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

StatusRecruiting
PhasePhase 4
Started
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Record History

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  1. Enrollment target: 364 to 354
    • Collaborators expanded, about 72 words
    v5
  2. Primary endpoint revisedv4 Show 8 more changesShow less
    • Enrollment target: 386 to 364
    • Primary completion date: Aug 1, 2027 to Dec 1, 2027
    • Study completion date: Aug 31, 2027 to Dec 31, 2027
    • Start date: Aug 30, 2024 to Jul 30, 2024
    • Eligibility criteria expanded, about 261 words
    • Secondary endpoint revised
    • Study description shortened, about 727 words
    • Study title shortened, about 1 word
  3. Lead sponsor: Zhujiang Hospital to Duan Chuanzhiv3 Show 4 more changesShow less
    • Trial status: Not Yet Recruiting to Recruiting
    • Primary completion date: Mar 31, 2027 to Aug 1, 2027
    • Study completion date: Jul 31, 2027 to Aug 31, 2027
    • Start date changed from estimate of Jul 5, 2024 to Aug 30, 2024
  4. Start date: Mar 5, 2024 to Jul 5, 2024v2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Duan Chuanzhi
3 trials monitored
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Stroke
3,531 trials monitored
See 153 trials at risk
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.
Trial Details
NCT Number NCT06308952
Lead Sponsor Duan Chuanzhi
Collaborators: Shenzhen Second People's Hospital, First Affiliated Hospital of Harbin Medical University, ZhuHai Hospital, First Hospital of Shijiazhuang City, Eighth Affiliated Hospital, Sun Yat-sen University, First Affiliated Hospital of Jinan University, Dongguan Kanghua Hospital, Beijing Tiantan Hospital, Guangdong 999 Brain Hospital, The First Affiliated Hospital of Zhengzhou University, First Affiliated Hospital of Chongqing Medical University, Dongguan People's Hospital, Xinqiao Hospital of Chongqing, Shanxi Cardiovascular Hospital, Peking Union Medical College Hospital, Tianjin Huanhu Hospital
Conditions
(from sponsor)		 Cerebrovascular Event, Stent Stenosis, Ischemic Stroke, Hemorrhagic Stroke, Stent Thrombosis, Death, Brain, Endothelial Dysfunction
Related terms Brain Death, Hemorrhagic Stroke, Intracranial Aneurysm, Ischemic Stroke, Stroke
Enrollment 354 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov