Actively Recruiting

Phase 4
Age: 18Years - 75Years
All Genders
NCT06308952

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

Led by Duan Chuanzhi · Updated on 2026-03-03

354

Participants Needed

1

Research Sites

178 weeks

Total Duration

On this page

Sponsors

D

Duan Chuanzhi

Lead Sponsor

S

Shenzhen Second People's Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged 18 to 75 years old, male or non-pregnant female
  • Diagnosed with unruptured intracranial aneurysm by CTA, MRA, or DSA
  • Maximal aneurysmal diameter between 3 and 25 mm
  • Understands the procedure and provides written informed consent
  • Eligible for flow diverter implantation with or without adjunctive coiling
  • Willing to return to the investigational site for follow-up as per protocol
Not Eligible

You will not qualify if you...

  • Contraindications or known allergy to atorvastatin
  • Pregnancy or lactation
  • Presence of other vascular lesions such as coronary artery disease, abdominal aortic aneurysm, intracranial atherosclerotic stenosis, arteriovenous malformation, dural arteriovenous fistula, Moyamoya disease
  • Prolonged statin therapy (30 days or more) or prior indications for atorvastatin therapy
  • Ruptured aneurysms or previous treatment on target aneurysm
  • Current use of drugs interacting with atorvastatin metabolism
  • Multiple intracranial aneurysms requiring treatment of two or more within one year
  • Target aneurysm is non-saccular (dissecting, fusiform, pseudo, infectious, etc.)
  • Unsuitable for inclusion due to allergy or contraindications to anti-platelet or anticoagulant medication, FD alloy, contrast dye, or intolerance to anesthesia
  • Unwilling or unlikely to comply with follow-up
  • Life expectancy less than 3 years
  • Severe neurological deficit preventing independent living (modified Rankin score 4 or higher)
  • Participation in another clinical trial

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Zhujiang Hospital of Southern Medical University

Guangzhou, Guangdong, China, 510280

Actively Recruiting

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Research Team

C

Chuanzhi Duan, MD

CONTACT

X

Xin Feng, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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