Acute Ischemic Stroke AISPhase 4PISTIAS-3NCT07466251
PCSK9 Inhibitor for Intracranial Atherosclerosis Related Acute Ischemic Stroke
A Phase 4 study testing Recaticimab plus standard therapy in people with Acute Ischemic Stroke AIS and Intracranial Atherosclerosis ICAS, run by Peking Union Medical College Hospital at 19 sites in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Acute Ischemic Stroke AIS, Intracranial Atherosclerosis ICAS, Atherosclerotic Plaque
- What is being tested?
- Recaticimab plus standard therapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,212 participants
- Where
- 19 sitesChina
- Study dates
- 1 Sep 2026to 31 Dec 2029
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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%.
Who cannot join
- 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.
- 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.
- Previous stent implantation in the culprit vessel or planned stent implantation in the culprit vessel within 3 months after enrollment.
Show all 14Show fewer
- Any intracranial hemorrhage within 3 months before enrollment.
- An intracranial tumor; or a cerebral aneurysm or arteriovenous malformation judged to require interventional treatment.
- Severe active bleeding tendency or coagulation disorder.
- Severe cardiac, hepatic, renal, or other major organ dysfunction.
- 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.
- A definite contraindication to statin therapy or a history of statin intolerance.
- Pregnant or breastfeeding, or planning to become pregnant during the study.
- Current participation in another clinical trial.
Trial locations and contacts
19 sites in 1 country. Contact the study team or a site near you to ask about taking part.
19 sites in 1 country
China19 sites
Baotou Central Hospital
Baotou, Inner Mongolia, 014000
Chinese PLA General Hospital
Beijing, Beijing Municipality, 100853
Shiwen Wu, MD, 86+13910238117, wu_shiwen@outlook.com
Shiwen Wu, MD
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, Beijing 100730
Beijing
Weihai Xu, MD, 86+13651147766, xuwh@pumch.cn
Weihai Xu, MD
Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine
Cangzhou, Hebei
Chongqing General Hospital
Chongqing
First Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang
Jining First People's Hospital
Jining, Shandong, 272000
Liaocheng People's Hospital
Liaocheng, Shandong, 252000
The Third Affiliated Hospital of Sun Yat-sen University, Yuedong Hospital
Meizhou, Guangdong
Nanjing First Hospital
Nanjing, Jiangsu, 210000
The Affiliated Hospital of Qingdao University
Qingdao, Shandong
Peking University Third Hospital Qinhuangdao Hospital
Qinhuangdao, Hebei
Huashan Hospital, Fudan University
Shanghai
Hebei Provincial People's Hospital
Shijiazhuang, Hebei, 050051
Affiliated Taihe Hospital of Hubei University of Medicine
Shiyan, Hubei
Tangshan Worker's Hospital
Tangshan, Hebei, 063000
Baoquan Lu, 13930565557, balcom@163.com
Baoquan Lu, MD
Weifang People's Hospital
Weifang, Shandong, 261000
Zhongnan Hospital of Wuhan University
Wuhan, Hubei
The first affiliated hospital of zhengzhou university
Zhengzhou, Henan
About this study
Official title: 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.
Read the 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.
- Being tested
- Recaticimab plus standard therapy, Recaticimab's placebo in combination with standard therapy
- Keywords
- Intracranial Atherosclerosis, intracranial artery stenosis, atherosclerotic plaque, PCSK9 inhibitor, Recaticimab
- Medical subject headings
- Plaque, Atherosclerotic, Intracranial Arteriosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recaticimab plus standard therapyDrug
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.
Recaticimab's placebo in combination with standard therapyDrug
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."
| Study group | Role | What they receive |
|---|---|---|
| Recaticimab plus standard therapy group | Experimental | Recaticimab in combination with standard therapy Receives: Drug: Recaticimab plus standard therapy |
| Recaticimab's placebo in combination with standard therapy group | Placebo comparator | Recaticimab's placebo in combination with standard therapy Receives: Drug: Recaticimab's placebo in combination with standard therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 90 (±7 days) after randomization
Secondary outcomes (12)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From baseline to Day 7 (±2 days) after randomization or hospital discharge, whichever occurs first
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2026
- Study start1 Sep 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (24)Papers the sponsor has linked to this study.
