PCSK9 Inhibitor for Intracranial Atherosclerosis Related Acute Ischemic Stroke (PISTIAS-3)

PCSK9 Inhibitor for Intracranial Atherosclerosis Related Acute Ischemic Stroke (PISTIAS-3): a Randomized, Double-blind, Placebo-controlled 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.

Study Overview

• Status: Not yet recruiting
• Conditions: Atherosclerotic Plaque; Acute Ischemic Stroke AIS; Intracranial Atherosclerosis ICAS
• Intervention / Treatment: Drug: Recaticimab plus standard therapy; Drug: Recaticimab's placebo in combination with standard therapy

Detailed Description

Acute ischemic stroke (AIS) remains one of the leading causes of death and disability worldwide. Although intravenous thrombolysis and endovascular therapies have significantly improved reperfusion success rates, three critical challenges persist in clinical practice that determine prognosis: First, only a limited proportion of patients can actually receive reperfusion therapy within the therapeutic time window; Second, even with successful reperfusion, secondary injuries such as microcirculatory perfusion failure, inflammatory cascades, and thrombus reformation may still occur. Third, acute phase fluctuations, particularly early neurological deterioration and the risk of early recurrence, remain prominent, directly limiting improvements in functional outcomes. 3 Intracranial atherosclerotic stenosis (ICAS) accounts for up to 50% of ischemic stroke etiologies in China. Its pathological chain-"plaque instability-thrombosis-microcirculatory impairment"-permeates both the acute and subacute phases, closely correlating with early recurrence and poor outcomes.Proprotein convertase subtilisin/kexin type 9 (PCSK9) classically promotes the degradation of low-density lipoprotein cholesterol (LDL-C) receptors and elevates LDL-C levels, thereby driving atherosclerosis progression. More importantly, growing basic and translational research suggests that PCSK9 may not only function as a "lipid metabolism protein" but also participate in processes such as endothelial activation, inflammatory cascades, platelet reactivity, and microcirculatory dysfunction. This positions it as a potential hub connecting the "plaque-thrombus-inflammation" axis. Consequently, PCSK9 inhibitors may offer additional neurovascular protective benefits beyond lipid-lowering effects during the acute phase of acute ischemic stroke (AIS).Existing basic and clinical evidence suggests that PCSK9 inhibitors may exert a combined intervention effect on key pathological processes driving atherosclerosis during the acute phase of AIS through a dual mechanism involving both lipid-dependent and non-lipid-dependent pathways. Mechanistic studies reveal that PCSK9 inhibition simultaneously modulates inflammatory responses, endothelial activation, dysfunction, and thrombogenic tendencies. In ischemia-reperfusion models, it demonstrates neuroprotective signaling by mitigating brain injury and improving neurological function. Clinically, large randomized trials confirm its ability to rapidly enhance lipid-lowering effects beyond statins and reduce ischemic stroke risk. Further translational evidence in cerebrovascular disease indicates that in symptomatic ICAS populations, PCSK9 inhibitor plus statin-enhanced lipid-lowering therapy reduces plaque burden, alleviates stenosis, and increases plaque stability. In the acute phase of AIS, early addition of PCSK9 inhibitors correlates with reduced neurological deterioration within 7 days, decreased recurrence risk within 30 days, and improved functional outcomes at 90 days. Collectively, this evidence chain spanning mechanisms to clinical practice provides clear scientific rationale and clinical necessity for adding PCSK9 inhibitors to the treatment of ICAS-associated AIS.This study is a nationwide, prospective, multicenter, double-blind, randomized, placebo-controlled clinical trial. It will enroll 1,212 patients meeting inclusion and exclusion criteria. Patients will be randomly assigned to two groups using a randomized allocation method: (1) Experimental group: 450 mg of Recaticimab for Injection (3 vials) administered as a single subcutaneous injection. (2) Control group: Placebo of Recaticimab for Injection 450 mg (3 vials) administered as a single subcutaneous injection. Each group will include 606 patients. Both groups will receive standard guideline-recommended treatment in addition to the study drug. Long-term efficacy was assessed through patient visits and evaluations at 0 hours, 24 hours (±2 or ±12 hours), 7 days (±2 days) or at discharge, 90 days (±7 days), and 1 year.Primary outcome measures included: Analysis based on the intention-to-treat principle using an ANCOVA model for all randomized patients with baseline HRMRI and a modified Rankin Scale (mRS) score of 0-2 at 90 days. Secondary outcome measures included: (1) mRS score of 0-1 at 90 days (indicating good patient function); (2) Distribution of 90-day mRS scores; (3) Any stroke (including ischemic and hemorrhagic) within 90 days; (4) Ischemic stroke within 90 days; (5) Composite vascular events (including stroke, myocardial infarction, and vascular death) within 90 days; (6) 90-day European Quality of Life 5-Dimension 5-Level Scale (EQ-5D-5L) score; (7) 90-day Barthel Index (BI) score.Details are provided in the "Outcome Measures" section.The sample size is calculated based on the primary outcome and a total of 1212 participants are anticipated. An independent Data Safety Monitoring Board will oversee the overall conduct of the trial.

