PCSK9 Inhibitor With Statin Therapy for Asymptomatic Intracranial Atherosclerosis
NCT06902740 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 300
Last updated 2025-08-07
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.
Conditions
- Intracranial Atherosclerosis
- Intracranial Artery Stenosis
- Atherosclerotic Plaque
Interventions
- DRUG
-
Recaticimab and Statin
Recaticimab (450mg every 12 weeks subcutaneously) combined with rosuvastatin 10mg qn or atorvastatin 20mg qn
- DRUG
-
Statin
Rosuvastatin 10mg qn or atorvastatin 20mg qn
Sponsors & Collaborators
-
Chinese PLA General Hospital
collaborator OTHER -
Hebei General Hospital
collaborator OTHER -
Taihe Hospital
collaborator OTHER -
Weifang People's Hospital
collaborator OTHER -
Nanjing First Hospital, Nanjing Medical University
collaborator OTHER -
Baotou Central Hospital
collaborator OTHER -
Jining First People's Hospital
collaborator OTHER -
Liaocheng People's Hospital
collaborator OTHER -
Tangshan Worker's Hospital
collaborator OTHER -
Chongqing General Hospital
collaborator OTHER -
First Affiliated Hospital of Harbin Medical University
collaborator OTHER -
Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine
collaborator OTHER -
The First Affiliated Hospital of Zhengzhou University
collaborator OTHER -
The Affiliated Hospital of Qingdao University
collaborator OTHER -
Zhongnan Hospital
collaborator OTHER -
Huashan Hospital
collaborator OTHER -
Peking Union Medical College Hospital
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 60 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-09-01
- Primary Completion
- 2027-12-31
- Completion
- 2028-12-31
Countries
- China
Study Locations
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