Date: 2018-06-18
Type of
information: Initiation of the trial
phase: 3
Announcement: initiation of the trial
Company: Idorsia (Switzerland)
Product: clazosentan
Action
mechanism: endothelin receptor antagonist
Disease: prevention of clinical deterioration due to vasospasm-related delayed cerebral ischemia in patients following an aneurysmal subarachnoid hemorrhage
Therapeutic
area: Cerebrovascular diseases
Country:
Trial
details:
- REACT is 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 vasospasm-related delayed cerebral ischemia, in adult patients with aSAH. Approximately 400 patients, regardless of whether their hemorrhage has been treated with surgical clipping or endovascular coiling are expected to be enrolled. Patients will be enrolled from 100 trial sites across 15 countries who will be randomized to either 15 mg/hr clazosentan or placebo for a treatment period of up to 14 days. The study is expected to run for around 27 months. (NCT03585270)
Latest
news:
- • On June 18, 2018, Idorsia announced that it is initiating a Phase 3 study, REACT, to investigate the efficacy and safety of clazosentan for the prevention of clinical deterioration due to vasospasm-related delayed cerebral ischemia in patients following an aneurysmal subarachnoid hemorrhage.
- Aneurysmal subarachnoid hemorrhage (aSAH) is a sudden life-threatening bleeding occurring in the subarachnoid space. It is caused by the rupture of an aneurysm - a weak, bulging spot on the wall of a cerebral artery. Emergency surgical repair (endovascular coiling or microsurgical clipping) is required to stop the hemorrhage. The bleeding and the release of a vasoconstrictor, endothelin, by the neighboring vascular endothelium, causes many patients to experience vasospasm (constriction of arteries in the brain). This diminishes blood flow to the brain and as a consequence, about one third of patients experience worsening of their neurological condition. Patients with thick and diffuse blot clots are at a significantly higher risk of experiencing cerebral vasospasm. Today, patients with vasospasm are typically treated with hemodynamic therapy, or more invasive neurovascular intervention such as balloon angioplasty or intra-arterial administration of vasodilators.
- REACT will enroll aSAH patients identified as being at high-risk of developing delayed ischemic neurological deficit because of high volume of their hemorrhage, as assessed by CT scan on hospital admission. Patients experiencing asymptomatic moderate to severe cerebral vasospasm within 14 days of securing the aneurysm may also be included.
Is
general: Yes