• Study Type: Interventional
• Enrollment (Estimated): 1212
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Yiyang Liu, PhD; Phone Number: 86+13938912070; Email: liuyydoct@163.com
• Study Contact Backup: Name: Weihai Xu, MD; Phone Number: 86+13938912070; Email: xuwh@pumch.cn

Study Locations

• China
  • Beijing, China
    • Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, Beijing 100730
    • Contact: Weihai Xu, MD; Phone Number: 86+13651147766; Email: xuwh@pumch.cn
    • Principal Investigator: Weihai Xu, MD
  • Chongqing, China
    • Chongqing General Hospital
  • Shanghai, China
    • Huashan Hospital, Fudan University
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100853
      • Chinese PLA General Hospital
      • Contact: Shiwen Wu, MD; Phone Number: 86+13910238117; Email: wu_shiwen@outlook.com
      • Principal Investigator: Shiwen Wu, MD
  • Guangdong
    • Meizhou, Guangdong, China
      • The Third Affiliated Hospital of Sun Yat-sen University, Yuedong Hospital
  • Hebei
    • Cangzhou, Hebei, China
      • Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine
    • Qinhuangdao, Hebei, China
      • Peking University Third Hospital Qinhuangdao Hospital
    • Shijiazhuang, Hebei, China, 050051
      • Hebei Provincial People's Hospital
    • Tangshan, Hebei, China, 063000
      • Tangshan Worker's Hospital
      • Contact: Baoquan Lu; Phone Number: 13930565557; Email: balcom@163.com
      • Principal Investigator: Baoquan Lu, MD
  • Heilongjiang
    • Harbin, Heilongjiang, China
      • First Affiliated Hospital of Harbin Medical University
  • Henan
    • Zhengzhou, Henan, China
      • The First Affiliated Hospital of Zhengzhou University
  • Hubei
    • Shiyan, Hubei, China
      • Affiliated Taihe Hospital of Hubei University of Medicine
    • Wuhan, Hubei, China
      • Zhongnan Hospital of Wuhan University
  • Inner Mongolia
    • Baotou, Inner Mongolia, China, 014000
      • Baotou Central Hospital
  • Jiangsu
    • Nanjing, Jiangsu, China, 210000
      • Nanjing First Hospital
  • Shandong
    • Jining, Shandong, China, 272000
      • Jining First People's Hospital
    • Liaocheng, Shandong, China, 252000
      • Liaocheng People's Hospital
    • Qingdao, Shandong, China
      • The Affiliated Hospital of Qingdao University
    • Weifang, Shandong, China, 261000
      • Weifang People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria

1. Age 30 to 80 years, inclusive.
2. Acute ischemic stroke with symptom onset within 72 hours before screening, diagnosed on the basis of neurological deficits and CT or MRI findings.
3. National Institutes of Health Stroke Scale (NIHSS) score of 4 to 25 at hospital admission.
4. CTA, DSA, or MRA evidence that the culprit intracranial artery has atherosclerotic stenosis of 50% to 99%.

