The Efficacy and Safety of Tirofiban Enhanced Antiplatelet Therapy in the Treatment of Ruptured Intracranial Aneurysms With Stent

Summary

This multicenter prospective randomized controlled study will enroll patients with ruptured intracranial aneurysms receiving stent-assisted coiling across multiple Chinese medical centers. The investigators aim to evaluate the efficacy and safety of tirofiban-enhanced antiplatelet therapy versus conventional dual antiplatelet treatment on the 90-day neurological prognosis and major adverse cerebrovascular events of enrolled subjects.

Timeline

Start

2026-09-01

Primary completion

2028-09-30

Completion

2028-12-31

Publications

• Results Liang XD, Wang ZL, Li TX, He YK, Bai WX, Wang YY, Zhou GY. Safety and efficacy of a new prophylactic tirofiban protocol without oral intraoperative antiplatelet therapy for endovascular treatment of ruptured intracranial aneurysms. J Neurointerv Surg. 2016 Nov;8(11):1148-1153. doi: 10.1136/neurintsurg-2015-012055. Epub 2015 Nov 27.
• Results Reddy D, Fallah A, Petropoulos JA, Farrokhyar F, Macdonald RL, Jichici D. Prophylactic magnesium sulfate for aneurysmal subarachnoid hemorrhage: a systematic review and meta-analysis. Neurocrit Care. 2014 Oct;21(2):356-64. doi: 10.1007/s12028-014-9964-0.
• Results Jeon JS, Sheen SH, Hwang G, Kang SH, Heo DH, Cho YJ. Intravenous magnesium infusion for the prevention of symptomatic cerebral vasospasm after aneurysmal subarachnoid hemorrhage. J Korean Neurosurg Soc. 2012 Aug;52(2):75-9. doi: 10.3340/jkns.2012.52.2.75. Epub 2012 Aug 31.
• Results Vergouwen MD, de Haan RJ, Vermeulen M, Roos YB. Effect of statin treatment on vasospasm, delayed cerebral ischemia, and functional outcome in patients with aneurysmal subarachnoid hemorrhage: a systematic review and meta-analysis update. Stroke. 2010 Jan;41(1):e47-52. doi: 10.1161/STROKEAHA.109.556332. Epub 2009 Oct 29.
• Results Shen J, Huang KY, Zhu Y, Pan JW, Jiang H, Weng YX, Zhan RY. Effect of statin treatment on vasospasm-related morbidity and functional outcome in patients with aneurysmal subarachnoid hemorrhage: a systematic review and meta-analysis. J Neurosurg. 2017 Aug;127(2):291-301. doi: 10.3171/2016.5.JNS152900. Epub 2016 Oct 7.
• Results Togashi K, Joffe AM, Sekhar L, Kim L, Lam A, Yanez D, Broeckel-Elrod JA, Moore A, Deem S, Khandelwal N, Souter MJ, Treggiari MM. Randomized pilot trial of intensive management of blood pressure or volume expansion in subarachnoid hemorrhage (IMPROVES). Neurosurgery. 2015 Feb;76(2):125-34; discussion 134-5; quiz 135. doi: 10.1227/NEU.0000000000000592.
• Results Loan JJM, Wiggins AN, Brennan PM. Medically induced hypertension, hypervolaemia and haemodilution for the treatment and prophylaxis of vasospasm following aneurysmal subarachnoid haemorrhage: systematic review. Br J Neurosurg. 2018 Apr;32(2):157-164. doi: 10.1080/02688697.2018.1426720. Epub 2018 Jan 17.
• Results Choudhari K. Prophylactic hyperdynamic postoperative fluid therapy after aneurysmal subarachnoid hemorrhage: a clinical, prospective, randomized, controlled study. Neurosurgery. 2002 May;50(5):1170-1; author reply 1171-2. doi: 10.1097/00006123-200205000-00057. No abstract available.
• Results Lennihan L, Mayer SA, Fink ME, Beckford A, Paik MC, Zhang H, Wu YC, Klebanoff LM, Raps EC, Solomon RA. Effect of hypervolemic therapy on cerebral blood flow after subarachnoid hemorrhage : a randomized controlled trial. Stroke. 2000 Feb;31(2):383-91. doi: 10.1161/01.str.31.2.383.
