CompletedPhase 1/2

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

United States80 participantsStarted 2018-07-17

Plain-language 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.

Who can participate

Age range18 Years – 80 Years

SexALL

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Inclusion criteria

✓. 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, for more than 7 continuous days or greater than 14 total days within 12 months preceding enrollment.
✕. Indication to use statin medication for current approved indication, unrelated to CCM
✕. Known allergy or intolerance to statins

What they're measuring

Percent Change in Mean Lesional QSM (QSM Change Score)

Timeframe: 2 years of follow-up

Trial details

NCT IDNCT02603328

SponsorUniversity of Chicago

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-07-31

Results submitted2025-06-10

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