Exclusion Criteria

1. Intracranial arterial stenosis attributable to a nonatherosclerotic cause, such as arterial dissection, moyamoya disease, or systemic vasculitis.
2. Any definite source of cardioembolism, such as atrial fibrillation, a mechanical prosthetic heart valve, left ventricular thrombus, or patent foramen ovale.
3. Clinical and imaging findings suggesting that the index ischemic event is primarily attributable to cerebral small vessel disease.
4. Pre-stroke disability, defined as a modified Rankin Scale score of 2 or higher before the index ischemic event.
5. Extensive cerebral infarction on CT or MRI, such as an Alberta Stroke Program Early CT Score (ASPECTS) below 6 or an infarct volume of 70 mL or greater.
6. Previous stent implantation in the culprit vessel or planned stent implantation in the culprit vessel within 3 months after enrollment.
7. Any intracranial hemorrhage within 3 months before enrollment.
8. An intracranial tumor; or a cerebral aneurysm or arteriovenous malformation judged to require interventional treatment.
9. Severe active bleeding tendency or coagulation disorder.
10. Severe cardiac, hepatic, renal, or other major organ dysfunction.
11. Treatment with a PCSK9 monoclonal antibody inhibitor within 1 month before enrollment or with a PCSK9-targeting small interfering RNA therapy within 6 months before enrollment.
12. A definite contraindication to statin therapy or a history of statin intolerance.
13. Pregnant or breastfeeding, or planning to become pregnant during the study.
14. Current participation in another clinical trial.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Recaticimab plus standard therapy group; Recaticimab in combination with standard therapy	Drug: Recaticimab plus standard therapy; Recaticimab (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.
Placebo Comparator: Recaticimab's placebo in combination with standard therapy group; Recaticimab's placebo in combination with standard therapy	Drug: Recaticimab's placebo in combination with standard therapy; The 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."

