PCSK9 Inhibitor With Statin Therapy for Asymptomatic Intracranial Atherosclerosis
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-80
SponsorPeking Union Medical College Hospital
About this trial
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 criteria
Qualifiers
Age ≥18 and ≤80, male or female;
Asymptomatic intracranial artery stenosis (50%-99%) in the internal carotid artery (C6-7 segments), middle cerebral artery (M1 segment), vertebral artery (V4 segment), or basilar artery, confirmed by angiography (MRA, CTA, or DSA);
Atherosclerosis identified as the cause of intracranial artery stenosis by high-resolution magnetic resonance imaging;
No previous ischemic cerebrovascular events (including ischemic stroke or transient ischemic attack).
Disqualifiers
Non-atherosclerotic intracranial artery stenosis, including arterial dissection; moya moya disease; systemic vasculitis and primary central nervous system vasculitis; varicella-zoster vasculopathy or other viral vasculopathy; neurosyphilis and other intracranial infections, radiation vasculopathy; fibromuscular dysplasia, sickle cell disease, neurofibromatosis; reversible cerebral vasoconstriction syndrome; postpartum vasculopathy; suspected vasospasm, suspected reperfusion after vessel occlusion.
Upstream tandem extracranial vessel stenosis (≥50%) adjacent to the target intracranial stenotic vessel.
Previous treatment of target intracranial lesion with endovascular intervention or plan to perform endovascular intervention within 6 months, including intracranial stenting, endovascular angioplasty, and thrombectomy.
Any intracranial hemorrhage (parenchymal, subarachnoid, subdural, extradural, intraventricular) within 90 days prior to enrollment.
Trial design
Treatments tested in this trial
- Recaticimab and Statin
- Statin
Treatment groups
300 Participants
are divided into 2 treatment groupsSponsors and collaborators
Peking Union Medical College Hospital
Lead sponsor
Chinese PLA General Hospital
Collaborator
Hebei General Hospital
Collaborator
Taihe Hospital
Collaborator
Weifang People's Hospital
Collaborator
Nanjing First Hospital, Nanjing Medical University
Collaborator
Baotou Central Hospital
Collaborator
Jining First People's Hospital
Collaborator
Liaocheng People's Hospital
Collaborator
Tangshan Worker's Hospital
Collaborator
Chongqing General Hospital
Collaborator
First Affiliated Hospital of Harbin Medical University
Collaborator
Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine
Collaborator
The First Affiliated Hospital of Zhengzhou University
Collaborator
The Affiliated Hospital of Qingdao University
Collaborator
Zhongnan Hospital
Collaborator
Huashan Hospital
Collaborator
Source ClinicalTrials.gov