Clazosentan in Reducing Vasospasm-related Morbidity and All-cause Mortality in Adult Patients Wit… (NCT00558311) | Clinical Trial Compass
CompletedPhase 3
Clazosentan in Reducing Vasospasm-related Morbidity and All-cause Mortality in Adult Patients With Aneurysmal Subarachnoid Hemorrhage Treated by Surgical Clipping
United States1,157 participantsStarted 2007-12-14
Plain-language summary
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.
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 \[CTA\]), and which has been successfully secured by surgical clipping. 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 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.
✓. 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
. Patients with subarachnoid hemorrhage (SAH) due to causes other than a saccular aneurysm (e.g., trauma or rupture of fusiform or mycotic aneurysms).
✕. 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 (e.g., hemiplegia or aphasia lasting \> or = 12 hours post-aneurysm clipping).\*
✕. 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, at the time of screening, that certain follow-up, protocol-mandated imaging assessments will not be feasible.
✕. Patients with hypotension (systolic blood pressure (SBP)\< or = 90 mmHg) that is refractory to treatment.