Atorvastatin Pretreatment in Cerebrovascular Events After Flow Diverter Implantation Protocol of a Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial

What this Trial Is About

The trial investigates patients with unruptured intracranial aneurysms (UIAs) undergoing flow diverter (FD) implantation, a treatment to prevent aneurysm rupture. It evaluates whether pretreatment with atorvastatin, a cholesterol-lowering drug that may also reduce inflammation and improve blood vessel function, can reduce complications compared to placebo. The study is a randomized, double-blind, placebo-controlled trial involving 396 patients with a one-year follow-up. Participants are randomly assigned to receive either atorvastatin 20mg or a placebo once daily for 180 days, alongside standard dual antiplatelet therapy. The study includes a pretreatment period of at least 24 hours before FD implantation. Follow-up includes neurovascular imaging exams such as digital subtraction angiography, CT angiography, or magnetic resonance angiography at 6 months after treatment. Throughout the trial, participants will undergo assessments including imaging, safety monitoring, and clinical evaluations to measure the trial's primary outcome of efficacy at one year and secondary safety outcomes. The study will track patients’ health status, adherence to medication, and any adverse events. Total participation spans at least one year with regular follow-up visits as per protocol.

Atorvastatin Pretreatment in Cerebrovascular Events (APICES) After Flow Diverter Implantation