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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Rucacuzumab plus standard therapy
DrugRecaticimab (450 mg single dose, subcutaneous injection) combined with standard therapy recommended by the AHA/ASA Guidelines for Early Management of Acute Ischemic Stroke 2026 and the Chinese Guidelines for Diagnosis and Treatment of Acute Ischemic Stroke 2023.
Recaticimab plus placebo in combination with standard therapy
DrugThe placebo and investigational ricaximab were identical in appearance, packaging, labeling, administration method, and dosing frequency, managed through a unified production and coding system. Standard treatment followed the recommendations outlined in the "AHA/ASA Guidelines for the Early Management of Acute Ischemic Stroke 2026" and the "Chinese Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke 2023."
Treatment groups
1,212 Participants
are divided into 2 treatment groupsGroup A: Recaticimab plus standard therapy groupExperimental treatment 1 intervention
Group B: Recaticimab plus placebo in combination with standard therapy gropPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
90-day modified Rankin Scale (mRS) score of 0-2
Scoring using the modified Rankin Scale (mRS)
Time frame
Day 90 of patient enrollmentSecondary outcomes
1
90-day modified Rankin Scale (mRS) score of 0-1
Scoring using the modified Rankin Scale (mRS)
Time frame
Day 90 of patient enrollment2
Distribution of modified Rankin Scale (mRS) scores at 90 days
Scoring using the modified Rankin Scale (mRS)
Time frame
Day 90 of patient enrollment3
Time from randomization to the first-ever stroke
Stroke is a general term for acute cerebrovascular diseases, referring to brain tissue damage or death caused by rupture or blockage of intracranial blood vessels due to various causes. It can be classified into two major categories: hemorrhagic and ischemic, as determined by the project's Clinical Events Committee.
Time frame
From randomization to Day 90 of enrollment4
Time from randomization to the first-ever ischemic stroke
Ischemic Stroke: Defined as an acute cerebral infarction with clinical signs or imaging evidence of a new acute focal neurological injury persisting for more than 24 hours, excluding other non-ischemic causes.
Time frame
From randomization to Day 90 of enrollmentOther outcomes
1
NIHSS at 24 hours, 7 days, and discharge
Assessment using the National Institutes of Health Stroke Scale
Time frame
At 24 hours, 7 days, and at discharge2
Cerebral infarction volume or perfusion status at 7 days post-enrollment or at discharge
Evaluate using CT/CTP or MRI/PWI
Time frame
At 7 days post-enrollment or upon discharge3
Inflammation levels at 7 days post-group assignment or at discharge
Evaluated through markers such as interleukin IL-6 and high-sensitivity C-reactive protein
Time frame
At 7 days post-enrollment or upon discharge4
The proportion of subjects with moderate to severe symptomatic intracranial hemorrhage(sICH)
The diagnosis of symptomatic intracranial hemorrhage will be assessed based on the modified Heidelberg hemorrhage classification criteria, requiring simultaneous fulfillment of the following conditions: 1. Imaging confirmation of any of the following types of intracranial hemorrhage: parenchymal hemorrhage type 1, parenchymal hemorrhage type 2, distant intracranial hemorrhage, subarachnoid hemorrhage, intraventricular hemorrhage, or subdural hemorrhage; 2. An increase in total NIHSS score of ≥4 points compared to baseline NIHSS or any previously recorded NIHSS score; 3. Symptom deterioration cannot be explained by causes other than the intracranial hemorrhage itself.
Time frame
From randomization to Day 90 of enrollmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
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
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