EUCTR2007-002584-27-SE进行中（未招募）不适用
A prospective, multi-center, double-blind, randomized, placebo-controlled, parallel-group study to assess the efficacy and safety of clazosentan in reducing vasospasm-related morbidity and all-cause mortality in adult patients with aneurysmal subarachnoid hemorrhage treated by surgical clipping. - CONSCIOUS 2
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 1,146
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Males and females aged 18 to 75 years (inclusive).
- •2.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.
- •3.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])*
- •4.Patients with any diffuse clot (long axis >= 20 mm, or any clot present across both hemispheres) on baseline CT scan.
- •5.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.
- •6.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.
- •*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 (e.g., for high or unstable intracranial pressure [ICP]) may be included in the study provided that a CT scan is performed at least 12 hours post-procedure, but prior to randomization, ruling out any large procedure-related infarct.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Patients with SAH due to causes other than a saccular aneurysm (e.g., trauma or rupture
- •of fusiform or mycotic aneurysms).
- •2. Patients with intraventricular or intracerebral blood, in the absence of subarachnoid blood
- •or with only a local clot.
- •3. Presence of cerebral vasospasm seen on angiography prior to the clipping procedure.
- •4. 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 = 12 hours post-aneurysm clipping).*
- •5. Patients for whom study drug cannot be started within 56 hours after the aneurysm
- •6. Patients who have had their aneurysm secured by coiling only.
- •7. Patients for whom it is known, at time of screening, that certain follow-up protocolmandated
- •imaging assessments will not be feasible.
- •8. Patients with hypotension (systolic blood pressure (SBP) = 90 mmHg) that is refractory
- •to treatment.
- •9. Patients with aspiration pneumonia or pulmonary edema.
- •10. Patients with severe cardiac failure requiring inotropic support
- •11. Any severe or unstable concomitant condition or disease (e.g., known significant
- •neurological deficit, cancer, hematological, or coronary disease), or chronic condition
- •(e.g., psychiatric disorder), which in the opinion of the investigator would affect the
- •assessment of the safety or efficacy of the study drug.
- •12. Significant kidney disease, as defined by plasma creatinine >= 2.5 mg/dL (221 µmol/l), and/or liver disease, as defined by total bilirubin > 2 fold the Upper Limit of Normal (ULN) as measured at the local laboratory, and/or known diagnosis or clinical suspicion of liver cirrhosis.
- •13. Patients receiving i.v. nimodipine or i.v. nicardipine must have these drugs discontinued
- •at least 4 hours prior to initiation of the study treatment.
- •14. Patients receiving statins for less than 2 weeks prior to admission must have them
- •discontinued prior to study drug initiation.
- •15. Patients receiving cyclosporin A or other calcineurin inhibitors (e.g., tacrolimus), or
- •patients for whom it is known at time of randomization that these medications will be
- •started during the study drug infusion period.
- •16. Patients who have received an investigational product within 28 days prior to
- •randomization or those who have already participated in the current study.
- •17. Patient unlikely to comply with the protocol (e.g., unable to return for follow-up visits).
- •18. Known hypersensitivity to other endothelin receptor antagonists.
- •19. Patients with current alcohol or drug abuse or dependence.
研究者
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A prospective, multi-center, double-blind, randomized, placebo-controlled, parallel-group study to assess the efficacy and safety of clazosentan in reducing vasospasm-related morbidity and all-cause mortality in adult patients with aneurysmal subarachnoid hemorrhage treated by surgical clipping. - CONSCIOUS 2EUCTR2007-002584-27-ATActelion Pharmaceuticals Ltd.1,146