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

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.

Timeline

Start

2019-02-03

Primary completion

2022-06-13

Completion

2022-11-18

Outcome

Missed primary endpoint

paper Clazosentan administered for up to 14 days at 15 mg/hour had no significant effect on the occurrence of clinical deterioration due to DCI. PMID 39126720 ↗

registry analysis (superiority test); Clazosentan vs Placebo; p = 0.7338; Relative Risk Reduction 0.072 (95% CI -0.426 to 0.396); Cochran-Mantel-Haenszel NCT03585270 ↗

release “Clazosentan – Global Phase 3 study, REACT, did not meet primary endpoint” idorsia.com ↗

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.
• 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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Clazosentan	Small molecule	15 mg	Intravenous

Indications