Účinnost a bezpečnost lidské moči Kallidinogenáza pro pacienty s akutní ischemickou mrtvicí, kteří dostávají léčbu reperfuze (UNITE)
18. září 2026 aktualizováno: yilong Wang, Beijing Tiantan Hospital
This study aims to explore the efficacy and safety of Human Urinary Kallidinogenase for acute ischemic stroke patients receiving intravenous thrombolysis and/or endovascular treatment.
Přehled studie
Postavení
Postavení
Zápis na pozvánku
Podmínky
Podmínky
Intervence / Léčba
Intervence / Léčba
Detailní popis
Within 24 hours after symptom onset, eligible participants will be randomly assigned in a 1:1 ratio to the HUK or placebo group, receiving adjunctive HUK or placebo treatment alongside standard intravenous thrombolysis and/or endovascular treatment. All participants will be recommended to continuously inject drugs or placebo for 10 to 14 days according to length of hospitalization.
- Intervention group: HUK (0.15 PNA) and sodium chloride injection (100ml), once per day
- Control group: placebo (0 PNA) and sodium chloride injection (100ml), once per day The total follow-up duration is 90 days.
Typ studie
Typ studie
Intervenční
Zápis (Odhadovaný)
Zápis
1204
Fáze
Fáze
- Nelze použít
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
-
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Beijing Municipality
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Beijing, Beijing Municipality, Čína, 100070
- Beijing Tiantan Hospital, Capital Medical University
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Kritéria způsobilosti
Věk způsobilý ke studiu
18 let a starší (Dospělý, Starší dospělý)
Přijímá zdravé dobrovolníky
Ne
Pohlaví způsobilá ke studiu
Všechno
Popis
Inclusion Criteria:
- Age ≥18 years.
- Having anterior circulation AIS within 24 hours of onset.
- The NIHSS score at enrollment is 4 to 25.
- Receiving intravenous recombinant tissue plasminogen activator (rt-PA) or TNK-tPA, or endovascular treatment including intra-arterial thrombolysis, mechanical thrombectomy, or intravenous rt-PA /TNK-tPA bridging endovascular treatment.
- Being independent in daily activities (mRS ≤1) before onset.
- Patients or their legal representatives are able and willing to sign informed consent forms.
Exclusion Criteria:
- Having an Alberta Stroke Program Early Computed Tomography Score (ASPECT) score of 6 or less confirmed by preoperational computed tomography scan.
- Being already treated with HUK or any drugs containing HUK after onset.
- Having an allergy history of HUK or drugs containing HUK, or other drugs and food.
- Having a history of coagulation dysfunction, systemic bleeding, or thrombocytopenia; having hemorrhagic diseases at the time of enrollment, including cerebral hemorrhage, subarachnoid hemorrhage, epidural or subdural hematoma, gingival bleeding, gastrointestinal bleeding, dermal ecchymosis, etc; taking anticoagulants including warfarin, rivaroxaban, etc.; or taking heparin within 48 hours after stroke onset.
- Taking angiotensin-converting enzyme inhibitor (ACEI) antihypertensive drugs regularly within one week before enrollment, including captopril, enalapril, benazepril, etc.
- Having chronic liver disease or liver dysfunction, with elevated ALT/AST (>3.0×ULN ); or having kidney dysfunction or receiving dialysis, with elevated serum creatinine (>2.0×ULN).
- Having severe cardiopulmonary disease that are deemed unsuitable for the study by the investigators.
- Having contraindications for intravenous thrombolysis or endovascular treatment, including intra-arterial thrombolysis, mechanical thrombectomy, or intravenous rt-PA /TNK-tPA bridging endovascular treatment.
- Having lethal diseases with a life expectancy < 3 months.
- Being pregnant or lactating; or women of child-bearing age not taking effective contraception, or having no negative pregnancy test record.
- Being unable to complete the study due to mental illness, cognitive or emotional disorder, physical condition, geographical factors, etc.
- Participating in another clinical trial currently.
- Other conditions that investigators consider he/she is not appropriate to participate in this study.
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Čtyřnásobek
Počet zbraní
2
Zbraně a zásahy
Skupina účastníků / ArmSkupina účastníků / Arm |
Intervence / LéčbaIntervence / Léčba |
|---|---|
|
Experimentální: Intervention group
HUK (0.15 PNA) and sodium chloride injection (100ml), once per day |
HUK (0.15 PNA) and sodium chloride injection (100ml), once per day |
|
Komparátor placeba: Control group
placebo (0 PNA) and sodium chloride injection (100ml), once per day |
placebo (0 PNA) and sodium chloride injection (100ml), once per day |
Co je měření studie?
