Clazosentan in Aneurysmal Subarachnoid Hemorrhage (NCT00940095) | Clinical Trial Compass
TerminatedPhase 3
Clazosentan in Aneurysmal Subarachnoid Hemorrhage
Stopped: Lack of efficacy data from the Phase 3 clinical study (AC-054-301; CONSCIOUS-2)
United States577 participantsStarted 2009-07-01
Plain-language summary
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.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Males and females aged 18 to 75 years (inclusive).
✓. Patients with a ruptured saccular aneurysm, confirmed by angiography (digital subtraction angiography \[DSA\] or computed tomography angiography \[CTA\], investigator's assessment), and which has been successfully\* secured by endovascular coiling. The 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 endovascular coiling procedure, and which does not worsen to grade V post-procedure (based on regular Glasgow Coma Scale \[GCS\])
✓. Patients with any thick clot (short axis \> or = 4 mm) on baseline CT scan (investigator's assessment).
✓. 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.
✓. Written informed consent to participate in the study must be obtained from the patient or a legal representative prior to initiation of any study-mandated procedure and randomization.
Exclusion criteria
What they're measuring
1
Cerebral vasospasm-related morbidity and mortality of all-causes as defined by the protocol
. Subarachnoid hemorrhage (SAH) due to causes other than saccular aneurysm.
✕. Giant aneurysms (height or width \> or = 25 mm).
✕. Intraventricular or intracerebral blood, in absence of subarachnoid blood, or or with only a thin clot (short axis \< 4 mm)
✕. Cerebral vasospasm on angiography (investigator's assessment) prior to endovascular coiling (intraprocedural cerebral vasospasm is not an exclusion criterion).
✕. A major complication during the endovascular coiling procedure, such as massive intracranial bleeding, intracranial thromboembolism, coil migration, aneurysm perforation or rupture, arterial dissection, 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 (e.g., hemiplegia or aphasia lasting \> or = 12 hours post-aneurysm coiling)\*.
✕. Current ruptured aneurysm previously secured (successfully or not) by clipping.
✕. Coiling material used, which has not been approved by local health authorities.
✕. Use of liquid embolism aneurysmal treatment or flow diverting device.