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of participants with functional independence, defined as a modified Rankin Scale score of 0-2, at Day 90	The modified Rankin Scale (mRS) is a 7-category ordinal scale ranging from 0 (no symptoms) to 6 (death), with lower scores indicating better functional status. This outcome is the proportion of participants with an mRS score of 0-2, representing functional independence. Participants who die before the Day 90 assessment will be assigned an mRS score of 6. The assessment will be performed by trained assessors blinded to treatment allocation.	Day 90 (±7 days) after randomization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of participants with an excellent functional outcome, defined as an mRS score of 0-1, at Day 90	The mRS ranges from 0 (no symptoms) to 6 (death), with lower scores indicating better functional status. This outcome is the proportion of participants with an mRS score of 0-1, representing an excellent functional outcome. Participants who die before the assessment will be assigned an mRS score of 6.	Day 90 (±7 days) after randomization
Distribution of modified Rankin Scale (mRS) scores at Day 90	The ordinal distribution of mRS scores across all seven categories will be assessed. The mRS ranges from 0 (no symptoms) to 6 (death), with lower scores indicating better functional status. The outcome will evaluate a shift toward better functional outcomes across the full mRS distribution.	Day 90 (±7 days) after randomization
Incidence of any stroke through Day 90	Proportion of participants who experience an adjudicated stroke after randomization, including either ischemic stroke or hemorrhagic stroke. Suspected events will be reviewed by an independent Clinical Event Committee blinded to treatment allocation.	From randomization through Day 90
Incidence of ischemic stroke through Day 90	Proportion of participants who experience an adjudicated ischemic stroke after randomization. Ischemic stroke is defined as a new focal neurological injury attributable to cerebral ischemia, supported by clinical findings and/or imaging evidence of acute cerebral infarction, and not explained by a nonischemic cause. Events will be adjudicated by an independent blinded Clinical Event Committee.	From randomization through Day 90
Incidence of composite vascular events through Day 90	Proportion of participants who experience at least one component of the composite endpoint after randomization. The composite endpoint includes any stroke, myocardial infarction, or vascular death. Events will be adjudicated by an independent Clinical Event Committee blinded to treatment allocation.	From randomization through Day 90
Barthel Index score at Day 90	Activities of daily living will be assessed using the Barthel Index. The total score ranges from 0 to 100, with higher scores indicating greater independence in activities of daily living and better functional status.	Day 90 (±7 days) after randomization
Health-related quality of life assessed using the EQ-5D-5L at Day 90	Health-related quality of life will be assessed using the European Quality of Life 5-Dimension 5-Level instrument. The descriptive system assesses mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, with five levels of severity for each dimension. Overall self-rated health will also be assessed using the EQ visual analogue scale, ranging from 0 (worst imaginable health) to 100 (best imaginable health).	Day 90 (±7 days) after randomization
National Institutes of Health Stroke Scale score at Day 7 or hospital discharge	Neurological impairment will be assessed using the National Institutes of Health Stroke Scale (NIHSS). The NIHSS ranges from 0 to 42, with higher scores indicating greater neurological impairment.	Day 7 (±2 days) after randomization or at hospital discharge, whichever occurs first
Change from baseline in NIHSS score at Day 7 or hospital discharge	Change in NIHSS score will be calculated as the follow-up NIHSS score minus the baseline NIHSS score. The NIHSS ranges from 0 to 42, with higher scores indicating greater neurological impairment. A negative change indicates neurological improvement, whereas a positive change indicates neurological worsening.	From baseline to Day 7 (±2 days) after randomization or hospital discharge, whichever occurs first
Proportion of participants achieving an LDL-C level below 1.4 mmol/L at Day 7 or hospital discharge	Proportion of participants whose measured low-density lipoprotein cholesterol (LDL-C) concentration is below 1.4 mmol/L at the scheduled assessment.	Day 7 (±2 days) after randomization or at hospital discharge, whichever occurs first
Proportion of participants achieving an LDL-C level below 1.8 mmol/L at Day 7 or hospital discharge	Proportion of participants whose measured low-density lipoprotein cholesterol (LDL-C) concentration is below 1.8 mmol/L at the scheduled assessment.	Day 7 (±2 days) after randomization or at hospital discharge, whichever occurs first
Change from baseline in LDL-C level at Day 7 or hospital discharge	Change in LDL-C concentration will be calculated as the follow-up LDL-C value minus the baseline value and reported in mmol/L. A negative value indicates a reduction in LDL-C from baseline.	From baseline to Day 7 (±2 days) after randomization or hospital discharge, whichever occurs first

