Madrid, 28041

  • Hospital Universitari son Espases

    Palma de Mallorca, 07014

  • Corporació Sanitària Parc Taulí, Hospital Parc Taulí

    Sabadell, 08208

Other trials in Spain

France7 sites

  • Hôpital neurologique Pierre Wertheimer Service de Reanimation

    Bron, 69006

  • Hôpital Gabriel Montpied, ICU DEPT, Neuro reanimation departement

    Clermont-Ferrand, 63003

  • Hôpital de la Timone 2, Intensive Care Unit SAR 1

    Marseille, 13385

  • Hôpital Nord Laennec - CHU de Nantes

    Nantes, 44093

  • Hospital Lariboisiere Paris

    Paris, 75010

  • Hôpital Pitié-Salpêtrière, Service de neuroréanimation chirurgicale Babinski

    Paris, 75013

  • Univ Hosp Toulouse, University Hospital Purpan Pierre Paul Riquet Hospital

    Toulouse, 31059

Other trials in France

Czechia5 sites

  • Fakultní nemocnice Brno Neurochirurgická klinika

    Brno, 625 00

  • Fakultní nemocnice Ostrava Neurochirurgická klinika

    Ostrava-Poruba, 708 52

  • University Hospital in Pilsen, Department of Neurosurgery

    Pilsen, 304 60

  • Ústřední vojenská nemocnice Praha Neurochirurgická klinika

    Prague, 169 02

  • Masarykova nemocnice v Ústí nad Labem Neurochirurgie

    Ústí nad Labem, 401 13

Other trials in Czechia

Belgium4 sites

  • Hospital Erasme, Service de Soins Intensifs

    Brussels, 1070

  • Hospital - Cliniques Universitaires Saint-Luc, Service de Neurochirurgie

    Brussels, 1200

  • Neurology Department, University Hospital

    Ghent, 9000

  • University Hospital Sart Tilman Liege

    Liège, 4000

Other trials in Belgium

Canada4 sites

  • University of Alberta Hospital Department of Neurological Surgery

    Edmonton, Alberta, T6G 2B7

  • Halifax Infirmary, Nova Scotia Health Authority

    Halifax, Nova Scotia, B3H 3A7

  • Royal University Hospital Department of Neurology

    Saskatoon, Saskatchewan, S7N 0W8

  • Winnipeg Regional Health Authority Health Sciences Centre

    Winnipeg, Manitoba, R3A 1R9

Other trials in Canada

Finland4 sites

  • Helsingin yliopistollinen keskussairaala Neurokirurgian klinikka

    Helsinki, 00260

  • Kuopio University Hospital

    Kuopio, 70210

  • Tampereen yliopistollinen sairaala Neurokirurgian klinika

    Tampere, 33520

  • Turku University Hospital Neurosurgery, T-hospital

    Turku, 20520

Other trials in Finland

Israel4 sites

  • Rambam Healthcare Campus, Neurology Department

    Haifa, 3109601

  • Hadassah Medical Center

    Jerusalem, 9112001

  • Beilinson Hospital, Rabin Medical Center, Department of Neurosurgery

    Petah Tikva, 4941492

  • The Chaim Sheba Medical Centre - Neurosurgery

    Ramat Gan, 5265601

Other trials in Israel

Italy4 sites

  • ASST Monza, Hospital San Gerardo, TERAPIA INTENSIVA Neurochirurgica

    Monza, 20900

  • Azienda Ospedaliera Padova-Università degli Studi di Padova - Istituto di Anestesia e Rianimazione

    Padova, 35128

  • Azienda Ospedaliero Universitaria di Parma, struttura complessa Neurochirurgia

    Parma, 43126

  • Fondazione Policlinico Universitario Agostino Gemelli Università Cattolica del Sacro Cuore, UOS Terapia Intensiva Neurochirurgic

    Rome, 00168

Other trials in Italy

Poland3 sites

  • Uniwersytecki Szpital Kliniczny nr 1 im. Norberta Barlickiego

    Lodz, 90-153

  • Oddział Neurochirurgii i Neurotraumatologii z Pododdziałem Leczenia Chorób Naczyniowych Centralnego Układu Nerwowego

    Poznan, 60-355

  • Katedra i Klinika Neurochirurgii Samodzielny Publiczny Centralny Szpital Kliniczny w Warszawie

    Warsaw, 02-097

Other trials in Poland

Sweden3 sites

  • Sahlgrenska Universitetssjukhuset, Verksamheten för neurokirurgi, Neurosjukvården

    Gothenburg, 41345

  • Linköping Universitetssjukhuset, Neurokirurgiska kliniken

    Linköping, 58185

  • Lunds Universitetssjukhus, Neurokirurgiska avd. NIVA

    Lund, 22185

Other trials in Sweden

Austria2 sites

  • Medizinische Universität Innsbruck; Universitätsklinik für Neurologie und Psychiatrie

    Innsbruck, 6020

  • Kepler Universitätsklinikum, Universitätsklinik für Neurochirurgie

    Linz, A-4020

Other trials in Austria

Hungary2 sites

  • Debreceni Egyetem, Idegsebészet

    Debrecen, 4032

  • Pécsi Tudományegyetem Klinikai Központ, Idegsebészeti Klinika

    Pécs, 7623

Other trials in Hungary

Denmark1 site

  • Odense Universitets Hospital Neurokirurgisk afdelning

    Odense, 5000

Other trials in Denmark

About this study

Official title: A Prospective, Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-group, Phase 3 Study to Assess the Efficacy and Safety of Clazosentan in Preventing Clinical Deterioration Due to Delayed Cerebral Ischemia (DCI), in Adult Subjects With Aneurysmal Subarachnoid Hemorrhage (aSAH)

This study will evaluate if clazosentan (on top of normal routine medical care) can reduce the risk of developing complications related to cerebral vasospasm and permanent brain damage as compared to normal routine medical care alone.

Read the detailed description

When a blood vessel just outside the brain bursts and causes bleeding onto its surface, the space surrounding the brain (the subarachnoid space) fills with blood. This condition is called subarachnoid hemorrhage. The bleeding due to the rupture of a pouch-like structure or a bulge (called an aneurysm) that formed on one of the blood vessels is condition called aneurysmal subarachnoid hemorrhage (aSAH).

In this study, clazosentan is being tested against normal routine medical care to determine if clazosentan can reduce the risk of developing complications related to vasospasm and permanent brain damage.

Participation will last for approximately 6 months from the episode of bleeding. For subjects randomized in the high-risk prevention group, treatment will start within 96 hours following the time of the aneurysm rupture, and be administered where possible, for 14 days. For subjects randomized in the early treatment group, treatment must begin within 24 hours of the time of the angiogram documenting the cerebral vasospasm necessary for entry into the study. Treatment will be administered for a minimum of 6 days and a maximum of 14 days. Recruitment in the early treatment group has been discontinued.

The end-of-study will be conducted as a telephone interview 6 months after the episode of bleeding.

Being tested
Clazosentan, Placebo
Medical subject headings
Subarachnoid Hemorrhage

What participants receive

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

  • ClazosentanDrug

    Also called ACT-108475

    Clazosentan will be administered as a continuous intravenous infusion at the dose of 15 mg/hour for up to 14 days.

  • PlaceboDrug

    Placebo will be administered at the same infusion rate as clazosentan for up to 14 days.

Study groups in NCT03585270
Study groupRoleWhat they receive
ClazosentanExperimentalParticipants will receive clazosentan for up to 14 days, followed by a safety follow-up period of 24 hours, and an extended follow-up period to the end-of-study visit at Week 24 post aneurysmal subarachnoid hemorrhage (aSAH).
Receives: Drug: Clazosentan
PlaceboPlacebo comparatorParticipants will receive clazosentan matching-placebo for up to 14 days, followed by a safety follow-up period of 24 hours, and an extended follow-up period to the end-of-study visit at Week 24 post aneurysmal subarachnoid hemorrhage (aSAH).
Receives: Drug: Placebo

What is being measured

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

  1. Occurrence of Clinical Deterioration Due to Delayed Cerebral Ischemia (DCI) From Study Drug Initiation up to 14 Days Post-study Drug Initiation

    Clinical deterioration due to delayed cerebral ischemia is defined as a worsening of at least 2 points compared to the reference score, on the modified Glasgow Coma Scale or the abbreviated National Institutes of Health Stroke Scale (aNIHSS), lasting for at least 2 hours, which cannot be entirely attributed to causes other than cerebral vasospasm. It is centrally adjudicated by the Clinical Event Committee (CEC) based on a written charter and review of clinical data, case narratives, angiograms and Computed Tomography scans.

    Measured: Up to 14 days post-study drug initiation

Secondary outcomes (3)

  1. Occurrence of Clinically Relevant Cerebral Infarction at Day 16 Post-study Drug Initiation

    A clinical relevant cerebral infarction was defined as: all-cause cerebral infraction greater than or equal to 5 cm^3 or cerebral infarction less than 5 cm^3 in participants with clinical deterioration due to delayed cerebral ischemia.

    Cerebral infarction refers to new or worsened infarcts and was determined by a central radiology review comparing the total volume of infarcts on the computed tomography (CT) scan performed 16 days after study drug initiation with the total volume on the CT scan performed just prior to randomization.

    Measured: At Day 16 post study drug initiation

  2. Long-term Clinical Outcome Assessed by the Modified Rankin Scale (mRS) at Week 12 Post-aneurysmal Subarachnoid Hemorrhage (aSAH)

    The modified Rankin Scale (mRS) was used to measure the degree of disability in participants who had a ruptured saccular aneurysm and were at a high risk of developing a delayed cerebral infarction (DCI). The mRS is scored by the physician. The mRS scores ranged from 0 (no symptoms) to 6 (dead). The mRS score was dichotomized into poor outcome (score greater and equal to 3) and good outcome (score less than 3).

    Measured: At Week 12 post-aneurysmal subarachnoid hemorrhage (aSAH)

  3. Long-term Clinical Outcome Assessed by the Glasgow Outcome Scale Extended (GOSE) at Week 12 Post-aSAH

    The Glasgow Outcome Scale - Extended (GOSE) is a scale scored by the physician. The GOSE scores range from 1 (dead) to 8 (upper good recovery).

    The long-term clinical outcome assessed by the GOSE was dichotomized into poor outcome (score ≤ 4) and good outcome (score > 4)

    Measured: At Week 12 post-aneurysmal subarachnoid hemorrhage (aSAH)

Timeline

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

  1. First posted12 Jul 2018
  2. Study start3 Feb 2019
  3. Primary completion13 Jun 2022
  4. Study completion18 Nov 2022

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
409 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03585270
Sponsor's protocol ID
ID-054-304
Other IDs
2018-000241-39, 2018
Acronym
REACT
Status last verified
Dec 2023
First submitted
29 Jun 2018
Last updated
10 Jan 2024
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Mayer SA, Bruder N, Citerio G, Defreyne L, Dubois C, Gupta R, Higashida R, Marr A, Nguyen TN, Roux S, Smrcka M, Torne RT, Aldrich EF; on behalf of the REACT investigators. REACT: a randomized trial to assess the efficacy and safety of clazosentan for preventing clinical deterioration due to delayed cerebral ischemia after aneurysmal subarachnoid hemorrhage. J Neurosurg. 2024 Aug 9;142(1):98-109. doi: 10.3171/2024.4.JNS232191. Print 2025 Jan 1.

    PubMed 39126720

  • Bruder N, Higashida R, Santin-Janin H, Dubois C, Aldrich EF, Marr A, Roux S, Mayer SA. The REACT study: design of a randomized phase 3 trial to assess the efficacy and safety of clazosentan for preventing deterioration due to delayed cerebral ischemia after aneurysmal subarachnoid hemorrhage. BMC Neurol. 2022 Dec 20;22(1):492. doi: 10.1186/s12883-022-03002-8.

    PubMed 36539711

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Clazosentan in people with Aneurysmal Subarachnoid Hemorrhage, run by Idorsia Pharmaceuticals Ltd. at 80 sites in 15 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 10 inclusion and 17 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: finished, as of the sponsor's last update on 10 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 80 sites in United States, Germany, Spain, France, Czechia and 10 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?

Yes. Results are posted in the registry (first posted 10 Jan 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Occurrence of Clinical Deterioration Due to Delayed Cerebral Ischemia (DCI) From Study Drug Initiation up to 14 Days Post-study Drug Initiation (time frame: Up to 14 days post-study drug initiation). 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 NCT03585270, 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 10 Jan 2024.

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