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.
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;
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;
Parallel
Atorvastatin 20mg
DrugEligible subjects screened will enter the pretreatment period (at least 24 hours) and be randomly assigned to the trial group (oral atorvastatin) or the control group (placebo) to start receiving the trial drug (20mg, qd). Additionally, the patient was started on basic dual anti-platelet (aspirin 75mg qd + clopidogrel 75mg qd/ticagrelor 45mg bid).
Efficacy endopoint
Patients without new-onset cerebrovascular events within 12 months: 1. Any documented stroke (clinical and imaging): hemorrhage stroke (any intracranial hemorrhage subtype confirmed by CT scan) or ischemic stroke (neurological dysfunction more than 24 hours after onset or new acute cerebral infarction lesion confirmed by imaging); 2. the incidence of significant in-stent stenosis (a narrowing of the FD diameter exceeding 50% without pre-existing significant artery stenosis detected by 12-month angiographic follow-up).
Safety endpoint
1. muscle-related adverse events (excluding those due to exercise or trauma); 2. digestive system adverse events (dyspepsia, unexplained abdominal pain, biliary colic, gastrointestinal bleeding); 3. Newly diagnosed cancer, diabetes, neurocognitive disorders, cataracts; 4. all-caused death; 5. the incidence and the degree of ISS; 6. incomplete aneurysm occlusion; 7. new-onset in-stent thrombosis.
Click on the lead sponsor to view all of their trials.
Duan Chuanzhi
Lead sponsor
Zhujiang Hospital
Sponsor institution
Shenzhen Second People's Hospital
Collaborator
First Affiliated Hospital of Harbin Medical University
Collaborator
ZhuHai Hospital
Collaborator
First Hospital of Shijiazhuang City
Collaborator
Eighth Affiliated Hospital, Sun Yat-sen University
Collaborator
First Affiliated Hospital of Jinan University
Collaborator
Dongguan Kanghua Hospital
Collaborator
Beijing Tiantan Hospital
Collaborator
Guangdong 999 Brain Hospital
Collaborator
The First Affiliated Hospital of Zhengzhou University
Collaborator
First Affiliated Hospital of Chongqing Medical University
Collaborator
Dongguan People's Hospital
Collaborator
Xinqiao Hospital of Chongqing
Collaborator
Shanxi Cardiovascular Hospital
Collaborator
Peking Union Medical College Hospital
Collaborator
Tianjin Huanhu Hospital
Collaborator