- Other trials for Acute Ischemic Stroke AISStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,212 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Chinese PLA General Hospital, Hebei General Hospital, Taihe Hospital, Weifang People's Hospital, Nanjing First Hospital, Nanjing Medical University, Baotou Central Hospital, Jining First People's Hospital, Liaocheng People's Hospital, Tangshan Worker's Hospital, Chongqing General Hospital, First Affiliated Hospital of Harbin Medical University, Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine, The First Affiliated Hospital of Zhengzhou University, The Affiliated Hospital of Qingdao University, Zhongnan Hospital, Huashan Hospital
- Responsible party
- Principal investigator, Wei-Hai Xu, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07466251
- Sponsor's protocol ID
- 1-24PJ2600
- Other IDs
- 2024ZD0521605, 82025013
- Acronym
- PISTIAS-3
- Status last verified
- Apr 2026
- First submitted
- 7 Mar 2026
- Last updated
- 15 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Zhao W, Li S, Li C, Wu C, Wang J, Xing L, Wan Y, Qin J, Xu Y, Wang R, Wen C, Wang A, Liu L, Wang J, Song H, Feng W, Ma Q, Ji X; TREND Investigators. Effects of Tirofiban on Neurological Deterioration in Patients With Acute Ischemic Stroke: A Randomized Clinical Trial. JAMA Neurol. 2024 Jun 1;81(6):594-602. doi: 10.1001/jamaneurol.2024.0868.
PubMed 38648030Tao C, Liu T, Cui T, Liu J, Li Z, Ren Y, Zhao X, Xie F, Li J, Wang H, Huang L, Li J, Wen J, Zeng J, Zhu J, Li Z, Li D, Hu X, Huang B, Wang J, Zhang C, Ye B, Hou Y, Gan Y, Sun H, Guan F, Shao Y, Liu Z, Ou Z, Fan S, Wang Y, Zhai H, Ni C, Wang H, Zhang C, Zhao Y, Wang G, Zhu Y, Li R, Sun J, Hu H, Cui J, Wang L, Zhang C, Song J, Jing X, Wang A, Wang J, Xu P, Qureshi AI, Nguyen TN, Nogueira RG, Saver JL, Hu W; ASSET-IT Investigators. Early Tirofiban Infusion after Intravenous Thrombolysis for Stroke. N Engl J Med. 2025 Sep 25;393(12):1191-1201. doi: 10.1056/NEJMoa2503678. Epub 2025 Jul 4.
PubMed 40616232Wang C, Gu H, Huo X, Yuan B, Li S, Xu J, Jiang Y, Jing J, Yao X, Li Z, Long F, Ma Z, Zhuang X, Xu L, Jin Y, Huang W, Zhang Y, Wen J, Wang A, Pan Y, Ye W, Yu W, Cheng A, Wang M, Dong Q, Xu A, Wang N, Yang Y, Meng X, Liu L, Zhao X, Li H, Miao Z, Li Z, Wang Y; TASTE-2 investigators. Edaravone dexborneol versus placebo on functional outcomes in patients with acute ischaemic stroke undergoing endovascular thrombectomy (TASTE-2): randomised controlled trial. BMJ. 2026 Jan 7;392:e086850. doi: 10.1136/bmj-2025-086850.
PubMed 41500725Writing 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.
PubMed 42262770Kim J, Hong U, Yoon CW, Bae JW, Rha JH, Park HK. PCSK9 inhibitor in acute ischemic stroke patient receiving mechanical thrombectomy: early outcomes and safety. Front Neurol. 2024 May 16;15:1375609. doi: 10.3389/fneur.2024.1375609. eCollection 2024.
PubMed 38817546Liu L, Chen W, Zhou H, Duan W, Li S, Huo X, Xu W, Huang L, Zheng H, Liu J, Liu H, Wei Y, Xu J, Wang Y; Chinese Stroke Association Stroke Council Guideline Writing Committee. Chinese Stroke Association guidelines for clinical management of cerebrovascular disorders: executive summary and 2019 update of clinical management of ischaemic cerebrovascular diseases. Stroke Vasc Neurol. 2020 Jun;5(2):159-176. doi: 10.1136/svn-2020-000378. Epub 2020 Jun 18.
