Atorvastatin Pretreatment in Cerebrovascular Events (APICES) After Flow Diverter Implantation (NCT06308952) | Clinical Trial Compass
RecruitingPhase 4
Atorvastatin Pretreatment in Cerebrovascular Events (APICES) After Flow Diverter Implantation
China354 participantsStarted 2024-07-30
Plain-language summary
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. The study was approved by the Ethics Committee of Zhujiang Hospital of South Medical University (2024-KY-032-02) and registered at ClinicalTrials.gov (NCT06308952). The participants will be recruited from twelve advanced stroke centers in China.
Who can participate
Age range18 Years ā 75 Years
SexALL
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Inclusion criteria
ā. Aged 18 to 75 years old, male or non-pregnant female;
ā. UIA diagnosed by CTA, MRA, or DSA;
ā. Maximal aneurysmal diameter between 3 and 25mm;
ā. Understands the nature of the procedure and provision of written informed consent;
ā. Indications for FD implantation with or without adjunctive coiling;
ā. Is willing to return to the investigational site for follow-up according to our protocol.
Exclusion criteria
ā. Contraindications to atorvastatin treatment or known allergy to atorvastatin;
. Prolonged statin therapy (ā„30 days) or prior indications for atorvastatin therapy according to the Chinese guidelines for lipid management (2023) 21;
ā. Ruptured aneurysms or target aneurysm received previous operative or endovascular treatment;
ā. 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.);
ā. Patients diagnosed with multiple intracranial aneurysms who require treatment for two or more intracranial aneurysms within a one-year period;
ā. The target aneurysm is non-saccular (dissecting, fusiform, pseudo, infectious, etc.)