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in NIHSS score at 24 hours	Change in NIHSS score will be calculated as the 24-hour NIHSS score minus the baseline NIHSS score. The NIHSS ranges from 0 to 42, with higher scores indicating greater neurological impairment. A negative change indicates neurological improvement.	From baseline to 24 hours after randomization, with an allowable assessment window of -2 to +12 hours
Cerebral infarct volume at Day 7 or hospital discharge	Cerebral infarct volume will be quantified in milliliters using follow-up CT or MRI and assessed by a blinded core imaging laboratory. Lower infarct volumes indicate less extensive ischemic brain injury.	Day 7 (±2 days) after randomization or at hospital discharge, whichever occurs first
Cerebral perfusion parameters at Day 7 or hospital discharge	Prespecified quantitative cerebral perfusion parameters derived from CT perfusion or MR perfusion imaging will be assessed by a blinded core imaging laboratory.	Day 7 (±2 days) after randomization or at hospital discharge, whichever occurs first
Serum interleukin-6 concentration at Day 7 or hospital discharge	Serum interleukin-6 concentration will be measured as a marker of systemic inflammation. Higher concentrations indicate greater inflammatory activity. Testing will be performed according to the prespecified laboratory procedures.	Day 7 (±2 days) after randomization or at hospital discharge, whichever occurs first
High-sensitivity C-reactive protein concentration at Day 7 or hospital discharge	High-sensitivity C-reactive protein concentration will be measured as a marker of systemic inflammation. Higher concentrations indicate greater inflammatory activity.	Day 7 (±2 days) after randomization or at hospital discharge, whichever occurs first
Incidence of any stroke through 1 year	Proportion of participants who experience an adjudicated ischemic or hemorrhagic stroke after randomization. Events will be reviewed by an independent Clinical Event Committee blinded to treatment allocation.	From randomization through 1 year
Incidence of ischemic stroke through 1 year	Proportion of participants who experience an adjudicated ischemic stroke after randomization. Events will be reviewed by an independent Clinical Event Committee blinded to treatment allocation.	From randomization through 1 year
Incidence of composite vascular events through 1 year	Proportion of participants who experience at least one component of the composite endpoint, defined as any stroke, myocardial infarction, or vascular death. Events will be adjudicated by an independent blinded Clinical Event Committee.	From randomization through 1 year
Health-related quality of life assessed using the EQ-5D-5L at 1 year	Health-related quality of life will be assessed using the EQ-5D-5L descriptive system, covering mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Overall self-rated health will also be assessed using the EQ visual analogue scale ranging from 0 to 100, with higher scores indicating better perceived health.	At 1 year after randomization
Barthel Index score at 1 year	Activities of daily living will be assessed using the Barthel Index. The total score ranges from 0 to 100, with higher scores indicating greater independence and better functional status.	At 1 year after randomization
Incidence of moderate-to-severe symptomatic intracranial hemorrhage within 72 hours	Proportion of participants with symptomatic intracranial hemorrhage according to the modified Heidelberg criteria. The event must include imaging-confirmed intracranial hemorrhage, an increase of at least 4 points in the total NIHSS score compared with baseline or a previously recorded NIHSS score, and neurological deterioration that cannot be explained by a cause other than the intracranial hemorrhage. Qualifying hemorrhage types include parenchymal hematoma type 1 or 2, remote intracranial hemorrhage, subarachnoid hemorrhage, intraventricular hemorrhage, or subdural hemorrhage.	From randomization through 72 hours after randomization
All-cause mortality through Day 90	Proportion of participants who die from any cause after randomization and through Day 90. Death will be recorded as an mRS score of 6.	From randomization through Day 90
Incidence of adverse events through Day 90	Proportion of participants who experience at least one adverse event after administration of the study intervention. Adverse events will be recorded with respect to onset, duration, severity, relationship to the study intervention, action taken, and outcome, and will be coded using the Medical Dictionary for Regulatory Activities.	From administration of the study intervention through Day 90 after randomization
Incidence of serious adverse events through Day 90	Proportion of participants who experience at least one serious adverse event. A serious adverse event is an event that results in death, is life-threatening, requires inpatient hospitalization or prolongation of hospitalization, results in persistent or significant disability, causes a congenital anomaly or birth defect, or is considered an important medical event requiring intervention to prevent a serious outcome.	From administration of the study intervention through Day 90 after randomization

Collaborators and Investigators

• Sponsor: Peking Union Medical College Hospital
• Collaborators: Chinese PLA General Hospital; Huashan Hospital; Hebei General Hospital; The Affiliated Hospital of Qingdao University; Nanjing First Hospital, Nanjing Medical University; The First Affiliated Hospital of Zhengzhou University; Zhongnan Hospital; First Affiliated Hospital of Harbin Medical University; Taihe Hospital; Liaocheng People's Hospital; Weifang People's Hospital; Baotou Central Hospital; Chongqing General Hospital; Tangshan Worker's Hospital; Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine; Jining First People's Hospital

Publications and helpful links

General Publications

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• Hu X, Liu Y, Yuan W, Zhang Z, Li S, Cheng A, Yu Q, Guo H, Zou Y, Li M, Liu C, Xu Y, Xu W. Evolocumab Added to Statin Is Associated With Intracranial Atherosclerotic Plaque Regression Compared With Statin Alone. J Am Heart Assoc. 2025 Aug 19;14(16):e041251. doi: 10.1161/JAHA.124.041251. Epub 2025 Aug 18.
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• Luo Y, Yuan L, Liu Z, Dong W, Huang L, Liao A, Xie Y, Liu R, Lan W, Cai Y, Zhu W. Inhibition of PCSK9 Protects against Cerebral Ischemia-Reperfusion Injury via Attenuating Microcirculatory Dysfunction. Neurochem Res. 2024 Nov 16;50(1):10. doi: 10.1007/s11064-024-04272-z.
• Punch E, Klein J, Diaba-Nuhoho P, Morawietz H, Garelnabi M. Effects of PCSK9 Targeting: Alleviating Oxidation, Inflammation, and Atherosclerosis. J Am Heart Assoc. 2022 Feb;11(3):e023328. doi: 10.1161/JAHA.121.023328. Epub 2022 Jan 20.
• Park TH, Lee JK, Park MS, Park SS, Hong KS, Ryu WS, Kim DE, Park MS, Choi KH, Kim JT, Kang J, Kim BJ, Han MK, Lee J, Cha JK, Kim DH, Kim JG, Lee SJ, Cho YJ, Kwon JH, Shin DI, Yeo MJ, Sohn SI, Hong JH, Lee JS, Choi JC, Kim WJ, Lee BC, Yu KH, Oh MS, Park JM, Kang K, Lee KB, Lee J, Gorelick PB, Bae HJ. Neurologic deterioration in patients with acute ischemic stroke or transient ischemic attack. Neurology. 2020 Oct 20;95(16):e2178-e2191. doi: 10.1212/WNL.0000000000010603. Epub 2020 Aug 14.
• Glavan M, Liu J, Sampaio Silva G, Nguyen TN, Zhou J, Sestan N, Kimberly WT, Sheth KN. Endovascular thrombectomy for acute stroke: evolving eligibility criteria and adjunct therapies. Lancet Neurol. 2026 Jan;25(1):61-76. doi: 10.1016/S1474-4422(25)00356-4.
• 《中国卒中中心报告》编写组. 《中国卒中中心报告 2020》概要.中国脑血管病杂志. 2021;18(11):737-743.
• Writing Committee for the PEARL Investigators; Yang X, He X, Xu Y, Pan D, Li K, Chen Y, Zhu Y, Pan Y, Yi T, Zhang M, Peng H, Huang W, Li D, Feng J, Chen J, Lu W, Liao B, Xie Y, Liao B, Yang L, Tang L, Han B, Liu Y, Lin P, Chen J, Liang Y, Li D, Weng G, Huang H, Li H, Li C, Peng Z, Li H, He B, Xue R, Bao M, Sun H, Hou H, Zhou H, Xiao Y, Li J, Zhang W, Chen X, Yan W, Pi Y, Deng Z, Wang J, Xie D, Liu M, Li H, Peng Q, Fang W, Lin X, Chen Z, Li H, Lin Y, Lin Q, Xiao S, Miao Z, Wang D, Nguyen TN, Nogueira RG, Liu Y, Tang Y; PEARL investigators. Intra-Arterial Alteplase After Successful Endovascular Reperfusion in Acute Stroke: The PEARL Randomized Clinical Trial. JAMA. 2025 Oct 13;334(19):1728-39. doi: 10.1001/jama.2025.16876. Online ahead of print.

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2029

Study Registration Dates

• First Submitted: March 7, 2026
• First Submitted That Met QC Criteria: March 11, 2026
• First Posted (Actual): March 12, 2026

Study Record Updates

• Last Update Posted (Actual): July 15, 2026
• Last Update Submitted That Met QC Criteria: July 14, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: PCSK9 inhibitor; atherosclerotic plaque; Intracranial Atherosclerosis; intracranial artery stenosis; Recaticimab
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathological Conditions, Anatomical; Arteriosclerosis; Arterial Occlusive Diseases; Intracranial Arterial Diseases; Pathological Conditions, Signs and Symptoms; Plaque, Atherosclerotic; Intracranial Arteriosclerosis; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality of Health Care; Quality Indicators, Health Care; Standard of Care
• Other Study ID Numbers: 1-24PJ2600; 2024ZD0521605 (Other Grant/Funding Number: the Noncommunicable Chronic Diseases-National Science and Technology Major Project); 82025013 (Other Grant/Funding Number: the National Science Fund for Distinguished Young Scholars)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No