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Statins

Atorvastatin for Cavernous Hemangioma (AT CASH EPOC Trial)

Phase 1 & 2

Waitlist Available

Research Sponsored by University of Chicago

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of CCM of any genotype supported by relevant imaging studies

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up end of study (24-month) mri scan

Awards & highlights

AT CASH EPOC Trial Summary

This trial is designed to see if atorvastatin can help with iron deposition in CCM lesions, as assessed by MRI.

Who is the study for?

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.Check my eligibility

What is being tested?

The AT CASH EPOC trial is testing whether atorvastatin reduces iron deposits in brain lesions caused by bleeding cavernous hemangiomas versus a placebo. It's randomized and double-blinded—meaning neither participants nor researchers know who gets the drug or placebo—and involves regular MRI scans over two years.See study design

What are the potential side effects?

Atorvastatin may cause side effects like muscle pain or weakness (myopathy), liver problems (evident through blood tests), digestive issues such as nausea and constipation, headaches and potential increased risk of diabetes.

AT CASH EPOC Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My imaging tests show I have cerebral cavernous malformations.

Select...

I can travel to the study site for all required visits over 2 years.

AT CASH EPOC Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ end of study (24-month) mri scan

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~end of study (24-month) mri scan

This trial's timeline: 3 weeks for screening, Varies for treatment, and end of study (24-month) mri scan for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Percent QSM change per year

mean percent change in lesional QSM per year (called the change score)

Secondary outcome measures

Adverse event rates

Changes in DCEQP vascular permeability measurements in the index lesion and in brain (white matter far from lesion)

Changes in functional outcome as measured using the modified Rankin scale which measures the degree of disability or dependence in patients with neurological disability.

+6 more

AT CASH EPOC Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: TreatmentActive Control1 Intervention

Atorvastatin 80mg OD (optimal dose). Treatment dose will be de-escalated to 40mg based on reported adverse events.

Group II: PlaceboPlacebo Group1 Intervention

Identically looking capsules containing no active ingredient

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of ChicagoLead Sponsor

1,003 Previous Clinical Trials

819,669 Total Patients Enrolled

3 Trials studying Cerebral Cavernous Malformations

2,021 Patients Enrolled for Cerebral Cavernous Malformations

Johns Hopkins UniversityOTHER

2,260 Previous Clinical Trials

14,820,700 Total Patients Enrolled

1 Trials studying Cerebral Cavernous Malformations

181 Patients Enrolled for Cerebral Cavernous Malformations

Daniel F Hanley, MDStudy ChairDirector, Division of Brain Injury Outcomes Service The Johns Hopkins Medical Institutions

1 Previous Clinical Trials

52 Total Patients Enrolled

Media Library

Atorvastatin (Statins) Clinical Trial Eligibility Overview. Trial Name: NCT02603328 — Phase 1 & 2

Cerebral Cavernous Malformations Research Study Groups: Treatment, Placebo

Cerebral Cavernous Malformations Clinical Trial 2023: Atorvastatin Highlights & Side Effects. Trial Name: NCT02603328 — Phase 1 & 2

Atorvastatin (Statins) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02603328 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What maladies is this remedial protocol typically employed to address?

"This therapeutic intervention is typically employed to manage lipidemia, but can be useful for postoperative thromboembolism, anginal pain, and transient ischemic attack."

Answered by AI

Who is eligible to participate in this medical experiment?

"This medical trial requires 80 participants between 18-80 years old diagnosed with angioma, cavernous. Additional requirements include documented proof of CCM genotypes in imaging studies, a willingness to travel for study visits over two year period and evidence of symptomatic bleeding events within the prior 12 months."

Answered by AI

Is the recruitment phase of this experiment currently open?

"This trial is no longer seeking participants. First posted on the 17th of July 2018, this study was last updated 26th of July 2022. For those looking for other trials related to angioma and cavernous treatments, there are presently 475 active studies with 70 actively recruiting patients."

Answered by AI

Is the enrollment for this experiment including individuals over 85 years of age?

"This clinical trial seeks participants aged 18 to 80. Conversely, there are separate trials with age-specific conditions of 110 applicants below 18 and 428 above 65 years old."

Answered by AI

Is this investigation a groundbreaking venture?

"Worldwide, there are 70 ongoing trials for this therapy across 162 cities and 28 countries. The initial trial was commissioned by Merck Sharp & Dohme LLC in 2005 involving eighty patients that completed its fourth phase of drug approval; since then 18706 studies have been concluded."

Answered by AI

How many participants are engaged in this research endeavor?

"Sadly, this medical trial has closed its recruitment. It was first posted on the 17th July 2018 and last updated on 26th July 2022. Nonetheless, there are still 475 trials seeking patients with angioma cavernous and 70 studies recruiting for related treatments actively looking for volunteers to join them."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2018. "Atorvastatin Treatment of Cavernous Angiomas With Symptomatic Hemorrhage Exploratory Proof of Concept (AT CASH EPOC) Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02603328.

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