Clazosentan in Reducing Vasospasm-related Morbidity and All-cause Mortality in Adult Patients With Aneurysmal Subarachnoid Hemorrhage Treated by Surgical Clipping "CONSCIOUS-2"

Completed

Phase 3 Results N/A

Trial Description

The aim of this study is to demonstrate that clazosentan, administered as a continuous intravenous infusion at 5 mg/h until Day 14 post aneurysmal subarachnoid hemorrhage (aSAH), reduces the incidence of cerebral vasospasm -related morbidity and all-cause mortality within 6 weeks post-aSAH treated by surgical clipping. The primary endpoint of the study is the occurrence of cerebral vasospasm-related morbidity, and mortality of all-causes within 6 weeks post-aSAH, defined by at least one of the following:
1. Death (all causes).
2. New cerebral infarct(s) due to cerebral vasospasm as either the primary or relevant contributing cause, or not adjudicated to be entirely due to causes other than vasospasm.
3. Delayed ischemic neurological deficit (DIND) due to cerebral vasospasm as either the primary or relevant contributing cause, or not adjudicated to be entirely due to causes other than vasospasm.
4. Neurological signs or symptoms (depending on state of consciousness), in the presence of confirmed cerebral vasospasm on angiography (DSA or CTA), leading to the administration of a valid rescue therapy.
An independent Critical Events Committee (CEC) will adjudicate whether or not patients meet the primary endpoint and its individual morbidity components.

Conditions

Interventions

  • Clazosentan (Pivlaz)Drug
    Other Names: AXV-034343
    Intervention Desc: Intravenous clazosentan administered by continuous infusion at 5 mg/h for the duration of the treatment
    ARM 1: Kind: Experimental
    Label: 1 A
    Description: clazosentan
  • Placebo Drug
    Intervention Desc: Placebo administered by continuous infusion at 5 mg/h for the duration of the treatment.
    ARM 1: Kind: Experimental
    Label: 2 B
    Description: placebo

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Pharmacokinetics Study
  • Intervention: Parallel Assignment

Patient Involvement

Intravenous clazosentan administered by continuous infusion at 5 mg/h for the duration of the treatment Placebo administered by continuous infusion at 5 mg/h for the duration of the treatment.

Outcomes

Type Measure Time Frame Safety Issue
Primary Cerebral vasospasm-related morbidity and mortality of all-causes as defined by the protocol.
Secondary Glasgow Outcome Scale Extended (GOSE) at Week 12 post-aSAH, dichotomized into good (score > 4) and poor (score ? 4) outcome.
Primary Cerebral vasospasm-related morbidity and mortality of all-causes as defined by the protocol Within 6 weeks post-aSAH No
Secondary Glasgow Outcome Scale Extended (GOSE) at Week 12 post-aSAH, dichotomized into good (score > 4) and poor (score ≤ 4) outcome. Week 12 post-aSAH No

Sponsors