Cilostazol Dexborneol Versus Placebo for Microcirculation Dysfunction After Reperfusion Therapy in Patients With Acute Ischemic Stroke With Large Vessel Occlusion
NCT ID: NCT05836766
Last Updated: 2023-09-28
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
Recruitment Status
UNKNOWN
Clinical Phase
PHASE2
Total Enrollment
120 participants
Study Classification
INTERVENTIONAL
Study Start Date
2023-06-05
Study Completion Date
2024-08-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
This study aims to evaluate the efficacy of Y-6 sublingual tablets in improving microcirculation dysfunction and reducing thrombo-inflammation in patients who had AIS caused by LVO and received reperfusion therapy. Moreover, we expect to evaluate the safety of using Y-6 sublingual tablet in such study population.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
EFfects of Y-6 SUblingual Tablets foR PaTients With AcUte Ischemic StRokE (FUTURE)
NCT06138834
Acute Ischemic Stroke
Large Vessel Occlusion
Reperfusion
NOT_YET_RECRUITING
PHASE2
Y-6 Sublingual Tablets for Patients With Acute Ischemic Stroke
NCT07040085
Stroke
NOT_YET_RECRUITING
PHASE3
Treatment of Acute Ischemic Stroke With Edaravone Dexborneol Sublingual Tablets in Small Vessel Disease
NCT06674460
Cerebral Small Vessel Disease
Ischemic Stroke
RECRUITING
PHASE3
Clinical Trial of Umbilical Cord Mesenchymal Stem Cells in Subacute Ischemic Stroke
NCT07197606
Ischemic Stroke
NOT_YET_RECRUITING
PHASE2
MLC1501 Study Assessing Efficacy in STROke Recovery
NCT05046106
Stroke
Stroke, Ischemic
Strokes Thrombotic
+4 more
NOT_YET_RECRUITING
PHASE2/PHASE3
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
This study rationale is based on the following scheme: in patients with acute ischemic stroke caused by LVO, receiving reperfusion therapy may cause futile recanalization and thus lead to microcirculation dysfunction and thrombo-inflammation as consequences. Cilostazol has antiplatelet effects and BBB protection and Dexborneol has anti-inflammatory effects; therefore, the multi-component tablet may exert neuroprotective effects in terms of improving microcirculation dysfunction and reducing thrombo-inflammation in patients with AIS after reperfusion therapy.
The primary purpose of this study is to investigate the proportion of modified-Rankin scale (mRS) score recovered to 0\~1 score at 90±7 days after randomization.
The follow-up duration is 3 months, and the visit schedule is as follows: Subjects enrolled based on randomization procedures will receive visits at screening/baseline period, first drug administration, immediately after reperfusion therapy(within 2 hours), 24 ± 2 hours, 96 ± 7 hours, 14 ± 2 days, 28 ± 2 days and 90 ± 7 days after randomization, and in case of any events.
The primary purpose of this study is to investigate the proportion of modified-Rankin scale (mRS) score recovered to 0\~1 score at 90±7 days after randomization.
The follow-up duration is 3 months, and the visit schedule is as follows: Subjects enrolled based on randomization procedures will receive visits at screening/baseline period, first drug administration, immediately after reperfusion therapy(within 2 hours), 24 ± 2 hours, 96 ± 7 hours, 14 ± 2 days, 28 ± 2 days and 90 ± 7 days after randomization, and in case of any events.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Acute Ischemic Stroke
Reperfusion
Large Vessel Occlusion
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
QUADRUPLE
Participants
Caregivers
Investigators
Outcome Assessors
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Y-6 sublingual tablets
Y-6 sublingual tablets (each tablet contains 25 mg cilostazol and 6 mg dexborneol) Manufacturer: Nanjing Neurodawn Pharmaceutical Co., Ltd.
Group Type
ACTIVE_COMPARATOR
Y-6 sublingual tablets
Intervention Type
DRUG
Take Y-6 sublingual tablets for 28 days continuously.
Placebo tablets of Y-6 sublingual tablet
Y-6 strength: Placebo tablets of Y-6 sublingual tablet (each tablet contains 0 mg cilostazol and 0.06 mg dexborneol) Manufacturer: Nanjing Neurodawn Pharmaceutical Co., Ltd.
Group Type
PLACEBO_COMPARATOR
Placebo tablets of Y-6 sublingual tablet
Intervention Type
DRUG
Take Placebo tablets of Y-6 sublingual tablet for 28 days continuously.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Y-6 sublingual tablets
Take Y-6 sublingual tablets for 28 days continuously.
