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. 2018 Nov 26;85(6):843–853. doi: 10.1093/neuros/nyy539

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.