PCSK9 Inhibitor for Intracranial Atherosclerosis Related Acute Ischemic Stroke
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age30-80
SponsorPeking Union Medical College Hospital
About this trial
This study is a prospective, multicenter, double-blind, randomized, placebo-controlled clinical trial designed to evaluate whether early administration of PCSK9 inhibitors can effectively improve functional outcomes at 90 days in patients with ischemic stroke (AIS) associated with intracranial atherosclerotic stenosis (ICAS), primarily assessed using the modified Rankin Scale at 90 days.
Eligibility criteria
Qualifiers
Age >=30 and <=80;2.Acute ischemic stroke within 72 hours of onset (as determined by CT/MRI in conjunction with neurological deficit symptoms)
Acute ischemic stroke within 72 hours of onset (diagnosed by CT/MRI in conjunction with neurological deficit symptoms)
NIHSS score of 4-25 at admission
Imaging studies (CTA/DSA/MRA) support intracranial atherosclerosis as the cause of stroke, meeting one of the following criteria: i. The culprit vessel exhibits intracranial atherosclerotic stenosis (ICAS) with a narrowing degree of 50-99%; ii. The culprit vessel exhibits intracranial atherosclerotic occlusion (ICAS-LVO), with successful recanalization achieved via mechanical thrombectomy (immediate expanded thrombolysis in cerebral infarction [eTICI] grade 2b50-3)
Disqualifiers
Non-atherosclerotic intracranial arterial stenosis (such as arterial dissection, Moyamoya disease, systemic vasculitis, etc.)
Any identifiable source of cardiogenic embolism (such as atrial fibrillation, mechanical valves, left ventricular thrombus, patent foramen ovale, etc.)
Imaging findings and clinical presentation suggest that the primary pathophysiology of this event is more consistent with cerebral small vessel disease (e.g., perforator artery occlusion/lacunar infarction)
Pre-existing disability prior to this ischemic event (modified Rankin Scale ≥ 2 points)
Trial design
Treatments tested in this trial
- Rucacuzumab plus standard therapy
- Recaticimab plus placebo in combination with standard therapy
Treatment groups
1,212 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