PubMed 32561535Prabhakaran S, Gonzalez NR, Zachrison KS, Adeoye O, Alexandrov AW, Ansari SA, Chapman S, Czap AL, Dumitrascu OM, Ishida K, Jadhav AP, Johnson B, Johnston KC, Khatri P, Kimberly WT, Lee VH, Leslie-Mazwi TM, Mac Grory B, Madsen TE, Menon B, Mistry EA, Park S, Parker S, Perez de la Ossa N, Reeves M, Saiz T, Scott PA, Schwartzberg D, Sheth SA, Sporns PB, Times S, Tjoumakaris S, Wolfe SQ, Yaghi S; Peer Review Committee. 2026 Guideline for the Early Management of Patients With Acute Ischemic Stroke: A Guideline From the American Heart Association/American Stroke Association. Stroke. 2026 Aug;57(8):e316-e436. doi: 10.1161/STR.0000000000000513. Epub 2026 Jan 26.
PubMed 41582814Sun Y, Lv Q, Guo Y, Wang Z, Huang R, Gao X, Han Y, Yao Z, Zheng M, Luo S, Li Y, Gu X, Zhang Y, Wang J, Hong L, Ma X, Su G, Sheng J, Lai C, Shen A, Wang M, Zhang W, Wu S, Zheng Z, Li J, Zhong T, Wang Y, He L, Du X, Ma CS. Recaticimab as Add-On Therapy to Statins for Nonfamilial Hypercholesterolemia: The Randomized, Phase 3 REMAIN-2 Trial. J Am Coll Cardiol. 2024 Nov 12;84(20):2037-2047. doi: 10.1016/j.jacc.2024.09.012.
PubMed 39505412Xu M, Wang Z, Zhang Y, Liu Y, Huang R, Han X, Yao Z, Sun J, Tian F, Hu X, Ma L, Lai C, Zhang X, Sheng J, Han Q, Jin C, Luo L, Zhao R, Li L, Xu B, Yin D, Luo S, Ge X, Liu Z, Yang P, Huang Z, Li T, Feng W, Wu Y, Ling Z, Ma L, Lv C, Deng C, Wei W, Wang Y, Yan L, Ge J; REMAIN-1 Investigators. Recaticimab Monotherapy for Nonfamilial Hypercholesterolemia and Mixed Hyperlipemia: The Phase 3 REMAIN-1 Randomized Trial. J Am Coll Cardiol. 2024 Nov 12;84(20):2026-2036. doi: 10.1016/j.jacc.2024.07.035. Epub 2024 Oct 9.
PubMed 39387764Liu J, Li Y, Tian W, Cao H, Li X, Cheng L, Ji X, Liu J. Effects of PCSK9 inhibitor evolocumab on preventing early neurological deterioration in acute ischemic stroke patients with or without large artery atherosclerosis: a subgroup analysis of a randomized trial. BMC Neurol. 2025 Oct 17;25(1):431. doi: 10.1186/s12883-025-04434-8.
PubMed 41107765Wu L, Zhang B, Li C, Zhuang Z, Liu K, Chen H, Zhu S, Zhu J, Dai Z, Huang H, Jiang Y. PCSK9 inhibitors reduced early recurrent stroke in patients with symptomatic intracranial atherosclerotic stenosis. J Neurol Neurosurg Psychiatry. 2024 May 14;95(6):529-535. doi: 10.1136/jnnp-2023-332392.
PubMed 38212060Tian W, Cao H, Li X, Gong X, Yu X, Li D, Xie J, Bai Y, Zhang D, Li X, Xu P, Liu J, Zhang B, Ji X, Dong H. Adjunctive PCSK9 Inhibitor Evolocumab in the Prevention of Early Neurological Deterioration in Non-cardiogenic Acute Ischemic Stroke: A Multicenter, Prospective, Randomized, Open-Label, Clinical Trial. CNS Drugs. 2025 Feb;39(2):197-208. doi: 10.1007/s40263-024-01145-5. Epub 2025 Jan 5.
PubMed 39755915Zeng W, Zhou F, Zhao H, Wang Y, Chen J, Lu J, Zheng D, Kuang J, Yuan D, Zhou J, Shi C, Zhao X, Leng X, Yan B, Tan Z. Evaluation of Intensive Statins and Proprotein Convertase Subtilisin/Kexin Type 9 Inhibitors on Intracranial Artery Plaque Stability: A Prospective Single-Arm Study. J Am Heart Assoc. 2025 Jan 21;14(2):e035651. doi: 10.1161/JAHA.124.035651. Epub 2025 Jan 17.
PubMed 39818872Hu 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.
PubMed 40820974Jukema JW, Zijlstra LE, Bhatt DL, Bittner VA, Diaz R, Drexel H, Goodman SG, Kim YU, Pordy R, Reiner Z, Roe MT, Tse HF, Montenegro Valdovinos PC, White HD, Zeiher AM, Szarek M, Schwartz GG, Steg PG; ODYSSEY OUTCOMES Investigators. Effect of Alirocumab on Stroke in ODYSSEY OUTCOMES. Circulation. 2019 Dec 17;140(25):2054-2062. doi: 10.1161/CIRCULATIONAHA.119.043826. Epub 2019 Nov 11.
PubMed 31707788
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PCSK9 Inhibitor for Intracranial Atherosclerosis Related Acute Ischemic Stroke (PISTIAS-3): a Randomized, Double-blind, Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT07466251
- Acronym / sponsor ID
- PISTIAS-3 / 1-24PJ2600
- Keywords
- Intracranial Atherosclerosis, intracranial artery stenosis, atherosclerotic plaque, PCSK9 inhibitor, Recaticimab
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,212 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Collaborators
- Chinese PLA General Hospital, Hebei General Hospital, Taihe Hospital, Weifang People's Hospital, Nanjing First Hospital, Nanjing Medical University, Baotou Central Hospital, Jining First People's Hospital, Liaocheng People's Hospital, Tangshan Worker's Hospital, Chongqing General Hospital, First Affiliated Hospital of Harbin Medical University, Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine, The First Affiliated Hospital of Zhengzhou University, The Affiliated Hospital of Qingdao University, Zhongnan Hospital, Huashan Hospital
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 12 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Recaticimab plus standard therapy group | Experimental | Drug: Recaticimab plus standard therapyRecaticimab in combination with standard therapy |
| Recaticimab's placebo in combination with standard therapy group | Placebo comparator | Drug: Recaticimab's placebo in combination with standard therapyRecaticimab's placebo in combination with standard therapy |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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%.
Key exclusion criteria (14 listed)
- 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.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Recaticimab plus standard therapyRecaticimab (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. | Drug | Recaticimab plus standard therapy group |
| Recaticimab's placebo in combination with standard therapyThe 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." | Drug | Recaticimab's placebo in combination with standard therapy group |
Primary outcome
Proportion of participants with functional independence, defined as a modified Rankin Scale score of 0-2, at Day 90
Time frame: Day 90 (±7 days) after randomization
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.
12 secondary outcomes
Proportion of participants with an excellent functional outcome, defined as an mRS score of 0-1, at Day 90
Time frame: Day 90 (±7 days) after randomization
Distribution of modified Rankin Scale (mRS) scores at Day 90
Time frame: Day 90 (±7 days) after randomization
Incidence of any stroke through Day 90
Time frame: From randomization through Day 90
Incidence of ischemic stroke through Day 90
Time frame: From randomization through Day 90
Incidence of composite vascular events through Day 90
Time frame: From randomization through Day 90
Barthel Index score at Day 90
Time frame: Day 90 (±7 days) after randomization
Health-related quality of life assessed using the EQ-5D-5L at Day 90
Time frame: Day 90 (±7 days) after randomization
National Institutes of Health Stroke Scale score at Day 7 or hospital discharge
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: From baseline to Day 7 (±2 days) after randomization or hospital discharge, whichever occurs first
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2026.
- Results publication: PubMed 38648030Zhao W, Li S, Li C, Wu C, Wang J, Xing L, Wan Y, Qin J, Xu Y, Wang R, Wen C, Wang A, Liu L, Wang J, Song H, Feng W, Ma Q, Ji X; TREND Investigators. Effects of Tirofiban on Neurological Deterioration in Patients With Acute Ischemic Stroke: A Randomized Clinical Trial. JAMA Neurol. 2024 Jun 1;81(6):594-602. doi: 10.1001/jamaneurol.2024.0868.
