Clazosentan in Aneurysmal Subarachnoid Hemorrhage "CONSCIOUS-3"

Terminated

Phase 3 Results N/A

Trial Description

The aim of this study is to demonstrate that clazosentan, administered as a continuous intravenous infusion at either 5 mg/h or 15 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 endovascular coiling.
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. Administration of a valid rescue therapy in the presence of confirmed cerebral vasospasm on angiography (DSA or CTA).
An independent Critical Events Committee (CEC) will adjudicate whether or not patients meet the primary endpoint and its individual morbidity components.

Trial Stopped: Lack of efficacy data from the Phase 3 clinical study (AC-054-301; CONSCIOUS-2)

Conditions

Interventions

  • Clazosentan (Pivlaz)Drug
    Other Names: AXV-034343
    Intervention Desc: 15 mg/h
    ARM 1: Kind: Experimental
    Label: Clazosentan, 5mg/h
    ARM 2: Kind: Experimental
    Label: Clazosentan 15mg/h
  • Placebo Drug
    Intervention Desc: Matching Placebo
    ARM 1: Kind: Experimental
    Label: Placebo

Trial Design

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

Patient Involvement

Patients will be randomized to receive either clazosentan, administered as a continuous intravenous infusion at either 5 mg/h or 15 mg/h until Day 14 post aneurysmal subarachnoid hemorrhage (aSAH) or a placebo. Patients will be assessed using Glasgow Outcome Scale Extended (GOSE) at Week 12 post-aSAH, dichotomized into good (score > 4) and poor (score ? 4) outcome.

Outcomes

Type Measure Time Frame Safety Issue
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 Yes
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 Yes

Sponsors