Stroke and Vascular Neurology最新文献

{"title":"Implications of MMP-12 in the pathophysiology of ischaemic stroke.","authors":"Krishna Kumar Veeravalli","doi":"10.1136/svn-2023-002363","DOIUrl":"10.1136/svn-2023-002363","url":null,"abstract":"<p><p>This article focuses on the emerging role of matrix metalloproteinase-12 (MMP-12) in ischaemic stroke (IS). MMP-12 expression in the brain increases dramatically in animal models of IS, and its suppression reduces brain damage and promotes neurological, sensorimotor and cognitive functional outcomes. Thus, MMP-12 could represent a potential target for the management of IS. This article provides an overview of MMP-12 upregulation in the brain following IS, its deleterious role in the post-stroke pathogenesis (blood-brain barrier disruption, inflammation, apoptosis and demyelination), possible molecular interactions and mechanistic insights, its involvement in post-ischaemic functional deficits and recovery as well as the limitations, perspectives, challenges and future directions for further research. Prior to testing any MMP-12-targeted therapy in patients with acute IS, additional research is needed to establish the effectiveness of MMP-12 suppression against IS in older animals and in animals with comorbidities. This article also examines the clinical implications of suppressing MMP-12 alone or in combination with MMP-9 for extending the currently limited tissue plasminogen activator therapy time window. Targeting of MMP-12 is expected to have a profound influence on the therapeutic management of IS in the future.</p>","PeriodicalId":22021,"journal":{"name":"Stroke and Vascular Neurology","volume":" ","pages":"97-107"},"PeriodicalIF":5.9,"publicationDate":"2024-04-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11103161/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9662017","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Randomised study of bailout intracranial angioplasty following thrombectomy for acute large vessel occlusion (ANGEL-REBOOT): protocol of a multicentre randomised controlled trial.","authors":"Feng Gao, Xu Tong, Baixue Jia, Ming Yang, Yuesong Pan, Zeguang Ren, William Scott Burgin, Liping Liu, Xingquan Zhao, Yilong Wang, Yongjun Wang, Zhongrong Miao","doi":"10.1136/svn-2023-002433","DOIUrl":"10.1136/svn-2023-002433","url":null,"abstract":"<p><strong>Rationale: </strong>Unsuccessful thrombectomy of acute large vessel occlusions (LVOs) has been associated with unfavourable outcomes. Multiple randomised controlled trials (RCTs) have reported a failure rate of 12%-41% for thrombectomy procedures. Various factors contribute to failed thrombectomy, including technical difficulties in accessing the occlusion, unsuccessful thrombus retrieval, thrombotic reocclusion and pre-existing intracranial atherosclerotic stenosis. Although some studies have explored balloon dilation or permanent stenting as rescue intracranial angioplasty for failed thrombectomy in individual cases, there is currently no evidence from RCTs on this specific topic.</p><p><strong>Aim: </strong>To evaluate the potential superiority of bailout angioplasty over standard treatment in cases of unsuccessful recanalisation (eTICI 0 to 2a) or residual severe stenosis (>70%) after thrombectomy in acute LVO patients within 24 hours of stroke onset.</p><p><strong>Design: </strong>This study is a multicentre, prospective, randomised, controlled clinical trial designed by investigators. It compares bailout angioplasty with standard therapy and follows an open-label treatment approach while maintaining a blinded outcome assessment (PROBE design). Our objective is to allocate 348 patients in a 1:1 ratio to either receive bailout angioplasty as an intervention or standard therapy as a control, following unsuccessful thrombectomy.</p><p><strong>Outcome: </strong>The main measure of interest is the modified Rankin Scale (mRS) Score, which will be assessed in a blinded manner at 90 (±14) days following randomisation. The primary effect size will be determined using ordered logistic regression to calculate the common OR, representing the shift on the six-category mRS Scale at the 90-day mark. Additionally, the safety outcomes will be evaluated, including symptomatic intracranial haemorrhage within 18-36 hours, severe procedure-related complications and mortality within 90 (±14) days, among others.