A Prospective, Multi-Center, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Phase 3 Study To Assess The Efficacy And Safety Of Clazosentan In Preventing Clinical Deterioration Due To Delayed Cerebral Ischemia (Dci), In Adult Subjects With A
Posted Date: Sep 25, 2019
- Investigator: Charles Prestigiacomo
- Specialties: Neurology, Neurosurgery, Stroke, Vascular
- Type of Study: Drug
A prospective, multi-center, double-blind, randomized, placebo-controlled, parallel-group, Phase 3 study to assess the efficacy and safety of clazosentan in preventing clinical deterioration due to delayed cerebral ischemia (DCI), in adult subjects with aneurysmal subarachnoid hemorrhage (aSAH). In previous and currently ongoing clinical research studies, clazosentan has already been safely administered to more than 1500 subjects with aneurysmal subarachnoid hemorrhage. The available information suggests that clazosentan can prevent a number of medical complications related to vasospasm (narrowing of blood vessels). Clazosentan also shows the potential to reverse vasospasm if initiated early enough. Despite the information already collected from previous research, the present study is being conducted to confirm the effectiveness of clazosentan in a group of subjects that is expected to benefit the most from treatment with it. In this study, clazosentan is being tested against normal routine medical care to determine if clazosentan can reduce the risk of developing complications related to vasospasm and permanent brain damage. The side effects of clazosentan will also be evaluated.
Males And (Non-Pregnant Or Breastfeeding) Females Aged 18 To 70 Years, Inclusive. Subjects With A Ruptured Saccular Aneurysm, Angiographically Confirmed By Dsa Or Cta, Which Has Been Successfully Secured Within 72 Hours Of Rupture, By Surgical Clipping Or Endovascular Coiling. Wfns Grades 1-4 (Based On Glasgow Coma Scale, Gcs) Assessed After Recovery From The Aneurysm-Securing Procedure And After External Ventricular Drainage For Hydrocephalus, If Required. High-Risk Prevention: Subjects With A “Thick And Diffuse Clot” On The Hospital Admission Ct Scan, Absence Of Cerebral Vasospasm At The Time Of Randomization, And Possibility To Start Study Drug In The Icu (Or Equivalent Environment Where All Protocol Assessments Can Be Performed And The Patient Management Guidelines Followed), Within 96 Hours Following The Time Of Aneurysm Rupture Or Early Treatment: Subjects Without A “Thick And Diffuse Clot” On The Hospital Admission Ct Scan Who Develop Asymptomatic Or Minimally Symptomatic Moderate To Severe Angiographic Vasospasm, Within The 14-Day Period Post-Aneurysm Rupture, And For Whom It Is Possible To Start Study Drug In The Icu (Or Equivalent Environment Where All Protocol Assessments Can Be Performed And The Patient Management Guidelines Followed), Within 24 Hours Of This Angiographic Diagnosis. Presence Of A Cerebral Ct Scan, Performed At Least 8 Hours Post-Aneurysm-Securing Procedure And Within 24 Hours Prior To Randomization, Which Rules Out A Significant (E.G., Symptomatic) New Or Worsened Cerebral Infarct Or Re-Bleeding Of The Repaired Aneurysm, Associated With Clinical Symptoms.
Delayed Cerebral Ischemia, Aneurysmal Subarachnoid Hemorrhage, Clazosentan
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