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 endovascular coiling - CONSCIOUS-3

Conditions: Aneurysmal Subarachnoid Hemorrhage
MedDRA version: 9.1Level: PTClassification code 10042316

Registration Number: EUCTR2008-006785-29-IT

Lead Sponsor: Actelion Pharmaceuticals Ltd

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 1470

Inclusion Criteria

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 endovascular coiling. The time of aneurysm rupture must be known or possible to estimate with a reasonable degree of certainty. 3) Patients with World Federation of Neurological Surgeons (WFNS) grade IIV measured prior to the endovascular coiling procedure, and which does not worsen to grade V post-procedure 4) Patients with any thick clot (short axis ≥ 4 mm) 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.
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

Exclusion Criteria

1) Patients with subarachnoid hemorrhage (SAH) due to causes other than a saccular aneurysm 2) Patients with giant aneurysms(height or width ≥ 25 mm). 3) Patients with intraventricular or intracerebral blood, in the absence of subarachnoid blood, or with only a thin clot(short axis < 4 mm). 4) Presence of cerebral vasospasm seen on angiography prior to the endovascular coiling procedure. 5)Patients who experienced 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 ≥ 12 hours post-aneurysm coiling). 6) Patients who have had their current ruptured aneurysm previously secured (successfully or not) by clipping. 7) Patients coiled with coiling material, which has not been approved by local health authorities. 8) Use of liquid embolism aneurysmal treatment or flow diverting device. 9) Patients with several aneurysms among which the ruptured one cannot be identified with certainty and which are not all secured during the coiling procedure. 10) Patients planned to have another securing procedure for any aneurysm after randomization and prior Week 12 postaSAH. 11) Patients for whom study drug cannot be started within 56 hours after the aneurysm rupture. 12) Patients with hypotension (systolic blood pressure (SBP) ≤ 90 mmHg) that is refractory to treatment. 13) Patients with aspiration pneumonia. 14) Patients with pulmonary edema or severe cardiac failure requiring inotropic support at the time of randomization. 15) 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. 16). Significant kidney and/or liver disease, as defined by plasma creatinine ≥ 2.5 mg/dL (221 μmol/l) and/or total bilirubin > 3 mg/dL (51.3 μmol/l) measured at the local laboratory. 17). 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. 18) Known hypersensitivity to other endothelin receptor antagonists.