Could a common transplant drug tame dangerous brain aneurysms?
NCT ID NCT04141020
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests whether sirolimus, a drug used to prevent organ rejection, can reduce harmful inflammation inside brain aneurysms. Researchers will give the drug to some patients before standard surgery or coiling and compare tissue and blood samples to those not receiving the drug. The goal is to see if sirolimus changes gene activity linked to aneurysm growth and rupture risk.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Sirolimus (also known as Rapamune), an oral medication that may reduce inflammation and abnormal cell growth in blood vessels.
- What this could lead to
- If successful, this could point toward a drug treatment to stabilize brain aneurysms and reduce the risk of rupture, potentially lowering the need for surgery.
- What could go wrong
- This is a small, early-phase study focused on molecular changes, not on preventing rupture. Sirolimus has side effects like mouth sores and increased infection risk, and it may not show clear benefit.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 80 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2021
- Expected to finish
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Nov 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Undergoing one of the following procedures at Jackson Memorial Hospital: * Clipping of an unruptured cerebral artery aneurysm * Endovascular treatment of unruptured cerebral aneurysms (including those receiving coiling) 2. ≥ 18 years of age 3. Willing and able to give informed consent Exclusion Criteria: 1\) Subjects meeting any of the following criteria will be excluded: * Dissecting, traumatic, or mycotic brain aneurysm. * Women who are pregnant, or have a positive urine or blood (β-hCG) pregnancy test. * Women who are breastfeeding. * Any clinically significant psychiatric or psychological disease, which would preclude the patient from completing the protocol. * Patients with known Human Immunodeficiency Virus (HIV) infection or other known immunodeficiency. * Patient with renal or liver failure * Interstitial pneumonitis * History of lymphoma * History of skin cancer * Hypersensitivity to sirolimus * Severe or unstable concomitant condition disease or chronic condition, which in the opinion of the investigator could affect assessment of the safety or efficacy of study intervention.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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University of Miami
RECRUITINGMiami, Florida, 33136, United States
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