A Phase 4 interventional study of Recaticimab and Statin and Statin in Intracranial Atherosclerosis, Intracranial Artery Stenosis and Atherosclerotic Plaque, sponsored by Peking Union Medical College Hospital. Recruiting at 19 sites in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-06-12.
Sponsored by Peking Union Medical College Hospital · Phase 4, Interventional, and Treatment
Among 44 studies in Intracranial Arteriosclerosis with a site in China — 28 open to participants now, 28 under way, 2 of them phase 3. Intracranial Arteriosclerosis · China.
Among the 44 studies in Intracranial Arteriosclerosis with a site in China, this one is the 10th largest by planned enrollment of the 27 interventional ones that give a count, is one of 3 that started in 2025, is one of 8 in phase 4, reaches primary completion later than 21 of the 27 other live ones, and was the 38th registered.
102 studies on the registry are indexed under Intracranial Arteriosclerosis; 48 are open to participants now.
Browse Intracranial Arteriosclerosis studies →28 of the 44 studies in Intracranial Arteriosclerosis with a site in China are open now. Recruiting first, the newest first:
Xuanwu Hospital, Beijing · Sites in China
Ages 18–80
Xuanwu Hospital, Beijing · Sites in China
Ages 18+ · Healthy volunteers
Qianfoshan Hospital · Sites in China
Ages 18–80
Fujian Medical University Union Hospital · Sites in China
Ages 18+
Sino Medical Sciences Technology Inc. · Sites in China
Ages 18–85
A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →
Of the 28 Intracranial Arteriosclerosis studies recruiting now, 11 (39%) set no upper age limit and 1 (4%) stops at 75 or younger; none take children under 18; 2 take healthy volunteers.
This study: 18 Years to 80 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
44 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 2 1 · Phase 3 3 · Phase 4 8
First in 2007; this study’s year is marked. 3 started in 2025.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 300 is above the median of 194 across 61 interventional studies indexed under Intracranial Arteriosclerosis.
Median enrollment 200 across the 27 interventional studies, 300 across the 17 observational. Of the 7 that completed or were terminated, 0 (0%) have results posted.
This tab as a report to print or save as PDF → With an account.
11 of 44 have an industry lead sponsor. The 10 most frequent:
Peking Union Medical College Hospital is the lead sponsor of 1,155 studies on the registry; 475 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Peking Union Medical College Hospital has 3 studies filed under Intracranial Arteriosclerosis — fewer than ten, so there is no comparison to draw.
6 of the studies in Intracranial Arteriosclerosis with a site in China that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06925971Phase 3MicroPort NeuroTech Co., Ltd.A Randomized Trial of the Rapamycin Target Eluting Stent for the Treatment of Symptomatic Cerebral Artery Atherosclerotic Disease（TARGET-DREAM） | 2027-10-01 |
| NCT07445581Jinggang Xia, MDTanhuo Decoction for Acute Coronary Syndrome With Cerebral Atherosclerosis in Elderly Patients | 2026-12-31 |
| NCT06881420Fujian Medical University Union HospitalBASIS Technique for Endovascular Therapy of Acute Large Vessel Occlusion Strokes Due to Intracranial Atherosclerotic Disease | 2026-12-31 |
| NCT05550077jiaoliqunOptical Coherence Tomography for Intracranial Atherosclerotic Stenosis | 2026-12-31 |
| NCT07927569Qianfoshan HospitalIntegrated PET/MR Assessment of Brain Recovery After Recanalization of Non-Acute Atherosclerotic MCA Occlusion | 2027-01-01 |
Add all 6 to your calendar (.ics) → With an account.
Among the 44 studies in Intracranial Arteriosclerosis with a site in China, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This is a prospective, multicenter, open-label, blinded-endpoint, randomized controlled trial designed to evaluate the efficacy and safety of PCSK9 inhibitor combined with statin therapy compared to statin monotherapy in reversing asymptomatic intracranial atherosclerosis, assessed using high-resolution magnetic resonance imaging of the intracranial vessel walls.
Intracranial atherosclerotic stenosis (ICAS) is a leading cause of ischemic stroke worldwide, accounting for approximately 10-20% of all ischemic strokes in Europe and the United States, and up to 50% in Asian populations. While evidence-based management strategies for symptomatic ICAS have been progressively established over the past decades, asymptomatic ICAS - representing an earlier-stage, broader, high-risk population - has long been under-recognized and under-studied. Asymptomatic ICAS (stenosis > 50%) has a reported prevalence of approximately 6%-13%, and is associated with a substantially increased risk of future cerebrovascular events. Moreover, accumulating evidence has demonstrated that asymptomatic ICAS is independently associated with cognitive decline and incident dementia, likely due to chronic downstream hypo-perfusion and cumulative ischemic injury. Therefore, the development of systematic, evidence-based, and precision prevention strategies for asymptomatic ICAS is essential for reducing the overall disease burden attributable to ICAS-related cerebrovascular and neurodegenerative disorders.
