Atorvastatin for Cavernous Hemangioma
(AT CASH EPOC Trial)
Trial Summary
What is the purpose of this trial?
This trial is testing if atorvastatin can help patients who had a recent brain bleed by reducing iron deposits in their brain. Atorvastatin has shown potential in reducing lesion development and hemorrhage in cerebral cavernous angiomas. The study will use MRI scans to measure changes over time.
Will I have to stop taking my current medications?
The trial protocol does not specify if you need to stop taking your current medications, but it does exclude people who are currently treated with or likely to need treatment with certain prohibited medications. It's best to discuss your specific medications with the trial team.
What data supports the effectiveness of the drug Atorvastatin for treating cavernous hemangioma?
Is atorvastatin safe for humans?
How does the drug atorvastatin differ from other treatments for cavernous hemangioma?
Research Team
Daniel F Hanley, MD
Principal Investigator
Director, Division of Brain Injury Outcomes Service The Johns Hopkins Medical Institutions
Issam A Awad, MD
Principal Investigator
Director of Neurovascular Surgery University of Chicago Medicine and Biological Sciences
Eligibility Criteria
This trial is for individuals with a recent symptomatic bleed from Cavernous Hemangioma, who can visit the study site regularly. Excluded are those allergic to statins, with liver disease, substance abuse issues, serious illnesses not stable for 30 days, pregnant or likely to become so during the study, prior treatments on CCM lesion, MRI safety concerns (like metal implants), severe kidney issues or on certain medications.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive atorvastatin or placebo and are monitored for changes in CCM lesional iron deposition using MRI studies
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Atorvastatin
- Placebo
Atorvastatin is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:
- Hypercholesterolemia
- Mixed dyslipidemia
- Homozygous familial hypercholesterolemia
- Hypercholesterolemia
- Mixed dyslipidemia
- Homozygous familial hypercholesterolemia
- Prevention of cardiovascular disease
- Hypercholesterolemia
- Mixed dyslipidemia
- Homozygous familial hypercholesterolemia
- Prevention of cardiovascular disease
- Hypercholesterolemia
- Mixed dyslipidemia
- Homozygous familial hypercholesterolemia
- Hypercholesterolemia
- Mixed dyslipidemia
- Homozygous familial hypercholesterolemia
- Hypercholesterolemia
- Mixed dyslipidemia
- Homozygous familial hypercholesterolemia
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Chicago
Lead Sponsor
Johns Hopkins University
Collaborator