Atorvastatin Treatment of Cavernous Angiomas With Symptomatic Hemorrhage Exploratory Proof of Concept (AT CASH EPOC) Trial

  • STATUS
    Recruiting
  • End date
    Aug 24, 2022
  • participants needed
    80
  • sponsor
    University of Chicago
Updated on 24 January 2021

Summary

This phase I/II randomized, placebo-controlled, double-blinded, single-site clinical trial is designed to investigate the effect of a prolonged course of atorvastatin versus placebo on CCM lesional iron deposition assessed by validated quantitative susceptibility mapping (QSM) MRI studies in patients who suffered a symptomatic bleed within the preceding one year.

Description

This phase I/II randomized, placebo-controlled, double-blinded, single-site clinical trial is designed to investigate the effect of a prolonged course of atorvastatin versus placebo on CCM lesional iron deposition assessed by validated quantitative susceptibility mapping (QSM) MRI studies in patients who suffered a symptomatic bleed within the preceding one year. Subjects will also be assessed by lesional and brain vascular permeability MRI using dynamic contrast enhanced quantitative perfusion (DCEQP) and a number of clinical evaluation tools. Subjects shall be followed for 2 years from randomization, the period of highest likelihood of rebleed after a recent CCM hemorrhage. Subjects will undergo clinical and MRI evaluations at baseline, and at 12 and 24 months during the study period. Enrolled subjects and the treating team will be blinded to treatment group allocation.

Details
Condition Cerebral Cavernous Malformation
Treatment Atorvastatin, Placebo
Clinical Study IdentifierNCT02603328
SponsorUniversity of Chicago
Last Modified on24 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 18 yrs and 80 yrs?
Gender: Male or Female
Do you have Cerebral Cavernous Malformation?
Do you have any of these conditions: Do you have Cerebral Cavernous Malformation??
Diagnosis of CCM of any genotype supported by relevant imaging studies
Symptomatic CCM bleeding event within 1 year prior to enrollment
Must be willing/able to travel to the study site for all study visits (baseline, 12 months, and 24 months) over the course of the study period

Exclusion Criteria

Pre-menopausal women who are breastfeeding, pregnant or likely to get pregnant during the study period
Previous cranial irradiation or surgical/radiosurgical treatment of CCM lesion
Failure to pass MRI safety screening (claustrophobia, metal implant . . . etc)
Known allergy or intolerance to gadolinium
Severely impaired renal function (eGFR < 60ml/min), active renal disease or status post-kidney transplants
Statin therapy, for any indication, within 12 months 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 level five times the upper range of normal
Currently treated with or likely to need treatment with one or more of prohibited medications listed in the protocol
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 days 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 (e.g. 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 primary care physician
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