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 (REACT)
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|ClinicalTrials.gov Identifier: NCT03585270|
Recruitment Status : Active, not recruiting
First Posted : July 12, 2018
Last Update Posted : June 21, 2022
|Condition or disease||Intervention/treatment||Phase|
|Aneurysmal Subarachnoid Hemorrhage||Drug: Clazosentan Drug: Placebo||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||409 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Masking Description:||This study will be performed in a double-blind fashion. The investigator, study personnel, subjects, clinical research associates (CRAs), sponsor personnel, and vendor / Contract Research Organization (CRO) personnel involved in the conduct of the study will remain blinded to the study treatment received by the subjects during the double-blind treatment period until study closure|
|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)|
|Actual Study Start Date :||December 15, 2018|
|Actual Primary Completion Date :||June 13, 2022|
|Estimated Study Completion Date :||December 28, 2022|
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).
Clazosentan will be administered as a continuous intravenous infusion at the dose of 15 mg/hour for up to 14 days.
Other Name: ACT-108475
Placebo Comparator: Placebo
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).
Placebo will be administered at the same infusion rate as clazosentan for up to 14 days.
- 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 ]Clinical deterioration due to DCI is defined as a worsening of at least 2 points compared to the reference score, on the mGCS or the aNIHSS, lasting for at least 2 hours, which cannot be entirely attributed to causes other than cerebral vasospasm. It is centrally adjudicated by the CEC based on a written charter and review of clinical data, case narratives, angiograms and CT scans.
- Occurrence of clinically relevant cerebral infarction at Day 16 post-study drug initiation [ Time Frame: At Day 16 post study drug initiation ]
A clinical relevant cerebral infarction is defined as: all-cause cerebral infraction ≥ 5 cm3 or cerebral infarction < 5 cm3 in subjects with clinical deterioration due to delayed cerebral ischemia (DCI).
Cerebral infarction refers to new or worsened infarcts and is determined by central radiology review comparing the total volume of infarcts on the computed tomography (CT) scan performed 16 days after study drug initiation with the CT performed just prior to randomization.
- Long-term clinical outcome assessed by the modified Rankin Scale (mRS) at Week 12 post-aSAH, dichotomized into poor outcome (score ≥ 3) and good outcome (score < 3) [ Time Frame: At Week 12 post-aSAH ]
- Long-term clinical outcome assessed by the Glasgow Outcome Scale Extended (GOSE) at Week 12 post-aSAH, dichotomized as follows: poor outcome (score ≤ 4) and good outcome (score > 4) [ Time Frame: At Week 12 post-aSAH ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03585270
|Study Director:||Clinical Trials||Idorsia Pharmaceuticals Ltd.|