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 to 80 years, inclusive.
Acute ischemic stroke with symptom onset within 72 hours before screening, diagnosed on the basis of neurological deficits and CT or MRI findings.
National Institutes of Health Stroke Scale (NIHSS) score of 4 to 25 at hospital admission.
CTA, DSA, or MRA evidence that the culprit intracranial artery has atherosclerotic stenosis of 50% to 99%.
Disqualifiers
Intracranial arterial stenosis attributable to a nonatherosclerotic cause, such as arterial dissection, moyamoya disease, or systemic vasculitis.
Any definite source of cardioembolism, such as atrial fibrillation, a mechanical prosthetic heart valve, left ventricular thrombus, or patent foramen ovale.
Clinical and imaging findings suggesting that the index ischemic event is primarily attributable to cerebral small vessel disease.
Pre-stroke disability, defined as a modified Rankin Scale score of 2 or higher before the index ischemic event.
Trial design
Treatments tested in this trial
- Recaticimab plus standard therapy
- Recaticimab's 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