• Results Tejada JG, Taylor RA, Ugurel MS, Hayakawa M, Lee SK, Chaloupka JC. Safety and feasibility of intra-arterial nicardipine for the treatment of subarachnoid hemorrhage-associated vasospasm: initial clinical experience with high-dose infusions. AJNR Am J Neuroradiol. 2007 May;28(5):844-8.
• Results Stuart RM, Helbok R, Kurtz P, Schmidt M, Fernandez L, Lee K, Badjatia N, Mayer SA, Lavine S, Meyers P, Connolly ES, Claassen J. High-dose intra-arterial verapamil for the treatment of cerebral vasospasm after subarachnoid hemorrhage: prolonged effects on hemodynamic parameters and brain metabolism. Neurosurgery. 2011 Feb;68(2):337-45; discussion 345. doi: 10.1227/NEU.0b013e318201be47.
• Results Shankar JJ, dos Santos MP, Deus-Silva L, Lum C. Angiographic evaluation of the effect of intra-arterial milrinone therapy in patients with vasospasm from aneurysmal subarachnoid hemorrhage. Neuroradiology. 2011 Feb;53(2):123-8. doi: 10.1007/s00234-010-0720-7. Epub 2010 Jun 5.
• Results Linfante I, Delgado-Mederos R, Andreone V, Gounis M, Hendricks L, Wakhloo AK. Angiographic and hemodynamic effect of high concentration of intra-arterial nicardipine in cerebral vasospasm. Neurosurgery. 2008 Dec;63(6):1080-6; discussion 1086-7. doi: 10.1227/01.NEU.0000327698.66596.35.
• Results Fraticelli AT, Cholley BP, Losser MR, Saint Maurice JP, Payen D. Milrinone for the treatment of cerebral vasospasm after aneurysmal subarachnoid hemorrhage. Stroke. 2008 Mar;39(3):893-8. doi: 10.1161/STROKEAHA.107.492447. Epub 2008 Jan 31.
• Results Feng L, Fitzsimmons BF, Young WL, Berman MF, Lin E, Aagaard BD, Duong H, Pile-Spellman J. Intraarterially administered verapamil as adjunct therapy for cerebral vasospasm: safety and 2-year experience. AJNR Am J Neuroradiol. 2002 Sep;23(8):1284-90.
• Results Badjatia N, Topcuoglu MA, Pryor JC, Rabinov JD, Ogilvy CS, Carter BS, Rordorf GA. Preliminary experience with intra-arterial nicardipine as a treatment for cerebral vasospasm. AJNR Am J Neuroradiol. 2004 May;25(5):819-26.
• Results Al-Mufti F, Amuluru K, Damodara N, Dodson V, Roh D, Agarwal S, Meyers PM, Connolly ES Jr, Schmidt MJ, Claassen J, Park S. Admission neutrophil-lymphocyte ratio predicts delayed cerebral ischemia following aneurysmal subarachnoid hemorrhage. J Neurointerv Surg. 2019 Nov;11(11):1135-1140. doi: 10.1136/neurintsurg-2019-014759. Epub 2019 Apr 12.
• Results Aoki R, Shimoda M, Oda S, Imai M, Shigematsu H, Matsumae M. Clinical Significance of the CSF Pulsation Flow Sign in the Foramen of Monro on FLAIR in Patients with Aneurysmal SAH -Preliminary Report. Neurol Med Chir (Tokyo). 2019 Jul 15;59(7):271-280. doi: 10.2176/nmc.oa.2018-0294. Epub 2019 May 9.
• Results Schmidt JM, Wartenberg KE, Fernandez A, Claassen J, Rincon F, Ostapkovich ND, Badjatia N, Parra A, Connolly ES, Mayer SA. Frequency and clinical impact of asymptomatic cerebral infarction due to vasospasm after subarachnoid hemorrhage. J Neurosurg. 2008 Dec;109(6):1052-9. doi: 10.3171/JNS.2008.109.12.1052.
• Results Rabinstein AA, Friedman JA, Weigand SD, McClelland RL, Fulgham JR, Manno EM, Atkinson JL, Wijdicks EF. Predictors of cerebral infarction in aneurysmal subarachnoid hemorrhage. Stroke. 2004 Aug;35(8):1862-6. doi: 10.1161/01.STR.0000133132.76983.8e. Epub 2004 Jun 24.
• Results Vergouwen MD, Vermeulen M, van Gijn J, Rinkel GJ, Wijdicks EF, Muizelaar JP, Mendelow AD, Juvela S, Yonas H, Terbrugge KG, Macdonald RL, Diringer MN, Broderick JP, Dreier JP, Roos YB. Definition of delayed cerebral ischemia after aneurysmal subarachnoid hemorrhage as an outcome event in clinical trials and observational studies: proposal of a multidisciplinary research group. Stroke. 2010 Oct;41(10):2391-5. doi: 10.1161/STROKEAHA.110.589275. Epub 2010 Aug 26.