</p><p><strong>Discussion: </strong>The ANGEL-REBOOT study aims to generate substantial evidence regarding the efficacy and safety of bailout intracranial angioplasty as a treatment option for patients with LVO who have experienced unsuccessful thrombectomy.</p><p><strong>Trial registration number: </strong>NCT05122286.</p>","PeriodicalId":22021,"journal":{"name":"Stroke and Vascular Neurology","volume":" ","pages":"181-188"},"PeriodicalIF":5.9,"publicationDate":"2024-04-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11103159/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9846663","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Penumbra-targeted CircOGDH siRNA-loaded nanoparticles alleviate neuronal apoptosis in focal brain ischaemia.","authors":"Yanfang Liu, Tianyuan Zhang, Xing Zou, Zhongwen Yuan, Yufeng Li, Jiankun Zang, Niu He, Lizhen He, Anding Xu, Dan Lu","doi":"10.1136/svn-2022-002009","DOIUrl":"10.1136/svn-2022-002009","url":null,"abstract":"<p><strong>Background: </strong>Nanoparticles (NPs) are a class of substances that can be loaded with therapeutic agents delivered to specific areas. In our earlier research, we identified a neuron-derived circular RNA (circRNA), circular oxoglutarate dehydrogenase (CircOGDH), as a promising therapeutic target for acute ischaemic stroke. This study dedicated to explore a prospective preliminary strategy of CircOGDH-based NP delivered to the ischaemic penumbra region in middle cerebral artery occlusion/reperfusion (MCAO/R) mice.</p><p><strong>Methods: </strong>Immunofluorescence in primary cortex neurons and in vivo fluorescence imaging revealed endocytosis of Poly(lactide-co-glycolide) (PLGA) poly amidoamine(PAMAM)@CircOGDH small interfering RNA (siRNA) NPs. Western blotting analysis and CCK8 assay were performed to evaluate the apoptotic level in ischaemic neurons treated with PLGA-PAMAM@CircOGDH siRNA NPs. Quantitative reverse transcription PCR experiments, mice behaviour test, T2 MRI analysis, Nissl and TdT-mediated dUTP nick end labeling (TUNEL) co-staining were performed to evaluate the apoptosis level of ischaemic penumbra neurons in MCAO/R mice. Biosafety evaluation of NPs in MCAO/R mice was detected by blood routine examination, liver and kidney function examination and HE staining.</p><p><strong>Results: </strong>PLGA-PAMAM@CircOGDH siRNA NPs were successfully assembled. Endocytosis of PLGA-PAMAM@CircOGDH siRNA NPs in ischaemic neurons alleviated neuronal apoptotic level in vitro and in vivo. Furthermore, mice behaviour test showed that the neurological defects of MCAO/R mice were significantly alleviated after the tail injection of PLGA-PAMAM@CircOGDH siRNA NPs, and no toxic effects were observed.</p><p><strong>Conclusion: </strong>In conclusion, our results suggest that PLGA-PAMAM@CircOGDH siRNA NPs can be delivered to the ischaemic penumbra region and alleviate neuron apoptosis in MCAO/R mice and in ischaemic neurons; therefore, our study provides a desirable approach for using circRNA-based NPs for the treatment of ischaemic stroke.</p>","PeriodicalId":22021,"journal":{"name":"Stroke and Vascular Neurology","volume":" ","pages":"134-144"},"PeriodicalIF":5.9,"publicationDate":"2024-04-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11103160/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9641293","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Intelligent cholinergic white matter pathways algorithm based on U-net reflects cognitive impairment in patients with silent cerebrovascular disease","authors":"Beini Fei, Yu Cheng, Ying Liu, Guangzheng Zhang, Anyan Ge, Junyi Luo, Shan Wu, He Wang, Jing Ding, Xin Wang","doi":"10.1136/svn-2023-002976","DOIUrl":"https://doi.org/10.1136/svn-2023-002976","url":null,"abstract":"Background and objective The injury of the cholinergic white matter pathway underlies cognition decline in patients with silent cerebrovascular disease (SCD) with white matter hyperintensities (WMH) of vascular origin. However, the evaluation of the cholinergic white matter pathway is complex with poor consistency. We established an intelligent algorithm to evaluate WMH in the cholinergic pathway. Methods Patients with SCD with WMH of vascular origin were enrolled. The Cholinergic Pathways Hyperintensities Scale (CHIPS) was used to measure cholinergic white matter pathway impairment. The intelligent algorithm used a deep learning model based on convolutional neural networks to achieve WMH segmentation and CHIPS scoring. The diagnostic value of the intelligent algorithm for moderate-to-severe cholinergic pathway injury was calculated. The correlation between the WMH in the cholinergic pathway and cognitive function was analysed. Results A number of 464 patients with SCD were enrolled in internal training and test set. The algorithm was validated using data from an external cohort comprising 100 patients with SCD. The sensitivity, specificity and area under the curve of the intelligent algorithm to assess moderate and severe cholinergic white matter pathway injury were 91.7%, 87.3%, 0.903 (95% CI 0.861 to 0.952) and 86.5%, 81.3%, 0.868 (95% CI 0.819 to 0.921) for the internal test set and external validation set. for the. The general cognitive function, execution function and attention showed significant differences among the three groups of different CHIPS score (all p<0.05). Discussion We have established the first intelligent algorithm to evaluate the cholinergic white matter pathway with good accuracy compared with the gold standard. It helps more easily assess the cognitive function in patients with SCD. Data are available upon reasonable request.","PeriodicalId":22021,"journal":{"name":"Stroke and Vascular Neurology","volume":"3 1","pages":""},"PeriodicalIF":5.9,"publicationDate":"2024-04-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140565465","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Design of trials in lacunar stroke and cerebral small vessel disease: review and experience with the LACunar Intervention Trial 2 (LACI-2)","authors":"Gordon Blair, Jason P Appleton, Iris Mhlanga, Lisa J Woodhouse, Fergus Doubal, Philip M Bath, Joanna M Wardlaw","doi":"10.1136/svn-2023-003022","DOIUrl":"https://doi.org/10.1136/svn-2023-003022","url":null,"abstract":"Cerebral small vessel disease (cSVD) causes lacunar stroke (25% of ischaemic strokes), haemorrhage, dementia, physical frailty, or is ‘covert’, but has no specific treatment. Uncertainties about the design of clinical trials in cSVD, which patients to include or outcomes to assess, may have delayed progress. Based on experience in recent cSVD trials, we reviewed ways to facilitate future trials in patients with cSVD. We assessed the literature and the LACunar Intervention Trial 2 (LACI-2) for data to inform choice of Participant, Intervention, Comparator, Outcome, including clinical versus intermediary endpoints, potential interventions, effect of outcome on missing data, methods to aid retention and reduce data loss. We modelled risk of missing outcomes by baseline prognostic variables in LACI-2 using binary logistic regression. Imaging versus clinical outcomes led to larger proportions of missing data. We present reasons for and against broad versus narrow entry criteria. We identified numerous repurposable drugs with relevant modes of action to test in various cSVD subtypes. Cognitive impairment is the most common clinical outcome after lacunar ischaemic stroke but was missing more frequently than dependency, quality of life or vascular events in LACI-2. Assessing cognitive status using Diagnostic and Statistical Manual for Mental Disorders Fifth Edition can use cognitive data from multiple sources and may help reduce data losses. Trials in patients with all cSVD subtypes are urgently needed and should use broad entry criteria and clinical outcomes and focus on ways to maximise collection of cognitive outcomes to avoid missing data.","PeriodicalId":22021,"journal":{"name":"Stroke and Vascular Neurology","volume":"239 1","pages":""},"PeriodicalIF":5.9,"publicationDate":"2024-04-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140565177","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Intra-arterial tenecteplase during thrombectomy for acute stroke (BRETIS-TNK II): rationale and design.","authors":"Zi-Ai Zhao, Jing Qiu, Wei Li, Thanh Nguyen, Shouchun Wang, Huaizhang Shi, Ming Wei, Feng Wang, Di Li, Hui-Sheng Chen","doi":"10.1136/svn-2023-002377","DOIUrl":"10.1136/svn-2023-002377","url":null,"abstract":"<p><strong>Background: </strong>Our recent pilot study suggests intra-arterial tenecteplase (TNK) during the first pass of endovascular treatment (EVT) seems safe, may increase first-pass reperfusion and good outcome in acute ischaemic stroke (AIS) patients with large-vessel occlusion (LVO).</p><p><strong>Aims: </strong>To determine the efficacy and safety of intra-arterial TNK administration during EVT in AIS-LVO patients presenting up to 24 hours from symptom onset.</p><p><strong>Sample size estimates: </strong>A maximum of 380 patients are required to test the superiority hypothesis with 80% power according to a two-side 0.05 level of significance, stratified by age, gender, baseline systolic blood pressure, prestroke modified Rankin Scale (mRS), baseline National Institute of Health stroke scale, baseline ASPECTS, time from onset to groin puncture, intravenous thrombolysis before EVT, stroke territory and stroke aetiology.</p><p><strong>Design: </strong>Intra-arterial TNK during thrombectomy for acute stroke (BRETIS-TNK II) study is a prospective, randomised, adaptive enrichment, open-label, blinded end point, multicentre study. Eligible AIS-LVO patients are randomly assigned into the experimental group and control group with a ratio of 1:1. The experimental group will be treated with intra-arterial infusion of TNK during EVT. The control group will be treated with standard EVT.</p><p><strong>Outcome: </strong>The primary end point is a favourable outcome, defined as an mRS score of 0-2 at 90 days. The primary safety end point is symptomatic intracranial haemorrhage within 48 hours, which is defined as an increase in the National Institutes of Health Stroke Scale score of ≥4 points as a result of the intracranial haemorrhage.</p><p><strong>Conclusions: </strong>The results of BRETIS-TNK II will provide evidence for the efficacy and safety of intra-arterial TNK administration during EVT in AIS patients with LVO.</p>","PeriodicalId":22021,"journal":{"name":"Stroke and Vascular Neurology","volume":" ","pages":"59-65"},"PeriodicalIF":5.9,"publicationDate":"2024-02-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10961245/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9448345","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Prehospital transdermal glyceryl trinitrate for ultra-acute ischaemic stroke: data from the RIGHT-2 randomised sham-controlled ambulance trial.","authors":"Jason Philip Appleton, Lisa J Woodhouse, Craig S Anderson, Sandeep Ankolekar, Lesley Cala, Mark Dixon, Timothy J England, Kailash Krishnan, Grant Mair, Keith W Muir, John Potter, Christopher I Price, Marc Randall, Thompson G Robinson, Christine Roffe, Else C Sandset, Jeffrey L Saver, Angela Shone, Aloysius Niroshan Siriwardena, Joanna M Wardlaw, Nikola Sprigg, Philip M Bath","doi":"10.1136/svn-2022-001634","DOIUrl":"10.1136/svn-2022-001634","url":null,"abstract":"<p><strong>Background: </strong>The effect of transdermal glyceryl trinitrate (GTN, a nitrovasodilator) on clinical outcome when administered before hospital admission in suspected stroke patients is unclear. Here, we assess the safety and efficacy of GTN in the prespecified subgroup of patients who had an ischaemic stroke within the Rapid Intervention with Glyceryl trinitrate in Hypertensive stroke Trial-2 (RIGHT-2).</p><p><strong>Methods: </strong>RIGHT-2 was an ambulance-based multicentre sham-controlled blinded-endpoint study with patients randomised within 4 hours of onset. The primary outcome was a shift in scores on the modified Rankin scale (mRS) at day 90. Secondary outcomes included death; a global analysis (Wei-Lachin test) containing Barthel Index, EuroQol-5D, mRS, telephone interview for cognitive status-modified and Zung depression scale; and neuroimaging-determined 'brain frailty' markers. Data were reported as n (%), mean (SD), median [IQR], adjusted common OR (acOR), mean difference or Mann-Whitney difference (MWD) with 95% CI.</p><p><strong>Results: </strong>597 of 1149 (52%) patients had a final diagnosis of ischaemic stroke; age 75 (12) years, premorbid mRS>2 107 (18%), Glasgow Coma Scale 14 (2) and time from onset to randomisation 67 [45, 108] min. Neuroimaging 'brain frailty' was common: median score 2 [2, 3] (range 0-3). At day 90, GTN did not influence the primary outcome (acOR for increased disability 1.15, 95% CI 0.85 to 1.54), death or global analysis (MWD 0.00, 95% CI -0.10 to 0.09). In subgroup analyses, there were non-significant interactions suggesting GTN may be associated with more death and dependency in participants randomised within 1 hour of symptom onset and in those with more severe stroke.</p><p><strong>Conclusions: </strong>In patients who had an ischaemic stroke, ultra-acute administration of transdermal GTN in the ambulance did not improve clinical outcomes in a population with more clinical and radiological frailty than seen in previous in-hospital trials.</p>","PeriodicalId":22021,"journal":{"name":"Stroke and Vascular Neurology","volume":" ","pages":"38-49"},"PeriodicalIF":5.9,"publicationDate":"2024-02-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10956104/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9963998","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Clinical features, treatment strategies and outcomes of craniocervical junction arteriovenous fistulas: a cohort study of 193 patients.","authors":"Yongjie Ma, Zihao Song, Yinqing Wang, Jiachen Wang, Chuan He, Guilin Li, Peng Zhang, Tao Hong, Liyong Sun, Peng Hu, Ming Ye, Hongqi Zhang","doi":"10.1136/svn-2023-002436","DOIUrl":"10.1136/svn-2023-002436","url":null,"abstract":"<p><strong>Background: </strong>Craniocervical junction (CCJ) arteriovenous fistulas (AVFs) are rare. The current treatment strategies for AVFs with different angioarchitecture need to be clarified. The present study aimed to analyse the correlation between angioarchitecture and clinical characteristics, share our experience in treating this disease and identify risk factors associated with subarachnoid haemorrhage (SAH) and poor outcomes.</p><p><strong>Methods: </strong>A total of 198 consecutive patients with CCJ AVFs from our neurosurgical centre were retrospectively reviewed. The patients were grouped according to their clinical manifestations, and their baseline clinical characteristics, angioarchitecture, treatment strategies and outcomes were summarised.</p><p><strong>Results: </strong>The patients' median age was 56 years (IQR 47-62 years). The majority of patients were men with 166 (83.8%) patients. The most common clinical manifestation was SAH (52.0%), followed by venous hypertensive myelopathy (VHM) (45.5%). The most common CCJ AVFs type was dural AVF, with 132 (63.5%) fistulas. The most frequent fistula location was C-1 (68.7%) and dural branch of vertebral artery (70.2%) was the most involved arterial feeders for fistulas. The most common direction of venous drainage was descending intradural drainage (40.9%), followed by ascending intradural drainage (36.5%). Microsurgery was the most common treatment strategy applied for 151 (76.3%) patients, 15 (7.6%) patients were treated with interventional embolisation only, and 27 (13.6%) received both interventional embolisation and microsurgical treatment. The learning curve for microsurgery only was analysed by cumulative summation method, and the turning point was the 70th case, and blood loss in post-group was lower than that in pre-group (p=0.034). At the last follow-up, there were 155 (78.3%) patients with favourable outcomes (modified Rankin Scale(mRS)<3). Age≥56 (OR 2.038, 95% CI 1.039 to 3.998, p=0.038), VHM as the clinical manifestation (OR 4.102, 95% CI 2.108 to 7.982, p<0.001) and pretreatment mRS≥3 (OR 3.127, 95% CI 1.617 to 6.047, p<0.001) were significantly associated with poor outcomes.</p><p><strong>Conclusion: </strong>The arterial feeders and direction of the venous drainage were important factors in the clinical presentations. The location of fistula and drainage vein was essential for choosing different treatment strategies. Older age, VHM onset and poor pretreatment functional status predicted poor outcomes.</p>","PeriodicalId":22021,"journal":{"name":"Stroke and Vascular Neurology","volume":" ","pages":"18-29"},"PeriodicalIF":5.9,"publicationDate":"2024-02-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10956106/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9525437","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Efficacy and safety of Y-2 sublingual tablet for patients with acute ischaemic stroke: protocol of a phase III randomised double-blind placebo-controlled multicentre trial.","authors":"Yu Fu, Renhong Tang, Rong Chen, Anxin Wang, Jinsheng Ren, Shunwei Zhu, Xiaofei Feng, Dongsheng Fan","doi":"10.1136/svn-2022-002014","DOIUrl":"10.1136/svn-2022-002014","url":null,"abstract":"<p><strong>Background and purpose: </strong>Clinical studies have demonstrated that edaravone dexborneol can improve the functional outcomes in patients with acute ischaemic stroke (AIS). The present clinical trial aimed at testing the efficacy and safety of Y-2 sublingual tablet on 90-day functional outcome in patients with AIS.</p><p><strong>Methods and design: </strong>This is a randomised, double-blind, placebo-controlled, multicentre, parallel-group trial of Y-2 sublingual tablet on patients with AIS.An estimated 914 patients at age of 18-80 years with AIS within 48 hours after symptom onset from 40 hospitals will be randomly assigned to receive Y-2 sublingual tablet or placebo for 14 days. Patients are at score 6-20 points on National Institutes of Health Stroke Scale (NIHSS) and had a modified Rankin Scale (mRS) ≤1 before this stroke, except mechanical thrombectomy and neuroprotective agents treatment.</p><p><strong>Study outcomes: </strong>The primary outcome is the proportion of patients with mRS ≤1 on day 90 after randomisation. Secondary efficacy outcomes include mRS score on day 90, the proportion of patients with mRS ≤2 on day 90; the change of NIHSS score from baseline to day 14 and the proportion of patients with NIHSS score ≤1 at the days 14, 30 and 90.</p><p><strong>Discussion: </strong>This trial will provide valuable evidence for the efficacy and safety of Y-2 sublingual table for improving 90 days the functional outcomes in patients with AIS.</p><p><strong>Trial registration number: </strong>NCT04950920.</p>","PeriodicalId":22021,"journal":{"name":"Stroke and Vascular Neurology","volume":" ","pages":"90-95"},"PeriodicalIF":5.9,"publicationDate":"2024-02-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10956111/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9675287","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Tirofiban combined with Aspirin in the Treatment of Acute Penetrating Artery Territory Infarction (STRATEGY): protocol for a multicentre, randomised controlled trial.","authors":"Xiaoling Liao, Shuo Feng, Yicong Wang, Yuesong Pan, Weiqi Chen, Hui Qu, Xingquan Zhao, Liping Liu, Yongjun Wang, Yilong Wang","doi":"10.1136/svn-2022-002284","DOIUrl":"10.1136/svn-2022-002284","url":null,"abstract":"<p><strong>Background: </strong>Perforating artery territorial infarction (PAI) caused by branch atheromatous disease (BAD) is prone to recurrence and early progression without an effective and well-documented antiplatelet treatment regimen. Tirofiban, an adjunctive antiplatelet agent, has shown great potential to treat acute ischaemic stroke. However, whether the combination of tirofiban and aspirin can improve the prognosis of PAI remains unclear.</p><p><strong>Aim: </strong>To explore an effective and safe antiplatelet regimen for reducing the risk of recurrence and early neurological deterioration (END) in PAI caused by BAD by comparing the tirofiban and aspirin combination with placebo and aspirin combination.</p><p><strong>Methods: </strong>Tirofiban combined with Aspirin in the Treatment of Acute Penetrating Artery Territory Infarction (STRATEGY) trial is an ongoing multicentre, randomised, placebo-controlled trial in China. Eligible patients shall be randomly assigned to receive standard aspirin with tirofiban or placebo on the first day and standard aspirin from days 2 to 90. The primary endpoint is a new stroke or END within 90 days. The primary safety endpoint is severe or moderate bleeding within 90 days.</p><p><strong>Discussion: </strong>The STRATEGY trial will assess whether tirofiban combined with aspirin is effective and safe in preventing recurrence and END in patients with PAI.</p><p><strong>Trial registration number: </strong>NCT05310968.</p>","PeriodicalId":22021,"journal":{"name":"Stroke and Vascular Neurology","volume":" ","pages":"75-81"},"PeriodicalIF":5.9,"publicationDate":"2024-02-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10956107/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9563510","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}