Clinical Trial: Atorvastatin Therapy in Cerebral Cavernous Malformation: A Proof of Concept Phase I/II Trial

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional




Official Title: Phase I-II Randomized, Placebo-Controlled, Single-Blinded, Single-Site Clinical Trial of Atorvastatin in the Treatment of Cerebral Cavernous Malformation

Brief Summary: The study aims to demonstrate that extended course atorvastatin therapy reduces lesional iron deposition without increasing the risk of rebleeding (acute hemorrhage) in patients with cerebral cavernous malformation (CCM). Subjects will be randomized to daily atorvastatin (20,40 or 80mg PO) or placebo and followed for 36 months, or until a clinically overt CCM hemorrhage or attrition from drug related adverse events. Subjects will undergo a total of four MRI scans with biomarker studies, and serial clinical assessments.