• Results Macdonald RL, Hunsche E, Schuler R, Wlodarczyk J, Mayer SA. Quality of life and healthcare resource use associated with angiographic vasospasm after aneurysmal subarachnoid hemorrhage. Stroke. 2012 Apr;43(4):1082-8. doi: 10.1161/STROKEAHA.111.634071. Epub 2012 Feb 9.
• Results Ten Brinck MFM, de Vries J, Bartels RHMA, Grotenhuis JA, Boogaarts HD. NeuroForm Atlas Stent-Assisted Coiling: Preliminary Results. Neurosurgery. 2019 Jan 1;84(1):179-189. doi: 10.1093/neuros/nyy048.
• Results Nishido H, Piotin M, Bartolini B, Pistocchi S, Redjem H, Blanc R. Analysis of complications and recurrences of aneurysm coiling with special emphasis on the stent-assisted technique. AJNR Am J Neuroradiol. 2014 Feb;35(2):339-44. doi: 10.3174/ajnr.A3658. Epub 2013 Aug 1.
• Results Shen G, Jia Z, Zhao L, Lu G, Liu S, Shi H. The safety and efficacy of a low dose of tirofiban for early complications during and after stent-assisted coiling of ruptured intracranial aneurysms: A propensity matching study. Clin Neurol Neurosurg. 2022 Mar;214:107132. doi: 10.1016/j.clineuro.2022.107132. Epub 2022 Jan 15.
• Results Ma Y, Jia C, Zhang T, Feng Y, Chen X, Zhao W. Safety and efficacy of intravenous tirofiban for stent-assisted coiling in acutely ruptured intracranial aneurysms: A single center experience. Interv Neuroradiol. 2022 Aug;28(4):476-481. doi: 10.1177/15910199211042463. Epub 2021 Sep 13.
• Results Zanaty M, Allan L, Samaniego EA, Piscopo A, Ryan E, Torner JC, Hasan D. Phase 1/2a Trial of ISPASM. Stroke. 2021 Dec;52(12):3750-3758. doi: 10.1161/STROKEAHA.121.034578. Epub 2021 Sep 2.
• Results Yoon CH, Lee HW, Kim YS, Lee SW, Yeom JA, Roh J, Baik SK. Preliminary Study of Tirofiban Infusion in Coil Embolization of Ruptured Intracranial Aneurysms. Neurosurgery. 2018 Jan 1;82(1):76-84. doi: 10.1093/neuros/nyx177.
• Results Tantry US, Gurbel PA. Antiplatelet drug resistance and variability in response: the role of antiplatelet therapy monitoring. Curr Pharm Des. 2013;19(21):3795-815. doi: 10.2174/1381612811319210006.
• Results Yang H, Li Y, Jiang Y. Insufficient platelet inhibition and thromboembolic complications in patients with intracranial aneurysms after stent placement. J Neurosurg. 2016 Aug;125(2):247-53. doi: 10.3171/2015.6.JNS1511. Epub 2015 Nov 20.
• Results King B, Vaziri S, Singla A, Fargen KM, Mocco J. Clinical and angiographic outcomes after stent-assisted coiling of cerebral aneurysms with Enterprise and Neuroform stents: a comparative analysis of the literature. J Neurointerv Surg. 2015 Dec;7(12):905-9. doi: 10.1136/neurintsurg-2014-011457. Epub 2014 Oct 28.
• Results Zi W, Song J, Kong W, Huang J, Guo C, He W, Yu Y, Zhang B, Geng W, Tan X, Tian Y, Liu Z, Cao M, Cheng D, Li B, Huang W, Liu J, Wang P, Yu Z, Liang H, Yang S, Tang M, Liu W, Huang X, Liu S, Tang Y, Wu Y, Yao L, Shi Z, He P, Zhao H, Chen Z, Luo J, Wan Y, Shi Q, Wang M, Yang D, Chen X, Huang F, Mu J, Li H, Li Z, Zheng J, Xie S, Cai T, Peng Y, Xie W, Qiu Z, Liu C, Yue C, Li L, Tian Y, Yang D, Miao J, Yang J, Hu J, Nogueira RG, Wang D, Saver JL, Li F, Yang Q; RESCUE BT2 Investigators. Tirofiban for Stroke without Large or Medium-Sized Vessel Occlusion. N Engl J Med. 2023 Jun 1;388(22):2025-2036. doi: 10.1056/NEJMoa2214299.

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Indications