- Results publication: PubMed 40616232Tao C, Liu T, Cui T, Liu J, Li Z, Ren Y, Zhao X, Xie F, Li J, Wang H, Huang L, Li J, Wen J, Zeng J, Zhu J, Li Z, Li D, Hu X, Huang B, Wang J, Zhang C, Ye B, Hou Y, Gan Y, Sun H, Guan F, Shao Y, Liu Z, Ou Z, Fan S, Wang Y, Zhai H, Ni C, Wang H, Zhang C, Zhao Y, Wang G, Zhu Y, Li R, Sun J, Hu H, Cui J, Wang L, Zhang C, Song J, Jing X, Wang A, Wang J, Xu P, Qureshi AI, Nguyen TN, Nogueira RG, Saver JL, Hu W; ASSET-IT Investigators. Early Tirofiban Infusion after Intravenous Thrombolysis for Stroke. N Engl J Med. 2025 Sep 25;393(12):1191-1201. doi: 10.1056/NEJMoa2503678. Epub 2025 Jul 4.
- Results publication: PubMed 41500725Wang C, Gu H, Huo X, Yuan B, Li S, Xu J, Jiang Y, Jing J, Yao X, Li Z, Long F, Ma Z, Zhuang X, Xu L, Jin Y, Huang W, Zhang Y, Wen J, Wang A, Pan Y, Ye W, Yu W, Cheng A, Wang M, Dong Q, Xu A, Wang N, Yang Y, Meng X, Liu L, Zhao X, Li H, Miao Z, Li Z, Wang Y; TASTE-2 investigators. Edaravone dexborneol versus placebo on functional outcomes in patients with acute ischaemic stroke undergoing endovascular thrombectomy (TASTE-2): randomised controlled trial. BMJ. 2026 Jan 7;392:e086850. doi: 10.1136/bmj-2025-086850.
- Results publication: PubMed 42262770Writing 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.
- Results publication: PubMed 38817546Kim J, Hong U, Yoon CW, Bae JW, Rha JH, Park HK. PCSK9 inhibitor in acute ischemic stroke patient receiving mechanical thrombectomy: early outcomes and safety. Front Neurol. 2024 May 16;15:1375609. doi: 10.3389/fneur.2024.1375609. eCollection 2024.
- Results publication: PubMed 32561535Liu L, Chen W, Zhou H, Duan W, Li S, Huo X, Xu W, Huang L, Zheng H, Liu J, Liu H, Wei Y, Xu J, Wang Y; Chinese Stroke Association Stroke Council Guideline Writing Committee. Chinese Stroke Association guidelines for clinical management of cerebrovascular disorders: executive summary and 2019 update of clinical management of ischaemic cerebrovascular diseases. Stroke Vasc Neurol. 2020 Jun;5(2):159-176. doi: 10.1136/svn-2020-000378. Epub 2020 Jun 18.
- Results publication: PubMed 41582814Prabhakaran S, Gonzalez NR, Zachrison KS, Adeoye O, Alexandrov AW, Ansari SA, Chapman S, Czap AL, Dumitrascu OM, Ishida K, Jadhav AP, Johnson B, Johnston KC, Khatri P, Kimberly WT, Lee VH, Leslie-Mazwi TM, Mac Grory B, Madsen TE, Menon B, Mistry EA, Park S, Parker S, Perez de la Ossa N, Reeves M, Saiz T, Scott PA, Schwartzberg D, Sheth SA, Sporns PB, Times S, Tjoumakaris S, Wolfe SQ, Yaghi S; Peer Review Committee. 2026 Guideline for the Early Management of Patients With Acute Ischemic Stroke: A Guideline From the American Heart Association/American Stroke Association. Stroke. 2026 Aug;57(8):e316-e436. doi: 10.1161/STR.0000000000000513. Epub 2026 Jan 26.
- Results publication: PubMed 39505412Sun Y, Lv Q, Guo Y, Wang Z, Huang R, Gao X, Han Y, Yao Z, Zheng M, Luo S, Li Y, Gu X, Zhang Y, Wang J, Hong L, Ma X, Su G, Sheng J, Lai C, Shen A, Wang M, Zhang W, Wu S, Zheng Z, Li J, Zhong T, Wang Y, He L, Du X, Ma CS. Recaticimab as Add-On Therapy to Statins for Nonfamilial Hypercholesterolemia: The Randomized, Phase 3 REMAIN-2 Trial. J Am Coll Cardiol. 2024 Nov 12;84(20):2037-2047. doi: 10.1016/j.jacc.2024.09.012.
