Prevention of ischaemic complications related to vasospasm in patients with aneurysmal subarachnoid haemorrhage
Conditions
Sponsors
Actelion Pharmaceuticals Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female patients aged 18 to 70 years (inclusive). 2. Patients with a ruptured saccular aneurysm that has been confirmed by digital subtraction angiography (DSA) and for which clipping or coiling (endovascular obliteration) is possible. 3. Patients with a diffuse or localized thick subarachnoid clot on baseline CT scan. Measurements defining clot thickness and extension are as follows: Diffuse: Clot with long axis >= 20 mm, or any clot if present in both hemispheres Localized: Clot with long axis = 4 mm Thin: Clot with short axis =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Patients with SAH due to other causes (e.g., trauma or rupture of fusiform or mycotic aneurysms). 2. Patients with intraventricular or intracerebral blood, in the absence of subarachnoid blood. 3. No visualized clot or presence of only localized thin clot on CT (=34 %) or severe cerebral vasospasm on screening angiogram. 5. Patients with hypotension (systolic blood pressure (SBP) =2 mg/dl (177 micromol/l) and/or total bilirubin > 3 mg/dl (51.3 micromol/l). 9. Any known or CT evidence of previous major cerebral damage (e.g., stroke [> 2 cm], traumatic brain injury [> 2 cm], previously treated cerebral aneurysm, arterial venous malformation [AVM]), or other preexisting cerebrovascular disorders, which may affect accurate diagnosis and evaluation of SAH. 10. Patients receiving prophylactic i.v. nimodipine or i.v. nicardipine. If present, these must be stopped at least 4 hours prior to initiation of the study treatment. 11. Patients who have received thrombolytics, including intracisternal administration, intrathecal treatments and therapeutic hypothermia for treatment of the SAH. 12. Patients who have received an investigational product within 28 days prior to randomization. 13. Patients with current alcohol or drug abuse or dependence.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy of 3 dose levels (1 mg/h, 5 mg/h and 15 mg/h) of clazosentan in preventing the occurrence of cerebral vasospasm following aSAH;Secondary Objective: · To assess the ability of clazosentan to reduce the occurrence of early morbidity/mortality. · To assess the effect of clazosentan on clinical outcome. · To assess the safety and tolerability of three dose levels of clazosentan.;Primary end point(s): Occurrence of moderate or severe cerebral vasospasm, as measured by cerebral angiography at Day 9 ± 2 post-aneurysm rupture. If the patient develops clinical or sonographic changes suggestive of vasospasm prior to or after Day 9 ± 2 and until Day 14 post-aneurysm rupture, an angiogram will be performed to confirm the vasospasm. If vasospasm is documented prior to Day 9 ± 2, the Day 9 ± 2 angiogram is no longer required. In the case that a patient only develops clinical symptoms suggestive of vasospasm later than Day 9 ± 2 and up to Day 14, an additional angiogram should be performed to confirm the diagnosis of vasospasm. If the latter shows a higher grade of vasospasm than the previous one, it will be used for comparison to the baseline angiogram for evaluation of the primary endpoint. | — |
Countries
Austria, Belgium, Finland, Germany, Italy, Sweden
Outcome results
None listed