TABLE.
Inclusion and Exclusion Criteria
Inclusion criteria | |
Age 18 to 80 (inclusive). | |
Asymptomatic, mild or moderate disability requiring some help but able to attend own bodily needs without assistance. Defined as modified Rankin score (mRS) 0 to 3. | |
Diagnosis of CCM of any genotype supported by relevant imaging studies, where surgical resection is not performed after due consideration per current standard of care. | |
Symptomatic CCM bleeding event within 1 yr prior to enrollment. | |
Must be willing/able to travel to the study site for study visits (baseline, 12 and 24 mo) over the course of the study. | |
Exclusion Criteria | |
Premenopausal women who are breastfeeding, pregnant or likely to get pregnant during the study period. | |
Prior surgical treatment of the hemorrhagic CCM lesion. | |
Failure to pass MRI safety screening (claustrophobic, metal implant, etc.). | |
Known allergy or intolerance to gadolinium. | |
Severely impaired renal function (eGFR < 60 ml/min), active renal disease or status postkidney transplants. | |
Statin therapy, for any indication, within 12 mo preceding enrollment. | |
Indication to use statin medication for current approved indication, unrelated to CCM. | |
Known allergy or intolerance to statins. | |
Liver dysfunction or active liver disease (including chronic viral hepatitis) defined as baseline serum transaminases levels twice the upper range of normal. | |
Previous diagnosis of skeletal muscle disorders of any cause (myopathy), or baseline creatine kinase levels five times the upper range of normal. | |
Currently treated with or likely to need treatment with a prohibited medication (Cyclosporine, fibrates, niacin, Azol antifungals, HIV/HCV protease inhibitors, macrolides or colchicine). | |
Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements. | |
Serious illness (requiring systemic treatment and/or hospitalization) until subject either completes therapy or is clinically stable on therapy, in the opinion of the site investigator, for at least 30 d prior to study entry. | |
Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated, including conditions resulting in or precipitating myopathy (eg, HIV, uncontrolled hypothyroidism). | |
In the investigator's opinion, the patient is unstable, and would benefit from a specific intervention rather than treatment with atorvastatin. | |
Inability or unwillingness of subject or legal guardian/representative to give written informed consent. | |
No documentation of valid healthcare insurance. | |
No medical record confirmation of a primary care physician or other provider of ongoing medical care. | |
Previous cranial irradiation or radiosurgical treatment. |