- Results publication: PubMed 39387764Xu M, Wang Z, Zhang Y, Liu Y, Huang R, Han X, Yao Z, Sun J, Tian F, Hu X, Ma L, Lai C, Zhang X, Sheng J, Han Q, Jin C, Luo L, Zhao R, Li L, Xu B, Yin D, Luo S, Ge X, Liu Z, Yang P, Huang Z, Li T, Feng W, Wu Y, Ling Z, Ma L, Lv C, Deng C, Wei W, Wang Y, Yan L, Ge J; REMAIN-1 Investigators. Recaticimab Monotherapy for Nonfamilial Hypercholesterolemia and Mixed Hyperlipemia: The Phase 3 REMAIN-1 Randomized Trial. J Am Coll Cardiol. 2024 Nov 12;84(20):2026-2036. doi: 10.1016/j.jacc.2024.07.035. Epub 2024 Oct 9.
- Results publication: PubMed 41107765Liu J, Li Y, Tian W, Cao H, Li X, Cheng L, Ji X, Liu J. Effects of PCSK9 inhibitor evolocumab on preventing early neurological deterioration in acute ischemic stroke patients with or without large artery atherosclerosis: a subgroup analysis of a randomized trial. BMC Neurol. 2025 Oct 17;25(1):431. doi: 10.1186/s12883-025-04434-8.
- Results publication: PubMed 38212060Wu L, Zhang B, Li C, Zhuang Z, Liu K, Chen H, Zhu S, Zhu J, Dai Z, Huang H, Jiang Y. PCSK9 inhibitors reduced early recurrent stroke in patients with symptomatic intracranial atherosclerotic stenosis. J Neurol Neurosurg Psychiatry. 2024 May 14;95(6):529-535. doi: 10.1136/jnnp-2023-332392.
- Results publication: PubMed 39755915Tian W, Cao H, Li X, Gong X, Yu X, Li D, Xie J, Bai Y, Zhang D, Li X, Xu P, Liu J, Zhang B, Ji X, Dong H. Adjunctive PCSK9 Inhibitor Evolocumab in the Prevention of Early Neurological Deterioration in Non-cardiogenic Acute Ischemic Stroke: A Multicenter, Prospective, Randomized, Open-Label, Clinical Trial. CNS Drugs. 2025 Feb;39(2):197-208. doi: 10.1007/s40263-024-01145-5. Epub 2025 Jan 5.
- Individual participant dataSharing planned: Undecided
Related trials for Acute Ischemic Stroke AIS
Not yet recruitingPhase 2/3
A Phase II/III Clinical Study of SIM0811 in the Treatment of Acute Ischemic Stroke
Acute Ischemic Stroke AIS
Not yet recruitingPhase 3
Metformin in Acute Ischemic Stroke
Acute Ischemic Stroke
RecruitingObservational study
FORWARD: Functional Outcomes in Real-World Treatment And Revascularization of Non-dominant and Distal M2 Occlusions
Acute Ischemic Stroke, Acute Ischemic Stroke (AIS) Related to a Distal Occlusion
RecruitingPhase 2
A Study to Evaluate the Intracranial Arterial Recanalization With Multiple Doses of LT3001 Drug Product in AIS Participant
Acute Ischemic Stroke
RecruitingPhase 3
ACT-GLOBAL IA Thrombolysis(ACT-REACT-004)Domain Within the ACT-GLOBAL Adaptive Platform Trial-NCT06352632
Stroke, Acute Ischemic, Endovascular Thrombectomy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Recaticimab plus standard therapy in people with Acute Ischemic Stroke AIS and Intracranial Atherosclerosis ICAS, run by Peking Union Medical College Hospital at 19 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Weihai Xu, MD (86+13938912070, xuwh@pumch.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants with functional independence, defined as a modified Rankin Scale score of 0-2, at Day 90 (time frame: Day 90 (±7 days) after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07466251, which also lists 24 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2026.