Primární výstupní opatření
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Proportion of a favorable outcome (mRS 0-2)
Časové okno: at 90 days
|
The proportion of a favorable outcome, defined by a modified Rankin Scale (mRS) score ranging from 0 to 2, reflects the percentage of patients who attained a functional status from no symptoms to mild disability, enabling them to perform all pre-stroke activities without assistance. |
at 90 days
|
Sekundární výstupní opatření
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Proportion of a favorable outcome (mRS 0-2)
Časové okno: at 14 days
|
The proportion of a favorable outcome, defined by a modified Rankin Scale (mRS) score ranging from 0 to 2, reflects the percentage of patients who attained a functional status from no symptoms to mild disability, enabling them to perform all pre-stroke activities without assistance. |
at 14 days
|
|
Proportion of an excellent outcome (mRS 0-1)
Časové okno: at 90 days
|
The proportion of an excellent outcome, characterized by a modified Rankin Scale (mRS) score of 0 to 1, represents the percentage of patients who achieved a functional status from no symptoms to no significant disability despite symptoms, allowing them to resume all pre-stroke activities without any aid. |
at 90 days
|
|
Distribution of mRS score
Časové okno: at 90 days
|
The distribution of modified Rankin Scale (mRS) scores provides a comprehensive overview of the functional outcomes across a patient population, categorizing the degree of disability from no symptoms (score 0) to severe disability or death (score 6). |
at 90 days
|
|
Improvement of NIHSS score
Časové okno: at 14 days
|
The improvement of the National Institutes of Health Stroke Scale (NIHSS) score serves as a quantifiable measure of neurological recovery, reflecting the reduction in stroke-related deficits and the enhancement of patient functional capabilities over time. Minimum Score: 0 (no stroke symptoms) Maximum Score: 42 (severe stroke) Higher NIHSS scores indicate more severe stroke symptoms and are associated with worse outcomes.Lower NIHSS scores indicate milder stroke symptoms and are associated with better outcomes. |
at 14 days
|
|
Risk of recurrent symptomatic stroke
Časové okno: within 90 days
|
The risk of recurrent symptomatic stroke quantifies the probability of a subsequent stroke event with clinical manifestations, providing a critical measure for assessing the long-term efficacy of stroke prevention strategies and the ongoing vulnerability of the patient population. |
within 90 days
|
|
Risk of recurrent symptomatic ischemic stroke
Časové okno: within 90 days
|
The risk of recurrent symptomatic ischemic stroke delineates the likelihood of a subsequent ischemic stroke event accompanied by clinical symptoms, serving as a pivotal indicator for evaluating the effectiveness of secondary prevention measures and the persistent threat of cerebral ischemia in affected individuals. |
within 90 days
|
|
Risk of combined vascular events
Časové okno: within 90 days
|
The risk of combined vascular events encompasses the probability of experiencing any major vascular incident, such as stroke, myocardial infarction, or vascular death, offering a comprehensive metric for assessing the overall burden of vascular disease and the aggregate impact of therapeutic interventions on cardiovascular health. |
within 90 days
|
|
Improvement of EQ-5D-5L
Časové okno: at 90 days
|
The improvement of EQ-5D-5L(EuroQol 5-Dimension 5-Level) reflects an enhancement in health-related quality of life, as measured by gains across five dimensions-mobility, self-care, usual activities, pain/discomfort, and anxiety/depression-on a five-level severity scale, indicating a positive shift in the patient's overall health state and well-being. Minimum Score: 0 (worst imaginable health state) Maximum Score: 100 (best imaginable health state) For the descriptive system, a lower score (closer to 11111) indicates better health-related quality of life, while a higher score (closer to 55555) indicates worse health-related quality of life. For the VAS, a higher score (closer to 100) indicates better self-rated health, while a lower score (closer to 0) indicates worse self-rated health. |
at 90 days
|
|
Improvement of MOCA
Časové okno: at 90 days
|
The improvement of the Montreal Cognitive Assessment (MoCA) score signifies an enhancement in cognitive function, encompassing domains such as attention, memory, language, and executive functions, thereby indicating a positive progression in the patient's cognitive status and potential recovery from cognitive impairment. Minimum Score: 0 (severe cognitive impairment) Maximum Score: 30 (no cognitive impairment) Higher MoCA scores indicate better cognitive function. Lower MoCA scores indicate worse cognitive function. |
at 90 days
|
Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Sponzor
Vyšetřovatelé
Vyšetřovatelé
- Studijní židle: Wang Yilong, MD, PhD, Beijing Tiantan Hospital
- Ředitel studie: Wang Tingting, MD, Beijing Tiantan Hospital
Publikace a užitečné odkazy
Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.