It is well established that dysregulation of lipid metabolism is a fundamental pathophysiological mechanism driving the initiation and progression of ICAS, and low-density lipoprotein cholesterol (LDL-C) has been consistently identified as the primary therapeutic target for atherosclerotic cardiovascular disease and for the prevention of ischemic stroke. Existing evidence has demonstrated that reductions in lipid levels and the regression of atherosclerotic plaques are closely associated with a decreased risk of cardiovascular events. Statin therapy remains the cornerstone of lipid-lowering treatment, capable of stabilizing atherosclerotic plaques and improving clinical outcomes. However, limitations of statins such as the plateau effect of LDL-C reduction, intolerance, and poor adherence in certain patients necessitate alternative or adjunctive lipid-lowering strategies. Proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors, human monoclonal antibodies targeting PCSK9, have shown excellent efficacy in achieving intensive LDL-C reduction and have been extensively validated for safety in large clinical trials. Recently published studies have highlighted the potential of PCSK9 inhibitors in plaque regression and stabilization beyond coronary and carotid arteries. The SLICE-CEA CardioLink-8 trial demonstrated that adding evolocumab to moderate- or high-intensity statin therapy for 6 months significantly reduced the lipid-rich necrotic core in asymptomatic high-risk carotid plaques. Similarly, the ARCHITECT study revealed that alirocumab in combination with high-intensity statin therapy led to significant regression of coronary plaque burden and enhanced plaque stability in asymptomatic patients over a 78-week period. Several observational studies have indicated that intensive lipid-lowering therapy may reverse asymptomatic ICAS. However, to date, no clinical trials have specifically evaluated the efficacy and safety of PCSK9 inhibitors in addition to statin therapy in patients with asymptomatic ICAS. This represents a critical evidence gap, as these patients constitute a broader, earlier, and high-risk population for cerebrovascular events.
The PISTIAS-2 is an investigator-initiated, multicentre, prospective, open-label, blinded end-point, randomized controlled trial designed to evaluate the efficacy and safety of PCSK9 inhibitor combined with statin therapy compared to statin monotherapy in patients with asymptomatic ICAS. Patients aged 18 to 80 years with asymptomatic ICAS, defined as 50% to 99% stenosis in at least one major intracranial artery without a prior history of ischemic stroke or transient ischemic attack, will be enrolled for 24-week treatment. Eligible participants will be centrally randomized into two groups: (1) Experimental group [PCSK9 inhibitor combined with statin therapy]: Recaticimab 450 mg every 12 weeks combined with rosuvastatin 10 mg q.n. or atorvastatin 20 mg q.n. (2) Control group [Statin alone]: Rosuvastatin 10 mg q.n. or atorvastatin 20 mg q.n. Considering inter-individual variability in lipid-lowering response, ezetimibe 10 mg once daily is permitted at the discretion of the study physician based on the predefined criteria: (1) patients already receiving statin therapy prior to enrollment whose LDL-C remains above 2.6 mmol/L, and (2) statin-naïve patients whose LDL-C exceeds 2.6 mmol/L at the 12-week lipid profile reassessment. In this trial, we employed a novel PCSK9 inhibitor, Recaticimab, a humanized IgG1 monoclonal antibody engineered with a strategic YTE mutation in its Fc region, which enhances its affinity for the neonatal Fc receptor (FcRn). This modification reduces FcRn-mediated antibody catabolism, thereby extending the half-life of Recaticimab and enabling a prolonged dosing interval of up to 12 weeks.
The primary outcome is the change in intracranial plaque burden from baseline to week 24, measured by high-resolution magnetic resonance imaging (HR-MRI).The key secondary outcomes include: change in stenosis degree from baseline to week 24, time from randomization to the first-ever ischemic stroke or transient ischemic attack, and change in plasma marker glial fibrillary acidic protein(GFAP) and neurofilament light (NfL). Other secondary outcomes include: time from randomization to the occurrence of major adverse cardiovascular events, new-onset silent cerebral infarction, percentage of patients who achieved LDL-C goal at week 24, percentage change in LDL-C relative to baseline, and change in plasma marker Aβ40, Aβ42, Aβ42/Aβ40. In addition, several pre-specified exploratory outcomes have been defined for this study. Details are provided in the "Outcome Measures" section.
After the 24-week treatment period, an extended prospective follow-up (clinical or telephone follow-up) will continue for more than one year to document long-term effects.The sample size is calculated based on the primary outcome and a total of 300 participants are anticipated. An interim analysis will be conducted when 50% of the participants (i.e., 150 subjects) have completed the 24-week follow-up with HR-MRI. An independent Data Safety Monitoring Board will oversee the overall conduct of the trial.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Recaticimab (450mg every 12 weeks subcutaneously) combined with rosuvastatin 10mg qn or atorvastatin 20mg qn
Drug: Recaticimab and Statin
Rosuvastatin 10mg qn or atorvastatin 20mg qn
Drug: Statin
Drug pages: Recaticimab · Statins
Recaticimab (450mg every 12 weeks subcutaneously) combined with rosuvastatin 10mg qn or atorvastatin 20mg qn
Rosuvastatin 10mg qn or atorvastatin 20mg qn
Change in plaque burden from baseline to week 24
Intracranial plaque burden was assessed at maximum stenosis site by high-resolution magnetic resonance imaging, performed at baseline and the end of the treatment period (24 \[±1\] week) on the same machine. The plaque burden is calculated according to the following formula: plaque burden = \[(vessel wall cross-sectional area - lumen cross-sectional area ) / vessel wall cross-sectional area\] ×100%. The outcome will be centrally assessed by an independent core imaging laboratory blinded to treatment allocation according to a predefined imaging analysis protocol.
Time frame: From baselie to the end of treatment at 24 weeks
Change in stenosis degree from baseline to week 24
The degree of stenosis is calculated according to the Warfarin-Aspirin Symptomatic Intracranial Disease (WASID) criteria using the formula: \[1-(Dstenosis/Dnormal)\]×100%. Dstenosis represents the vessel diameter at the most stenotic site of the intracranial artery, and Dnormal represents the normal vessel diameter at a reference site.
Time frame: From baseline to the end of treatment at 24 weeks
Time from randomization to the first-ever ischemic stroke or transient ischemic attack
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. Transient Ischemic Attack (TIA): Defined as a sudden onset of focal neurological deficit due to cerebral or retinal ischemia, which completely resolves within 24 hours. Imaging (CT or MRI) must show no evidence of a new cerebral infarction. Other non-ischemic causes, such as brain infection, trauma, tumor, epilepsy, severe metabolic disorders, or progressive neurological diseases, must be excluded.
Time frame: From baseline to the end of treatment at 24 weeks
Change in plasma marker glial fibrillary acidic protein(GFAP)
Change in plasma marker glial fibrillary acidic protein(GFAP) quantified using the Single Molecule Array platform from baseline to the end of treatment at 24 weeks
Time frame: From baseline to the end of treatment at 24 weeks
Change in plasma marker neurofilament light(NfL)
Change in plasma marker Neurofilament light(NfL) quantified using the Single Molecule Array platform from baseline to the end of treatment at 24 weeks
Time frame: From baseline to the end of treatment at 24 weeks
Time from randomization to the occurrence of major adverse cardiovascular events
Composite major adverse cardiovascular endpoints includes ischemic stroke, myocardial infarction, and cardiovascular mortality as a cluster
Time frame: From baseline to the end of treatment at 24 weeks
Silent cerebral infarction
New-onset silent cerebral infarction is defined as an imaging-detected infarct without acute clinical symptoms
Time frame: at 24 weeks of treatment
Percentage of patients who achieved LDL-C goal at week 24
Percentage of patients achieving the LDL-C target at week 24 of treatment, defined as LDL-C \< 1.8 mmol/L or LDL-C \< 2.6 mmol/L based on ASCVD risk assessment.
Time frame: at 24 weeks of treatment
Percentage change in LDL-C relative to baseline
Percentage change in LDL-C level at 24 weeks of treatment relative to baseline
Time frame: From baseline to the end of treatment at 24 weeks
Change in Plasma marker Aβ42/Aβ40
Change in plasma markers Aβ42/Aβ40 from baseline to the end of treatment at 24 weeks
Time frame: From baseline to the end of treatment at 24 weeks
Time from randomization to the time of the first occurrence of transient ischemic attack
Transient Ischemic Attack (TIA): Defined as a sudden onset of focal neurological deficit due to cerebral or retinal ischemia, which completely resolves within 24 hours. Imaging (CT or MRI) must show no evidence of a new cerebral infarction. Other non-ischemic causes, such as brain infection, trauma, tumor, epilepsy, severe metabolic disorders, or progressive neurological diseases, must be excluded.
Time frame: From baseline to the end of treatment at 24 weeks
Time from randomization to the time of the first occurrence of 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 baseline to the end of treatment at 24 weeks
Time from randomization to the time of the occurrence of any stroke
Any stroke includes ischemic and hemorrhagic stroke
Time frame: From baseline to the end of treatment at 24 weeks
Time from randomization to the time of the occurrence of myocardial infarction
Time from randomization to the time of the occurrence of myocardial infarction
Time frame: From baseline to the end of treatment at 24 weeks
Time from randomization to the time of the occurrence of vascular death
Time from randomization to the time of the occurrence of vascular death
Time frame: From baseline to the end of treatment at 24 weeks
Time from randomization to the time of the occurrence of any death
All-cause mortality will be calculated between two arms
Time frame: From baseline to the end of treatment at 24 weeks
Changes in cognitive scale scores
Cognitive function will be evaluated via MMSE and MOCA at baseline and week 24
Time frame: From baseline to the end of treatment at 24 weeks
Changes in traditional lipid parameters
Changes in traditional lipid profiles, especially total cholesterol (TC), triglycerides (TG) and HDL-C.
Time frame: From baseline to the end of treatment at 24 weeks
Change in Lipoprotein (a) level
Non-traditional lipid parameters such as Lipoprotein (a) level will be detected at baseline and week 24
Time frame: From baseline to the end of treatment at 24 weeks
Visit-to-visit lipid variability of LDL-C
Lipid variability during the treatment period, which can be evaluated by the following indicators: coefficient of variation (CV), standard deviation (SD), variability independent of the mean (VIM), average real variability (ARV).
Time frame: From baseline to the end of treatment at 24 weeks
Change in high-sensitivity C-reactive protein
Inflammatory markers such as high-sensitivity C-reactive protein (hs-CRP) will be detected at baseline and week 24
Time frame: From baseline to the end of treatment at 24 weeks
Change in plasma marker pTau217
Markers of neurological disorders such asplasma marker pTau217 will be detected at baseline and week 24
Time frame: From baseline to the end of treatment at 24 weeks
Changes in DNA methylation status of peripheral blood cells
DNA methylation, particularly RNF213, an important epigenetic factor, may play a role in the progression of ICAS.
Time frame: From baseline to the end of treatment at 24 weeks
Changes in Senescence-Associated Secretory Phenotype
Previous studies have shown that lipid-lowering has an obvious scavenging effect on senescent cells. Senescence associated β-galactosidase, SA-β-gal, is thought to be a sign of aging
Time frame: From baseline to the end of treatment at 24 weeks
Change in length of plaque
length of plaque was evaluated by high-resolution MRI at baseline and week 24
Time frame: From baseline to the end of treatment at 24 weeks
Change in plaque maximum thickness
the maximum thickness of plaque was evaluated by high-resolution MRI at baseline and week 24
Time frame: From baseline to the end of treatment at 24 weeks
Change in the outer-wall boundary area at the maximal stenotic site
the outer-wall boundary area at the maximal stenotic site was evaluated by high-resolution MRI at baseline and week 24
Time frame: From baseline to the end of treatment at 24 weeks
Change in remodeling index of the plaque
Remodeling index of the plaque is calculated by the ratio of the diameter of the lumen at the most severe lesion to the diameter of the proximal reference lumen, positive remodeling defined as remodeling index \> 1.1
Time frame: From baseline to the end of treatment at 24 weeks
Change in plaque enhancement
plaque enhancement will be detected via contrast enhanced high- resolution MRI
Time frame: From baseline to the end of treatment at 24 weeks
Change in brain volume
Total brain volume will be evaluated by MRI 3D-T1WI at baseline and week 24
Time frame: From baseline to the end of treatment at 24 weeks
Change in cortical thickness
The thickness and surface area of cerebral cortex in all and different brain regions were quantitatively determined based on MRI
Time frame: From baseline to the end of treatment at 24 weeks
Change in cerebral small vessel disease burden
cerebral small vessel disease burden were quantitatively determined based on MRI at baseline and week 24
Time frame: From baseline to the end of treatment at 24 weeks
Change in white matter hyperintensity
White matter hyperintensity (WMH) in all and different brain regions were quantitatively determined based on MRI
Time frame: From baseline to the end of treatment at 24 weeks
Change in collateral circulation status
Collateral circulation status will be assessed using standardized imaging-based grading scales to evaluate the extent and quality of collateral blood flow.
Time frame: From baseline to the end of treatment at 24 weeks
Adverse events
An Adverse Event (AE) is any untoward medical occurrence in clinical trial subject administered a pharmaceutical product and which does not necessarily have a causal relationship with the treatment.
Time frame: From baseline to the end of treatment at 24 weeks
Serious Adverse Events
A Serious Adverse Event (SAE) is any untoward medical occurrence that, at any dose: (1) results in death; (2) is life-threatening; (3) requires inpatient hospitalization or prolongation of existing hospitalization; (4)results in persistent or significant disability/incapacity; (5) is a congenital anomaly/birth defect; (6) is otherwise considered medically significant by the investigator.
Time frame: From baseline to the end of treatment at 24 weeks
Plan to share: Undecided
Started Nov 2025 (actual). Primary completion is estimated for Dec 2027, 25 months after the start.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
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Studies of the drugs tested here: Recaticimab · Statins
Intracranial Arteriosclerosis →
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