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

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.

Conditions

• Cerebrovascular Event
• Stent Stenosis
• Ischemic Stroke
• Hemorrhagic Stroke
• Stent Thrombosis
• Death, Brain
• Endothelial Dysfunction

Interventions

DRUG

Atorvastatin 20mg

Eligible 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).

Sponsors & Collaborators

• Shenzhen Second People's Hospital

  collaborator OTHER

• First Affiliated Hospital of Harbin Medical University

  collaborator OTHER

• ZhuHai Hospital

  collaborator OTHER

• First Hospital of Shijiazhuang City

  collaborator OTHER

• Eighth Affiliated Hospital, Sun Yat-sen University

  collaborator OTHER

• First Affiliated Hospital of Jinan University

  collaborator OTHER

• Dongguan Kanghua Hospital

  collaborator OTHER

• Beijing Tiantan Hospital

  collaborator OTHER

• Guangdong 999 Brain Hospital

  collaborator OTHER

• The First Affiliated Hospital of Zhengzhou University

  collaborator OTHER

• First Affiliated Hospital of Chongqing Medical University

  collaborator OTHER

• Dongguan People's Hospital

  collaborator OTHER_GOV

• Xinqiao Hospital of Chongqing

  collaborator OTHER

• Shanxi Cardiovascular Hospital

  collaborator OTHER

• Peking Union Medical College Hospital

  collaborator OTHER

• Tianjin Huanhu Hospital

  collaborator OTHER

• Duan Chuanzhi

  lead OTHER

Principal Investigators

• Chuanzhi Duan, MD · Southern Medical University, China

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-07-30

Primary Completion

2027-12-01

Completion

2027-12-31

FDA Drug

Yes

Countries

• China

Study Locations