Obecné publikace
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- Campbell BC, Mitchell PJ, Kleinig TJ, Dewey HM, Churilov L, Yassi N, Yan B, Dowling RJ, Parsons MW, Oxley TJ, Wu TY, Brooks M, Simpson MA, Miteff F, Levi CR, Krause M, Harrington TJ, Faulder KC, Steinfort BS, Priglinger M, Ang T, Scroop R, Barber PA, McGuinness B, Wijeratne T, Phan TG, Chong W, Chandra RV, Bladin CF, Badve M, Rice H, de Villiers L, Ma H, Desmond PM, Donnan GA, Davis SM; EXTEND-IA Investigators. Endovascular therapy for ischemic stroke with perfusion-imaging selection. N Engl J Med. 2015 Mar 12;372(11):1009-18. doi: 10.1056/NEJMoa1414792. Epub 2015 Feb 11.
- Saver JL, Goyal M, Bonafe A, Diener HC, Levy EI, Pereira VM, Albers GW, Cognard C, Cohen DJ, Hacke W, Jansen O, Jovin TG, Mattle HP, Nogueira RG, Siddiqui AH, Yavagal DR, Baxter BW, Devlin TG, Lopes DK, Reddy VK, du Mesnil de Rochemont R, Singer OC, Jahan R; SWIFT PRIME Investigators. Stent-retriever thrombectomy after intravenous t-PA vs. t-PA alone in stroke. N Engl J Med. 2015 Jun 11;372(24):2285-95. doi: 10.1056/NEJMoa1415061. Epub 2015 Apr 17.
- Wang Y, Xu J, Zhao X, Wang D, Wang C, Liu L, Wang A, Meng X, Li H, Wang Y. Association of hypertension with stroke recurrence depends on ischemic stroke subtype. Stroke. 2013 May;44(5):1232-7. doi: 10.1161/STROKEAHA.111.000302. Epub 2013 Feb 26.
- Xia CF, Yin H, Yao YY, Borlongan CV, Chao L, Chao J. Kallikrein protects against ischemic stroke by inhibiting apoptosis and inflammation and promoting angiogenesis and neurogenesis. Hum Gene Ther. 2006 Feb;17(2):206-19. doi: 10.1089/hum.2006.17.206.
- Yang P, Zhang Y, Zhang L, Zhang Y, Treurniet KM, Chen W, Peng Y, Han H, Wang J, Wang S, Yin C, Liu S, Wang P, Fang Q, Shi H, Yang J, Wen C, Li C, Jiang C, Sun J, Yue X, Lou M, Zhang M, Shu H, Sun D, Liang H, Li T, Guo F, Ke K, Yuan H, Wang G, Yang W, Shi H, Li T, Li Z, Xing P, Zhang P, Zhou Y, Wang H, Xu Y, Huang Q, Wu T, Zhao R, Li Q, Fang Y, Wang L, Lu J, Li Y, Fu J, Zhong X, Wang Y, Wang L, Goyal M, Dippel DWJ, Hong B, Deng B, Roos YBWEM, Majoie CBLM, Liu J; DIRECT-MT Investigators. Endovascular Thrombectomy with or without Intravenous Alteplase in Acute Stroke. N Engl J Med. 2020 May 21;382(21):1981-1993. doi: 10.1056/NEJMoa2001123. Epub 2020 May 6.
- 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.
- Pan Y, Li Z, Li J, Jin A, Lin J, Jing J, Li H, Meng X, Wang Y, Wang Y. Residual Risk and Its Risk Factors for Ischemic Stroke with Adherence to Guideline-Based Secondary Stroke Prevention. J Stroke. 2021 Jan;23(1):51-60. doi: 10.5853/jos.2020.03391. Epub 2021 Jan 31.
- Asadi H, Dowling R, Yan B, Wong S, Mitchell P. Advances in endovascular treatment of acute ischaemic stroke. Intern Med J. 2015 Aug;45(8):798-805. doi: 10.1111/imj.12652.
- Zi W, Qiu Z, Li F, Sang H, Wu D, Luo W, Liu S, Yuan J, Song J, Shi Z, Huang W, Zhang M, Liu W, Guo Z, Qiu T, Shi Q, Zhou P, Wang L, Fu X, Liu S, Yang S, Zhang S, Zhou Z, Huang X, Wang Y, Luo J, Bai Y, Zhang M, Wu Y, Zeng G, Wan Y, Wen C, Wen H, Ling W, Chen Z, Peng M, Ai Z, Guo F, Li H, Guo J, Guan H, Wang Z, Liu Y, Pu J, Wang Z, Liu H, Chen L, Huang J, Yang G, Gong Z, Shuai J, Nogueira RG, Yang Q; DEVT Trial Investigators. Effect of Endovascular Treatment Alone vs Intravenous Alteplase Plus Endovascular Treatment on Functional Independence in Patients With Acute Ischemic Stroke: The DEVT Randomized Clinical Trial. JAMA. 2021 Jan 19;325(3):234-243. doi: 10.1001/jama.2020.23523.
- Wang H, Zi W, Hao Y, Yang D, Shi Z, Lin M, Wang S, Liu W, Wang Z, Liu X, Guo F, Liu Y, Xu G, Xiong Y, Liu X; ACTUAL Investigators. Direct endovascular treatment: an alternative for bridging therapy in anterior circulation large-vessel occlusion stroke. Eur J Neurol. 2017 Jul;24(7):935-943. doi: 10.1111/ene.13311. Epub 2017 May 11.
- Ye Q, Zhai F, Chao B, Cao L, Xu Y, Zhang P, Han H, Wang L, Xu B, Chen W, Wen C, Wang S, Wang R, Zhang L, Jiao L, Liu S, Zhu YC, Wang LD. Rates of intravenous thrombolysis and endovascular therapy for acute ischaemic stroke in China between 2019 and 2020. Lancet Reg Health West Pac. 2022 Feb 22;21:100406. doi: 10.1016/j.lanwpc.2022.100406. eCollection 2022 Apr.
- Shen H, Killingsworth MC, Bhaskar SMM. Comprehensive Meta-Analysis of Futile Recanalization in Acute Ischemic Stroke Patients Undergoing Endovascular Thrombectomy: Prevalence, Factors, and Clinical Outcomes. Life (Basel). 2023 Sep 26;13(10):1965. doi: 10.3390/life13101965.
- Wang A, Jia B, Zhang X, Huo X, Chen J, Gui L, Cai Y, Guo Z, Han Y, Peng Z, Jing P, Chen Y, Liu Y, Yang Y, Wang F, Sun Z, Li T, Sun H, Yuan H, Shao H, Gao L, Zhang P, Wang F, Cao X, Shi W, Li C, Yang J, Zhang H, Wang F, Deng J, Liu Y, Deng W, Song C, Chen H, He L, Zhao H, Li X, Yang H, Zhou Z, Wang Y, Miao Z; BAST Investigators. Efficacy and Safety of Butylphthalide in Patients With Acute Ischemic Stroke: A Randomized Clinical Trial. JAMA Neurol. 2023 Aug 1;80(8):851-859. doi: 10.1001/jamaneurol.2023.1871.
- Ling L, Hou Q, Xing S, Yu J, Pei Z, Zeng J. Exogenous kallikrein enhances neurogenesis and angiogenesis in the subventricular zone and the peri-infarction region and improves neurological function after focal cortical infarction in hypertensive rats. Brain Res. 2008 Apr 24;1206:89-97. doi: 10.1016/j.brainres.2008.01.099. Epub 2008 Mar 19.
- Miao J, Deng F, Zhang Y, Xie HY, Feng JC. Exogenous human urinary kallidinogenase increases cerebral blood flow in patients with acute ischemic stroke. Neurosciences (Riyadh). 2016 Apr;21(2):126-30. doi: 10.17712/nsj.2016.2.20150581.
