CONSCIOUS-2
Clazosentan in Reducing Vasospasm-Related Morbidity and All-Cause Mortality in Adult Patients With Aneurysmal Subarachnoid Hemorrhage Treated by Surgical Clipping
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Purpose:
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.
Interventions:
Clazosentan
Intravenous endothelin receptor antagonist.
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Location(s):
Australia; Austria; Belgium; Canada;
China; Croatia;
Czech Republic; Denmark; Finland;
France; Germany;
Hong Kong; India;
Italy; New Zealand;
Norway; Poland; Serbia and Montenegro;
Singapore; Slovenia;
Spain; Sweden; Switzerland; Turkey; United States.
Year Started:
2007
Design:
Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study, Interventional.
Inclusion Criteria
Patients with a ruptured saccular aneurysm, confirmed by angiography (digital subtraction angiography [DSA] or computed tomography angiography [CTA]), and which has been successfully secured by surgical clipping; Time of aneurysm rupture must be known or possible to estimate with a reasonable degree of certainty; World Federation of Neurological Surgeons (WFNS) grade I-IV measured prior to the clipping procedure, and which does not worsen to grade V post-procedure (based on regular Glasgow Coma Scale [GCS])*;
patients with any diffuse clot (long axis > or = 20 mm, or any clot present across both hemispheres) on baseline CT scan; women of childbearing potential must have a negative serum pregnancy test and must use a reliable method of contraception during the 12 weeks following study drug discontinuation; patients must be evaluable for WFNS grade prior to the clipping procedure; patients who cannot be assessed for WFNS post-procedure due to a requirement for uninterrupted sedation may be included in the study provided that a CT scan is performed at 12 hours post-procedure, but prior to randomization, ruling out any large procedure-related infarct.
Exclusion Criteria
Patients with subarachnoid hemorrhage (SAH) due to causes other than a saccular aneurysm; patients with intraventricular or intracerebral blood, in the absence of subarachnoid blood, or with only a local clot; presence of cerebral vasospasm seen on angiography prior to the clipping procedure; patients who experienced a major complication during the clipping procedure, such as massive bleeding, major arterial occlusion, a large territorial cerebral infarct defined as involving > 1/3 of a vascular territory, or a new major neurological deficit post-procedure; patients for whom study drug cannot be started within 56 hours after the aneurysm rupture; patients who have had their aneurysm secured by coiling only; patients for whom it is known that certain follow-up, protocol-mandated imaging assessments will not be feasible; patients with hypotension that is refractory to treatment; patients with aspiration pneumonia;
patients with pulmonary edema or severe cardiac failure requiring inotropic support; any severe or unstable concomitant condition or disease; significant kidney and/or liver disease; patients receiving i.v. nimodipine, i.v. nicardipine, or fasudil hydrochloride, must have these drugs discontinued at least 4 hours prior to initiation of the study treatment; patients receiving statins for less than 2 weeks prior to admission must have them discontinued prior to study drug initiation; patients receiving cyclosporin A or other calcineurin inhibitors or patients for whom it is known at the time of randomization that these medications will be started during the study drug infusion period; patients who have received an investigational product within 28 days prior to randomization or those who have already participated in the current study; patients unlikely to comply with the protocol; known hypersensitivity to other endothelin receptor antagonists; patients with current alcohol or drug abuse or dependence.
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.
Primary Outcome:
Cerebral vasospasm-related morbidity and mortality of all-causes as defined by the protocol.
Secondary Outcome:
Glasgow Outcome Scale Extended (GOSE) at Week 12 post-aSAH, dichotomized into good (score > 4) and poor (score ≤ 4) outcome.
Source of Information:
ClinicalTrials.gov
Study Id : AC-054-301
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Web Links and Publications:
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This information last updated on: 11/3/2009
Reviewed on: 08/18/2009.
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