Intervention Type
DRUG
Placebo tablets of Y-6 sublingual tablet
Take Placebo tablets of Y-6 sublingual tablet for 28 days continuously.
Intervention Type
DRUG
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 35 years old ≤ Age ≤ 80 years old
* Patients with acute ischemic stroke was diagnosed within 24 hours of onset (time from onset to completion of reperfusion therapy)
* Patients with first stroke or prior to stroke onset (mRS score 0-1)
* Patients with acute large vessel occlusion (LVO) confirmed by imaging, including the responsible vessel was located in the intracranial internal carotid artery, the T-shaped branch, the M1/M2 segment of the middle cerebral artery, or the A1/A2 segment of the anterior cerebral artery
* ASPECTS score ≥ 6
* 6\<NIHSS score ≤ 25 after the onset of this disease
* Patients who meet the indications for reperfusion therapy, including mechanical thrombectomy, bridging therapy (intravenous r-tPA thrombolytic therapy), and plan to undergo mechanical thrombectomy
* Patients or his/her legal representatives are able to understand and sign the informed consent
* Patients with acute ischemic stroke was diagnosed within 24 hours of onset (time from onset to completion of reperfusion therapy)
* Patients with first stroke or prior to stroke onset (mRS score 0-1)
* Patients with acute large vessel occlusion (LVO) confirmed by imaging, including the responsible vessel was located in the intracranial internal carotid artery, the T-shaped branch, the M1/M2 segment of the middle cerebral artery, or the A1/A2 segment of the anterior cerebral artery
* ASPECTS score ≥ 6
* 6\<NIHSS score ≤ 25 after the onset of this disease
* Patients who meet the indications for reperfusion therapy, including mechanical thrombectomy, bridging therapy (intravenous r-tPA thrombolytic therapy), and plan to undergo mechanical thrombectomy
* Patients or his/her legal representatives are able to understand and sign the informed consent
Exclusion Criteria
* Severe consciousness disturbance: NIHSS 1a consciousness level ≥2 points
* Patients with definite history of intracranial hemorrhage (such as subarachnoid hemorrhage, cerebral hemorrhage, etc.)
* Patients with intracranial tumor, arteriovenous malformation, or aneurysm
* Patients with bilateral anterior or posterior circulation ischemic stroke
* Patients with large vascular occlusion of rare or unknown etiology, such as dissection, vasculitis, etc.
* Patients who have received treatment with dual antiplatelet drugs, tirofiban, warfarin, novel oral anticoagulant, argatroban, snake venom, defibrase, lumbrokinase and other defibrase therapy after the onset of disease
* Patients with severe hepatic insufficiency or renal insufficiency and received dialysis for various reasons before randomization (severe hepatic insufficiency is defined as ALT \> 3 × ULN or AST \>3 × ULN; severe renal insufficiency is defined as serum creatinine \>3.0 mg/dL (265.2 μmol/L) or creatinine clearance \< 30 mL/min)
* Patients with haemorrhagic diathesis (including but not limited to): platelet count \< 100 × 109/L; heparin treatment within the last 48 hours; taking oral warfarin; taking novel oral anticoagulant; administration with direct thrombin or Xa factor inhibitors; with hereditary hemorrhagic disorders, such as hemophilia
* Patients with refractory hypertension that is difficult to be controlled by medication (systolic blood pressure \> 180 mmHg or diastolic blood pressure \> 110 mmHg)
* Patients with significant head trauma or stroke within 3 months prior to randomization
* Patients who have received intracranial or spinal surgery within 3 months prior to randomization
* Patients with history of major surgery or serious physical trauma within 1 month prior to randomization
* Patients with hemorrhagic retinopathy
* Male subjects (or their partners) or female subjects who had planned to have a child during the whole study period and within 3 months after the end of the study period or were unwilling to use one or more non-drug contraceptive methods (e.g., complete abstinence, condoms, ligation, etc.) during the study period
* Patients with contraindications to known contrast agent or other contrast agents; subjects who are allergic to cilostazol or dexborneol
* Patients who plan to receive other surgical or intervention therapy within 3 months, which might require discontinuation of the study drugs
* Patients with advanced disease, leading to life expectancy of \< 6 months
* Patients who have received treatment of investigational drug or device within 3 months
* Other conditions where it is not suitable for patients to participate in the clinical trial, such as inability to understand and/or follow the study procedures and/or follow-up schedule due to psychiatric disorders or cognitive/emotional disorders, or contraindications to thrombectomy or MRI, etc.
* Patients with definite history of intracranial hemorrhage (such as subarachnoid hemorrhage, cerebral hemorrhage, etc.)
* Patients with intracranial tumor, arteriovenous malformation, or aneurysm
* Patients with bilateral anterior or posterior circulation ischemic stroke
* Patients with large vascular occlusion of rare or unknown etiology, such as dissection, vasculitis, etc.
* Patients who have received treatment with dual antiplatelet drugs, tirofiban, warfarin, novel oral anticoagulant, argatroban, snake venom, defibrase, lumbrokinase and other defibrase therapy after the onset of disease
* Patients with severe hepatic insufficiency or renal insufficiency and received dialysis for various reasons before randomization (severe hepatic insufficiency is defined as ALT \> 3 × ULN or AST \>3 × ULN; severe renal insufficiency is defined as serum creatinine \>3.0 mg/dL (265.2 μmol/L) or creatinine clearance \< 30 mL/min)
* Patients with haemorrhagic diathesis (including but not limited to): platelet count \< 100 × 109/L; heparin treatment within the last 48 hours; taking oral warfarin; taking novel oral anticoagulant; administration with direct thrombin or Xa factor inhibitors; with hereditary hemorrhagic disorders, such as hemophilia
* Patients with refractory hypertension that is difficult to be controlled by medication (systolic blood pressure \> 180 mmHg or diastolic blood pressure \> 110 mmHg)
* Patients with significant head trauma or stroke within 3 months prior to randomization
* Patients who have received intracranial or spinal surgery within 3 months prior to randomization
* Patients with history of major surgery or serious physical trauma within 1 month prior to randomization
* Patients with hemorrhagic retinopathy
* Male subjects (or their partners) or female subjects who had planned to have a child during the whole study period and within 3 months after the end of the study period or were unwilling to use one or more non-drug contraceptive methods (e.g., complete abstinence, condoms, ligation, etc.) during the study period
* Patients with contraindications to known contrast agent or other contrast agents; subjects who are allergic to cilostazol or dexborneol
* Patients who plan to receive other surgical or intervention therapy within 3 months, which might require discontinuation of the study drugs
* Patients with advanced disease, leading to life expectancy of \< 6 months
* Patients who have received treatment of investigational drug or device within 3 months
* Other conditions where it is not suitable for patients to participate in the clinical trial, such as inability to understand and/or follow the study procedures and/or follow-up schedule due to psychiatric disorders or cognitive/emotional disorders, or contraindications to thrombectomy or MRI, etc.
Minimum Eligible Age
35 Years
Maximum Eligible Age
80 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Neurodawn Pharmaceutical Co., Ltd.
INDUSTRY
Sponsor Role
collaborator
Beijing Tiantan Hospital
OTHER
Sponsor Role
lead
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
yilong Wang
Professor
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Yilong Wang, PhD，MD
Role: PRINCIPAL_INVESTIGATOR
Beijing Tiantan Hospital, Capital Medical University, Beijing, China
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Liuzhou Workers' Hospital
Liuzhou, Guangxi, China
Site Status
RECRUITING
Hunan Provincial People's Hospital
Changsha, Hunan, China
Site Status
RECRUITING
Pingxiang people's hospital
Pingxiang, Jiangxi, China
Site Status
RECRUITING
Countries
Review the countries where the study has at least one active or historical site.
China
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Yang Hong
Role: primary
Role: backup
Zhao Zhihong
Role: primary
Role: backup
Yi Fei
Role: primary
Role: backup
References
Explore related publications, articles, or registry entries linked to this study.
Smith WS, Lev MH, English JD, Camargo EC, Chou M, Johnston SC, Gonzalez G, Schaefer PW, Dillon WP, Koroshetz WJ, Furie KL. Significance of large vessel intracranial occlusion causing acute ischemic stroke and TIA. Stroke. 2009 Dec;40(12):3834-40. doi: 10.1161/STROKEAHA.109.561787. Epub 2009 Oct 15.
Reference Type
BACKGROUND
Goyal M, Menon BK, van Zwam WH, Dippel DW, Mitchell PJ, Demchuk AM, Davalos A, Majoie CB, van der Lugt A, de Miquel MA, Donnan GA, Roos YB, Bonafe A, Jahan R, Diener HC, van den Berg LA, Levy EI, Berkhemer OA, Pereira VM, Rempel J, Millan M, Davis SM, Roy D, Thornton J, Roman LS, Ribo M, Beumer D, Stouch B, Brown S, Campbell BC, van Oostenbrugge RJ, Saver JL, Hill MD, Jovin TG; HERMES collaborators. Endovascular thrombectomy after large-vessel ischaemic stroke: a meta-analysis of individual patient data from five randomised trials. Lancet. 2016 Apr 23;387(10029):1723-31. doi: 10.1016/S0140-6736(16)00163-X. Epub 2016 Feb 18.
Reference Type
BACKGROUND
van Horn N, Kniep H, Leischner H, McDonough R, Deb-Chatterji M, Broocks G, Thomalla G, Brekenfeld C, Fiehler J, Hanning U, Flottmann F. Predictors of poor clinical outcome despite complete reperfusion in acute ischemic stroke patients. J Neurointerv Surg. 2021 Jan;13(1):14-18. doi: 10.1136/neurintsurg-2020-015889. Epub 2020 May 15.
Reference Type
BACKGROUND
Ng FC, Coulton B, Chambers B, Thijs V. Persistently Elevated Microvascular Resistance Postrecanalization. Stroke. 2018 Oct;49(10):2512-2515. doi: 10.1161/STROKEAHA.118.021631.
Reference Type
BACKGROUND
Emberson J, Lees KR, Lyden P, Blackwell L, Albers G, Bluhmki E, Brott T, Cohen G, Davis S, Donnan G, Grotta J, Howard G, Kaste M, Koga M, von Kummer R, Lansberg M, Lindley RI, Murray G, Olivot JM, Parsons M, Tilley B, Toni D, Toyoda K, Wahlgren N, Wardlaw J, Whiteley W, del Zoppo GJ, Baigent C, Sandercock P, Hacke W; Stroke Thrombolysis Trialists' Collaborative Group. Effect of treatment delay, age, and stroke severity on the effects of intravenous thrombolysis with alteplase for acute ischaemic stroke: a meta-analysis of individual patient data from randomised trials. Lancet. 2014 Nov 29;384(9958):1929-35. doi: 10.1016/S0140-6736(14)60584-5. Epub 2014 Aug 5.
Reference Type
BACKGROUND
Powers WJ, Rabinstein AA, Ackerson T, Adeoye OM, Bambakidis NC, Becker K, Biller J, Brown M, Demaerschalk BM, Hoh B, Jauch EC, Kidwell CS, Leslie-Mazwi TM, Ovbiagele B, Scott PA, Sheth KN, Southerland AM, Summers DV, Tirschwell DL. Guidelines for the Early Management of Patients With Acute Ischemic Stroke: 2019 Update to the 2018 Guidelines for the Early Management of Acute Ischemic Stroke: A Guideline for Healthcare Professionals From the American Heart Association/American Stroke Association. Stroke. 2019 Dec;50(12):e344-e418. doi: 10.1161/STR.0000000000000211. Epub 2019 Oct 30.
Reference Type
BACKGROUND
Hussein HM, Georgiadis AL, Vazquez G, Miley JT, Memon MZ, Mohammad YM, Christoforidis GA, Tariq N, Qureshi AI. Occurrence and predictors of futile recanalization following endovascular treatment among patients with acute ischemic stroke: a multicenter study. AJNR Am J Neuroradiol. 2010 Mar;31(3):454-8. doi: 10.3174/ajnr.A2006. Epub 2010 Jan 14.
Reference Type
BACKGROUND
Casetta I, Fainardi E, Saia V, Pracucci G, Padroni M, Renieri L, Nencini P, Inzitari D, Morosetti D, Sallustio F, Vallone S, Bigliardi G, Zini A, Longo M, Francalanza I, Bracco S, Vallone IM, Tassi R, Bergui M, Naldi A, Saletti A, De Vito A, Gasparotti R, Magoni M, Castellan L, Serrati C, Menozzi R, Scoditti U, Causin F, Pieroni A, Puglielli E, Casalena A, Sanna A, Ruggiero M, Cordici F, Di Maggio L, Duc E, Cosottini M, Giannini N, Sanfilippo G, Zappoli F, Cavallini A, Cavasin N, Critelli A, Ciceri E, Plebani M, Cappellari M, Chiumarulo L, Petruzzellis M, Terrana A, Cariddi LP, Burdi N, Tinelli A, Auteri W, Silvagni U, Biraschi F, Nicolini E, Padolecchia R, Tassinari T, Filauri P, Sacco S, Pavia M, Invernizzi P, Nuzzi NP, Marcheselli S, Amista P, Russo M, Gallesio I, Craparo G, Mannino M, Mangiafico S, Toni D; Italian Registry of Endovascular Treatment in Acute Stroke. Endovascular Thrombectomy for Acute Ischemic Stroke Beyond 6 Hours From Onset: A Real-World Experience. Stroke. 2020 Jul;51(7):2051-2057. doi: 10.1161/STROKEAHA.119.027974. Epub 2020 Jun 17.
Reference Type
BACKGROUND
Berkhemer OA, Jansen IG, Beumer D, Fransen PS, van den Berg LA, Yoo AJ, Lingsma HF, Sprengers ME, Jenniskens SF, Lycklama A Nijeholt GJ, van Walderveen MA, van den Berg R, Bot JC, Beenen LF, Boers AM, Slump CH, Roos YB, van Oostenbrugge RJ, Dippel DW, van der Lugt A, van Zwam WH, Marquering HA, Majoie CB; MR CLEAN Investigators. Collateral Status on Baseline Computed Tomographic Angiography and Intra-Arterial Treatment Effect in Patients With Proximal Anterior Circulation Stroke. Stroke. 2016 Mar;47(3):768-76. doi: 10.1161/STROKEAHA.115.011788. Epub 2016 Jan 28.
Reference Type
BACKGROUND
Groot AE, Treurniet KM, Jansen IGH, Lingsma HF, Hinsenveld W, van de Graaf RA, Roozenbeek B, Willems HC, Schonewille WJ, Marquering HA, van den Berg R, Dippel DWJ, Majoie CBLM, Roos YBWEM, Coutinho JM; MR CLEAN Registry Investigators. Endovascular treatment in older adults with acute ischemic stroke in the MR CLEAN Registry. Neurology. 2020 Jul 14;95(2):e131-e139. doi: 10.1212/WNL.0000000000009764. Epub 2020 Jun 11.
Reference Type
BACKGROUND
Hussein HM, Saleem MA, Qureshi AI. Rates and predictors of futile recanalization in patients undergoing endovascular treatment in a multicenter clinical trial. Neuroradiology. 2018 May;60(5):557-563. doi: 10.1007/s00234-018-2016-2. Epub 2018 Mar 25.
Reference Type
BACKGROUND
Rubiera M, Garcia-Tornel A, Olive-Gadea M, Campos D, Requena M, Vert C, Pagola J, Rodriguez-Luna D, Muchada M, Boned S, Rodriguez-Villatoro N, Juega J, Deck M, Sanjuan E, Hernandez D, Pinana C, Tomasello A, Molina CA, Ribo M. Computed Tomography Perfusion After Thrombectomy: An Immediate Surrogate Marker of Outcome After Recanalization in Acute Stroke. Stroke. 2020 Jun;51(6):1736-1742. doi: 10.1161/STROKEAHA.120.029212. Epub 2020 May 14.
Reference Type
BACKGROUND
Raja R, Rosenberg GA, Caprihan A. MRI measurements of Blood-Brain Barrier function in dementia: A review of recent studies. Neuropharmacology. 2018 May 15;134(Pt B):259-271. doi: 10.1016/j.neuropharm.2017.10.034. Epub 2017 Oct 28.
Reference Type
BACKGROUND
Bai R, Li Z, Sun C, Hsu YC, Liang H, Basser P. Feasibility of filter-exchange imaging (FEXI) in measuring different exchange processes in human brain. Neuroimage. 2020 Oct 1;219:117039. doi: 10.1016/j.neuroimage.2020.117039. Epub 2020 Jun 10.
Reference Type
BACKGROUND
Batra A, Latour LL, Ruetzler CA, Hallenbeck JM, Spatz M, Warach S, Henning EC. Increased plasma and tissue MMP levels are associated with BCSFB and BBB disruption evident on post-contrast FLAIR after experimental stroke. J Cereb Blood Flow Metab. 2010 Jun;30(6):1188-99. doi: 10.1038/jcbfm.2010.1. Epub 2010 Mar 3.
Reference Type
BACKGROUND
Koh SX, Lee JK. S100B as a marker for brain damage and blood-brain barrier disruption following exercise. Sports Med. 2014 Mar;44(3):369-85. doi: 10.1007/s40279-013-0119-9.
Reference Type
BACKGROUND
El Amki M, Gluck C, Binder N, Middleham W, Wyss MT, Weiss T, Meister H, Luft A, Weller M, Weber B, Wegener S. Neutrophils Obstructing Brain Capillaries Are a Major Cause of No-Reflow in Ischemic Stroke. Cell Rep. 2020 Oct 13;33(2):108260. doi: 10.1016/j.celrep.2020.108260.
Reference Type
BACKGROUND
Stoll G, Nieswandt B. Thrombo-inflammation in acute ischaemic stroke - implications for treatment. Nat Rev Neurol. 2019 Aug;15(8):473-481. doi: 10.1038/s41582-019-0221-1. Epub 2019 Jul 1.
Reference Type
BACKGROUND
Kollikowski AM, Schuhmann MK, Nieswandt B, Mullges W, Stoll G, Pham M. Local Leukocyte Invasion during Hyperacute Human Ischemic Stroke. Ann Neurol. 2020 Mar;87(3):466-479. doi: 10.1002/ana.25665. Epub 2020 Jan 16.
Reference Type
BACKGROUND
El Amki M, Wegener S. Improving Cerebral Blood Flow after Arterial Recanalization: A Novel Therapeutic Strategy in Stroke. Int J Mol Sci. 2017 Dec 9;18(12):2669. doi: 10.3390/ijms18122669.
Reference Type
BACKGROUND
Bustamante A, Ning M, Garcia-Berrocoso T, Penalba A, Boada C, Simats A, Pagola J, Ribo M, Molina C, Lo E, Montaner J. Usefulness of ADAMTS13 to predict response to recanalization therapies in acute ischemic stroke. Neurology. 2018 Mar 20;90(12):e995-e1004. doi: 10.1212/WNL.0000000000005162. Epub 2018 Feb 14.
Reference Type
BACKGROUND
Gragnano F, Sperlongano S, Golia E, Natale F, Bianchi R, Crisci M, Fimiani F, Pariggiano I, Diana V, Carbone A, Cesaro A, Concilio C, Limongelli G, Russo M, Calabro P. The Role of von Willebrand Factor in Vascular Inflammation: From Pathogenesis to Targeted Therapy. Mediators Inflamm. 2017;2017:5620314. doi: 10.1155/2017/5620314. Epub 2017 May 28.
Reference Type
BACKGROUND
Nieswandt B, Kleinschnitz C, Stoll G. Ischaemic stroke: a thrombo-inflammatory disease? J Physiol. 2011 Sep 1;589(17):4115-23. doi: 10.1113/jphysiol.2011.212886. Epub 2011 Jul 18.
Reference Type
BACKGROUND
Kraft P, Gob E, Schuhmann MK, Gobel K, Deppermann C, Thielmann I, Herrmann AM, Lorenz K, Brede M, Stoll G, Meuth SG, Nieswandt B, Pfeilschifter W, Kleinschnitz C. FTY720 ameliorates acute ischemic stroke in mice by reducing thrombo-inflammation but not by direct neuroprotection. Stroke. 2013 Nov;44(11):3202-10. doi: 10.1161/STROKEAHA.113.002880. Epub 2013 Sep 12.
Reference Type
BACKGROUND
Schuhmann MK, Guthmann J, Stoll G, Nieswandt B, Kraft P, Kleinschnitz C. Blocking of platelet glycoprotein receptor Ib reduces "thrombo-inflammation" in mice with acute ischemic stroke. J Neuroinflammation. 2017 Jan 21;14(1):18. doi: 10.1186/s12974-017-0792-y.
Reference Type
BACKGROUND
Takagi T, Hara H. Protective effects of cilostazol against hemorrhagic stroke: Current and future perspectives. J Pharmacol Sci. 2016 Jul;131(3):155-61. doi: 10.1016/j.jphs.2016.04.023. Epub 2016 May 3.
Reference Type
BACKGROUND
Horai S, Nakagawa S, Tanaka K, Morofuji Y, Couraud PO, Deli MA, Ozawa M, Niwa M. Cilostazol strengthens barrier integrity in brain endothelial cells. Cell Mol Neurobiol. 2013 Mar;33(2):291-307. doi: 10.1007/s10571-012-9896-1. Epub 2012 Dec 7.
Reference Type
BACKGROUND
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
YW2022-046-03
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.
Study of Modified Stem Cells (SB623) in Patients With Chronic Motor Deficit From Ischemic Stroke
NCT02448641
COMPLETED
PHASE2
Safety and Efficacy of Edaravone Dexborneol for Acute Ischemic Stroke
NCT06645522
NOT_YET_RECRUITING
PHASE4
Effect of Interleukin-6 Receptor Inhibition in Patients With Ischemic Stroke Undergoing Endovascular Treatment
NCT06238024
COMPLETED
PHASE2/PHASE3
Extending the Time Window for Intravenous Tenecteplase in Patients With Distal Medium Vessel Occlusions Stroke
NCT06559436
RECRUITING
NA
Study of Human Placenta-derived Cells (PDA001) to Evaluate the Safety and Effectiveness for Patients With Ischemic Stroke
NCT01310114
TERMINATED
PHASE2
Efficacy and Safety of Sarecycline in Patients With Acute Ischemic Stroke After Reperfusion Therapy
NCT05836753
UNKNOWN
PHASE2
Efficacy and Safety Study of Ultra-early Mobile Stroke Unit Neuroprotection Combined With Revascularization for Acute Ischemic Stroke (EXCELLENT)
NCT07119021
RECRUITING
PHASE4
Effectiveness and Safety of Edaravone Dexborneol in Acute Ischemic Stroke
NCT05644223
UNKNOWN
Thrombolysis Combined With Edaravone Dexborneol on Hemorrhagic Transformation for Acute Ischemic Stroke
NCT05035953
UNKNOWN
PHASE2
Efficacy and Safety Study of Neu2000KWL for Acute Ischemic Stroke Patients Within 6 Hours of Onset
NCT04486430
COMPLETED
PHASE2
Effects of Cerebrolysin on Motor Recovery in Patients With Subacute Stroke
NCT01996761
COMPLETED
PHASE4
BXOS110 Injection in the Treatment of Acute Ischaemic Stroke
NCT06322394
RECRUITING
PHASE2
Edaravone Dexborneol Sublingual Tablet for the PSCI in Acute Ischemic Stroke Patients
NCT06315231
RECRUITING
PHASE2
The Efficacy and Safety of Edaravone Dexborneol Sequential Therapy in the Treatment of Patients With AIS
NCT06176781
NOT_YET_RECRUITING
PHASE3
Effect of Early Versus Late Initiation of Edaravone Dexborneol on Neural Function in Patients With Acute Ischemic Stroke
NCT05885919
UNKNOWN
PHASE3
Efficacy and Safety of Human Urinary Kallidinogenase Combined With Endovascular Therapy in Acute Ischemic Stroke With Large Vessel Occlusion
NCT06211712
RECRUITING
NA
The Effect of GD-iExo-003 in Acute Ischemic Stroke
NCT06138210
RECRUITING
PHASE1/PHASE2
Methylprednisolone With Endovascular Thrombectomy for Large Ischemic Stroke
NCT06870448
NOT_YET_RECRUITING
PHASE3
Efficacy of SUN N4057 in Subjects With Acute Ischemic Stroke and Measurable Penumbra on Magnetic Resonance Imaging (MRI)
NCT00272909
TERMINATED
PHASE2
Tenecteplase Reperfusion Therapy in Acute Ischaemic Cerebrovascular Events-5
NCT06196320
COMPLETED
PHASE3
A Prospective, Multicentre, Randomized Controlled Trial of Edaravone Dexborneol in Acute Ischemic Stroke With Active Malignancy
NCT07091994
NOT_YET_RECRUITING
PHASE4
Efficacy and Safety of Interleukin-6 Receptor Inhibitor Combined With Endovascular Treatment in Patients With Acute Anterior Circulation Large Vessel Occlusion Stroke -2
NCT07263776
RECRUITING
PHASE3
Methylprednisolone Sodium Succinate With Endovascular ThRombectomy for Large Ischemic STroke
NCT07175649
NOT_YET_RECRUITING
NA
Protective Effects of Edaravone Dexborneol
NCT05024526
UNKNOWN
NA
Intravenous Thrombolytic Therapy for Acute Ischemic Stroke Patients with Low NIHSS and Non-disabling Deficits
NCT06115070
NOT_YET_RECRUITING
PHASE4