- Li J, Chen Y, Zhang X, Zhang B, Zhang M, Xu Y. Human Urinary Kallidinogenase Improves Outcome of Stroke Patients by Shortening Mean Transit Time of Perfusion Magnetic Resonance Imaging. J Stroke Cerebrovasc Dis. 2015 Aug;24(8):1730-7. doi: 10.1016/j.jstrokecerebrovasdis.2015.03.032. Epub 2015 Jun 29.
- Zhang C, Tao W, Liu M, Wang D. Efficacy and safety of human urinary kallidinogenase injection for acute ischemic stroke: a systematic review. J Evid Based Med. 2012 Feb;5(1):31-9. doi: 10.1111/j.1756-5391.2012.01167.x.
- Huang Y, Wang B, Zhang Y, Wang P, Zhang X. Efficacy and safety of human urinary kallidinogenase for acute ischemic stroke: a meta-analysis. J Int Med Res. 2020 Sep;48(9):300060520943452. doi: 10.1177/0300060520943452.
- Wang YD, Lu RY, Huang XX, Yuan F, Hu T, Peng Y, Huang SQ. Human tissue kallikrein promoted activation of the ipsilesional sensorimotor cortex after acute cerebral infarction. Eur Neurol. 2011;65(4):208-14. doi: 10.1159/000325735. Epub 2011 Mar 22.
- Yan X, Chen H, Shang X. Human urinary kallidinogenase decreases the incidence of post-stroke cognitive impairment in acute ischemic stroke patients. J Integr Neurosci. 2022 Apr 8;21(3):80. doi: 10.31083/j.jin2103080.
- Han D, Chen X, Li D, Liu S, Lyu Y, Feng J. Human Urinary Kallidinogenase decreases recurrence risk and promotes good recovery. Brain Behav. 2018 Aug;8(8):e01033. doi: 10.1002/brb3.1033. Epub 2018 Jul 20.
- Wu J, Wu J, Wang L, Liu J. Urinary Kallidinogenase plus rt-PA Intravenous Thrombolysis for Acute Ischemic Stroke: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Comput Math Methods Med. 2022 May 17;2022:1500669. doi: 10.1155/2022/1500669. eCollection 2022.
- Berkhemer OA, Fransen PS, Beumer D, van den Berg LA, Lingsma HF, Yoo AJ, Schonewille WJ, Vos JA, Nederkoorn PJ, Wermer MJ, van Walderveen MA, Staals J, Hofmeijer J, van Oostayen JA, Lycklama a Nijeholt GJ, Boiten J, Brouwer PA, Emmer BJ, de Bruijn SF, van Dijk LC, Kappelle LJ, Lo RH, van Dijk EJ, de Vries J, de Kort PL, van Rooij WJ, van den Berg JS, van Hasselt BA, Aerden LA, Dallinga RJ, Visser MC, Bot JC, Vroomen PC, Eshghi O, Schreuder TH, Heijboer RJ, Keizer K, Tielbeek AV, den Hertog HM, Gerrits DG, van den Berg-Vos RM, Karas GB, Steyerberg EW, Flach HZ, Marquering HA, Sprengers ME, Jenniskens SF, Beenen LF, van den Berg R, Koudstaal PJ, van Zwam WH, Roos YB, van der Lugt A, van Oostenbrugge RJ, Majoie CB, Dippel DW; MR CLEAN Investigators. A randomized trial of intraarterial treatment for acute ischemic stroke. N Engl J Med. 2015 Jan 1;372(1):11-20. doi: 10.1056/NEJMoa1411587. Epub 2014 Dec 17.
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Aktuální)
Začátek studia
21. dubna 2025
Primární dokončení (Odhadovaný)
Primární dokončení
1. prosince 2026
Dokončení studie (Odhadovaný)
Dokončení studie
1. prosince 2027
Termíny zápisu do studia
První předloženo
První předloženo
20. února 2025
První předloženo, které splnilo kritéria kontroly kvality
První předloženo, které splnilo kritéria kontroly kvality
22. února 2025
První zveřejněno (Aktuální)
První zveřejněno
27. února 2025
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Poslední zveřejněná aktualizace
21. září 2026
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
18. září 2026
Naposledy ověřeno
Naposledy ověřeno
1. září 2026
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
Další identifikační čísla studie
- KY2024-320-04
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
NE
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Ne
Studuje produkt zařízení regulovaný americkým úřadem FDA
Ne
produkt vyrobený a vyvážený z USA
Ne
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .