Could a $4 pill slash stroke risk after brain surgery? new trial aims to find out.
NCT ID NCT06308952
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether taking atorvastatin (a cholesterol-lowering drug) before and after a brain stent procedure can prevent strokes and other serious events. About 354 adults with brain aneurysms will be randomly assigned to receive either atorvastatin or a placebo. The goal is to see if the drug reduces the chance of stroke, stent narrowing, or death within one year.
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
-
Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
-
About 354 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Jul 2024
- Expected to finish
-
Dec 2027
An estimate. End dates often move.
- Lead sponsor
-
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
-
18 to 75 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion criteria: 1. Aged 18 to 75 years old, male or non-pregnant female; 2. UIA diagnosed by CTA, MRA, or DSA; 3. Maximal aneurysmal diameter between 3 and 25mm; 4. Understands the nature of the procedure and provision of written informed consent; 5. Indications for FD implantation with or without adjunctive coiling; 6. Is willing to return to the investigational site for follow-up according to our protocol. Exclusion criteria: Patients will be excluded if they meet any of the following criteria: 1. Contraindications to atorvastatin treatment or known allergy to atorvastatin; 2. Pregnancy or lactation; 3. Presence of other vascular lesions (coronary artery disease, abdominal aortic aneurysm, intracranial atherosclerotic stenosis, arteriovenous malformation, dural arteriovenous fistula, Moyamoya disease, etc.); 4. Prolonged statin therapy (≥30 days) or prior indications for atorvastatin therapy according to the Chinese guidelines for lipid management (2023) 21; 5. Ruptured aneurysms or target aneurysm received previous operative or endovascular treatment; 6. Patient currently using drugs that interact with atorvastatin metabolism (including transporter inhibitors, cyclosporine, protease inhibitors, other lipid-lowering medications (such as fibrates, ezetimibe, pcsk9 inhibitor, etc.), antacids, erythromycin, cytochrome P450 enzyme, colchicine, etc.); 7. Patients diagnosed with multiple intracranial aneurysms who require treatment for two or more intracranial aneurysms within a one-year period; 8. The target aneurysm is non-saccular (dissecting, fusiform, pseudo, infectious, etc.) 9. Other situations that the researcher deems unsuitable for inclusion in the study (inability to receive anti-platelet or anticoagulant medication; allergy or contraindication for the use of FD alloy, history of life-threatening allergy to contrast dye, ect). 10. Patient was determined that intravenous general anesthesia or general anesthesia with tracheal intubation could not be tolerated. 11. Unwilling to be followed up or likely to have poor treatment compliance at initial screening; 12. Life expectancy less than 3 years; 13. Severe neurological deficit that renders the patient unable to live independently (modified Rankin score ≥4); 14. Enrollment in another trial. Withdrawal criteria In this trial, participants who have provided written informed consent but are unable to complete the entire study for any reason will be withdrawn. These circumstances include the following: 1. The participants voluntarily quit the trial for various reasons; 2. Occurrence of serious adverse events (SAEs). The study may be terminated by the participants, principal investigators, ethics committee, sponsor, or regulatory authorities based on ethical considerations; 3. Early termination of the process based on the investigator's judgment in order to prevent development of severe complications; 4. Significant deviation in implementation, or the subject failed to comply with the scheduled protocol; 5. Miss the follow-up due to changes in working/living places, or fortuitous accident (traffic accident, bone fracture, accidental death, ect.). Thus, close follow-up should be conducted to determine their relationship with the usage of FD and experimental drug; 6. Flawed or absence of informed consents.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Cerebrovascular event are added.
Genom att skicka in godkänner du våra Användarvillkor
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.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
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
-
Zhujiang Hospital of Southern Medical University
RECRUITINGGuangzhou, Guangdong, 510280, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a checklist and heart monitor stop repeat strokes?
- Heart hole or stroke trigger? global registry tracks who gets closure and what happens next
- Two ways to catch a hidden heart rhythm after stroke
- Blood test may reveal who recovers after a stroke
- Can a smart bracelet and app stop a second stroke?
- Pharmacist and coach team takes aim at blood pressure after stroke