PCSK9 Inhibitor With Statin Therapy for Asymptomatic Intracranial Atherosclerosis
Condition(s) studied
Investigational drug(s) / intervention(s)
Recaticimab and Statin: Recaticimab (450mg every 12 weeks subcutaneously) combined with rosuvastatin 10mg qn or atorvastatin 20mg qn
Statin: Rosuvastatin 10mg qn or atorvastatin 20mg qn
Study summary
This is a prospective, multicenter, open-label, blinded-endpoint, randomized controlled trial designed to evaluate the efficacy and safety of PCSK9 inhibitor combined with statin therapy compared to statin monotherapy in reversing asymptomatic intracranial atherosclerosis, assessed using high-resolution magnetic resonance imaging of the intracranial vessel walls.
Eligibility
Primary outcome measure(s)
- Change in plaque burden from baseline to week 24 — From baselie to the end of treatment at 24 weeks
Intracranial plaque burden was assessed at maximum stenosis site by high-resolution magnetic resonance imaging, performed at baseline and the end of the treatment period (24 \[±1\] week) on the same machine. The plaque burden is calculated according to the following formula: plaque burden = \[(vessel wall cross-sectional area - lumen cross-sectional area ) / vessel wall cross-sectional area\] ×100%. The outcome will be centrally assessed by an independent core imaging laboratory blinded to treatment allocation according to a predefined imaging analysis protocol.
Trial sites (19)
| Facility | City | Region | Status |
|---|---|---|---|
| Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College | Beijing | Beijing Municipality | Recruiting |
| Chinese PLA General Hospital | Beijing | Beijing Municipality | Not Yet Recruiting |
| The Third Affiliated Hospital of Sun Yat-sen University, Yuedong Hospital | Meizhou | Guangdong | Not Yet Recruiting |
| Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine | Cangzhou | Hebei | Not Yet Recruiting |
| Peking University Third Hospital Qinhuangdao Hospital | Qinhuangdao | Hebei | Not Yet Recruiting |
| Hebei Provincial People's Hospital | Shijiazhuang | Hebei | Recruiting |
| Tangshan Worker's Hospital | Tangshan | Hebei | Not Yet Recruiting |
| First Affiliated Hospital of Harbin Medical University | Harbin | Heilongjiang | Not Yet Recruiting |
| The first affiliated hospital of zhengzhou university | Zhengzhou | Henan | Not Yet Recruiting |
| Taihe Hospital | Shiyan | Hubei | Not Yet Recruiting |
| Zhongnan Hospital of Wuhan University | Wuhan | Hubei | Not Yet Recruiting |
| Baotou Central Hospital | Baotou | Inner Mongolia | Not Yet Recruiting |
| Nanjing First Hospital | Nanjing | Jiangsu | Not Yet Recruiting |
| Jining First People's Hospital | Jining | Shandong | Not Yet Recruiting |
| Liaocheng People's Hospital | Liaocheng | Shandong | Not Yet Recruiting |
| The Affiliated Hospital of Qingdao University | Qingdao | Shandong | Not Yet Recruiting |
| Weifang People's Hospital | Weifang | Shandong | Not Yet Recruiting |
| Chongqing General Hospital | Chongqing | China | Not Yet Recruiting |
| Huashan Hospital, Fudan University | Shanghai | China | Not Yet Recruiting |
More Peking Union Medical College Hospital trials in China
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06902740 on ClinicalTrials.gov ↗ ← All trials in China