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Endothelin Receptor Antagonist

Clazosentan for Brain Aneurysm (REACT Trial)

Phase 3
Waitlist Available
Research Sponsored by Idorsia Pharmaceuticals Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Males and females aged 18 to 70 years (inclusive, at hospital admission)
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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at day 16 post study drug initiation
Awards & highlights

REACT Trial Summary

This trial will compare the effects of adding clazosentan to normal medical care for preventing complications related to cerebral vasospasm after brain aneurysm surgery.

Eligible Conditions
  • Brain Aneurysm

REACT Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

REACT Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at day 16 post study drug initiation
This trial's timeline: 3 weeks for screening, Varies for treatment, and at day 16 post study drug initiation for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Occurrence of Clinical Deterioration Due to Delayed Cerebral Ischemia (DCI) From Study Drug Initiation up to 14 Days Post-study Drug Initiation
Secondary outcome measures
Long-term Clinical Outcome Assessed by the Glasgow Outcome Scale Extended (GOSE) at Week 12 Post-aSAH
Long-term Clinical Outcome Assessed by the Modified Rankin Scale (mRS) at Week 12 Post-aneurysmal Subarachnoid Hemorrhage (aSAH)
Occurrence of Clinically Relevant Cerebral Infarction at Day 16 Post-study Drug Initiation
Other outcome measures
Occurrence of Clinical Deterioration Due to Delayed Cerebral Ischemia (DCI) From Study Drug Initiation up to 14 Days Post-study Drug Initiation (Safety Analysis Set)
Occurrence of Clinical Deterioration Due to Delayed Cerebral Ischemia (DCI) From Study Drug Initiation up to 14 Days Post-study Drug Initiation Based on Neurological Scales and Death
Occurrence of Clinical Deterioration Due to Delayed Cerebral Ischemia (DCI) From Study Drug Initiation up to 14 Days Post-study Drug Initiation Including Rescue Therapy for Non-relevant Vasospasm

Side effects data

From 2022 Phase 3 trial • 409 Patients • NCT03585270
20%
Pyrexia
16%
Hyponatraemia
15%
Constipation
15%
Headache
12%
Gamma-glutamyltransferase increased
12%
Hypokalaemia
12%
Urinary tract infection
11%
Cerebral vasoconstriction
9%
Hypotension
8%
Nausea
8%
Vomiting
7%
Pleural effusion
7%
Alanine aminotransferase increased
7%
Insomnia
6%
Pneumonia
6%
Intracranial pressure increased
6%
Anaemia
6%
Aspartate aminotransferase increased
6%
Pulmonary oedema
5%
Hypertension
3%
Back pain
3%
Polyuria
2%
Brain oedema
2%
Cerebral infarction
1%
Hydrocephalus
1%
Septic shock
1%
Brain death
1%
Acute respiratory distress syndrome
1%
Hypoxia
1%
Neurological decompensation
1%
Aphasia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Clazosentan
Placebo

REACT Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: ClazosentanExperimental Treatment1 Intervention
Participants 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).
Group II: PlaceboPlacebo Group1 Intervention
Participants 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).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Clazosentan
2007
Completed Phase 3
~1650

Find a Location

Who is running the clinical trial?

Idorsia Pharmaceuticals Ltd.Lead Sponsor
118 Previous Clinical Trials
32,048 Total Patients Enrolled
Clinical TrialsStudy DirectorIdorsia Pharmaceuticals Ltd.
2,200 Previous Clinical Trials
888,113 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research study have an age limit?

"In order to take part in this experiment, potential patients must be aged 18-70. There are 58 other trials for minors and 310 for senior citizens."

Answered by AI

Are investigators looking for more participants for this clinical trial?

"This specific study is no longer looking for participants. Although, it's worth noting that there are presently 389 trials actively enrolling patients with hemorrhage and 1 Clazosentan trial searching for candidates."

Answered by AI

In how many different medical clinics is this medical study being run today?

"To limit participant burden, it is ideal to select a clinical trial site location that is nearest to you. There are 17 sites running this study currently, located in cities such as Saskatoon, New york and Columbus among other places."

Answered by AI

What sort of risks are associated with Clazosentan?

"Clazosentan is estimated to be a safe medication, as it has undergone multiple rounds of testing with positive results."

Answered by AI

How do I know if I am able to join this particular research study?

"This clinical trial is accepting 409 participants with hemorrhage aged 18 and 70. Most notable, candidates should meet the following criteria: The recruitment into the early treatment group, i.e. subjects 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"

Answered by AI

Could you tell me if Clazosentan has been looked into before?

"Currently, 1 clinical trial is still active and researching Clazosentan. This study is in Phase 3 out of a total 4 phases. Most of the research for Clazosentan takes place in Badalona, but there are also 110 other locations running similar trials."

Answered by AI

Is this a new or existing study?

"Idorsia Pharmaceuticals Ltd. has been sponsoring research for Clazosentan since 2018, with the first trial involving 409 patients. After Phase 3 approval was received in 2018, there is now a single active study being conducted by Idorsia Pharmaceuticals Ltd.."

Answered by AI

How many willing test subjects are being enrolled in this experiment?

"This particular trial is no longer actively recruiting patients. However, when this study was first posted on December 15th 2018, it did continue to recruit until June 16th 2022. There are also other trials happening related to hemorrhage and Clazosentan with 389 and 1 clinical trials respectively."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
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
2019. "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". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03585270.
~66 spots leftby Apr 2025
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