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New treatment option for Cerebrovascular Event
Official title Atorvastatin Pretreatment in Cerebrovascular Events (APICES) After Flow Diverter Implantation
ClinicalTrials.gov ID: NCT06308952
What this study is testing
What is Atorvastatin 20mg?
Atorvastatin 20mg is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for cerebrovascular event.
Also referred to as Lipitor.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- APICES trial is an investigator-initiated, multicenter, multicenter, randomized, double-blind, placebo-controlled clinical trial that plans to enroll 396 patients with a 1-year follow-up, including a neurovascular imaging examination [digital subtraction angiography (DSA), CT angiography (CTA) or magnetic resonance angiography (MRA)] at 6 months after index treatment. It was designed in compliance with the Declaration of Helsinki and the International Conference on Harmonization Good Clinical Practice guidelines.
- Phase 4: studies an already-approved treatment
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Aged 18 to 75 years old, male or non-pregnant female;
- UIA diagnosed by CTA, MRA, or DSA;
- Maximal aneurysmal diameter between 3 and 25mm;
- Understands the nature of the procedure and provision of written informed consent;
- Indications for FD implantation with or without adjunctive coiling;
You likely can't join if
- Patients will be excluded if they meet any of the following criteria:
- Contraindications to atorvastatin treatment or known allergy to atorvastatin;
- Pregnancy or lactation;
- Presence of other vascular lesions (coronary artery disease, abdominal aortic aneurysm, intracranial atherosclerotic stenosis, arteriovenous...
- Prolonged statin therapy (≥30 days) or prior indications for atorvastatin therapy according to the Chinese guidelines for lipid management (2023) 21;
- Ruptured aneurysms or target aneurysm received previous operative or endovascular treatment;
See the full eligibility criteria
- Aged 18 to 75 years old, male or non-pregnant female;
- UIA diagnosed by CTA, MRA, or DSA;
- Maximal aneurysmal diameter between 3 and 25mm;
- Understands the nature of the procedure and provision of written informed consent;
- Indications for FD implantation with or without adjunctive coiling;
- Is willing to return to the investigational site for follow-up according to our protocol.
- Patients will be excluded if they meet any of the following criteria:
- Contraindications to atorvastatin treatment or known allergy to atorvastatin;
- Pregnancy or lactation;
- Presence of other vascular lesions (coronary artery disease, abdominal aortic aneurysm, intracranial atherosclerotic stenosis, arteriovenous malformation, dural arteriovenous fistula, Moyamoya disease, etc.);
- Prolonged statin therapy (≥30 days) or prior indications for atorvastatin therapy according to the Chinese guidelines for lipid management (2023) 21;
- Ruptured aneurysms or target aneurysm received previous operative or endovascular treatment;
- Patient currently using drugs that interact with atorvastatin metabolism (including transporter inhibitors, cyclosporine, protease inhibitors, other lipid-lowering medications (such as fibrates, ezetimibe, pcsk9...
- Patients diagnosed with multiple intracranial aneurysms who require treatment for two or more intracranial aneurysms within a one-year period;
- The target aneurysm is non-saccular (dissecting, fusiform, pseudo, infectious, etc.)
- 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...
- Patient was determined that intravenous general anesthesia or general anesthesia with tracheal intubation could not be tolerated.
- Unwilling to be followed up or likely to have poor treatment compliance at initial screening;
- Life expectancy less than 3 years;
- Severe neurological deficit that renders the patient unable to live independently (modified Rankin score ≥4);
- 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...
- The participants voluntarily quit the trial for various reasons;
- 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;
- Early termination of the process based on the investigator's judgment in order to prevent development of severe complications;
- Significant deviation in implementation, or the subject failed to comply with the scheduled protocol;
- 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...
- Flawed or absence of informed consents.
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, Guangdong, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guangzhou, Guangdong, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.