MR CLEAN, a multicenter randomized clinical trial of endovascular treatment for acute ischemic stroke in the Netherlands: study protocol for a randomized controlled trial

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• 作者：Puck SS Fransen ; Debbie Beumer ; Olvert A Berkhemer ; Lucie A van den Berg…
• 关键词：Alteplase ; Urokinase ; Endovascular treatment ; Acute ischemic stroke ; Randomized controlled trial ; Stent ; Thrombectomy
• 刊名：Trials
• 出版年：2014
• 出版时间：December 2014
• 年：2014
• 卷：15
• 期：1
• 全文大小：1,321 KB
• 参考文献：1. Wardlaw, JM, Murray, V, Berge, E, Del, ZG, Sandercock, P, Lindley, RL, Cohen, G (2012) Recombinant tissue plasminogen activator for acute ischaemic stroke: an updated systematic review and meta-analysis. Lancet 379: pp. 2364-2372 CrossRef
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  3. Lees, KR, Bluhmki, E, Von Kummer, R, Brott, TG, Toni, D, Grotta, JC, Albers, GW, Kaste, M, Marler, JR, Hamilton, SA, Tilley, BC, Davis, SM, Donnan, GA, Hacke, W, Allen, K, Mau, J, Meier, D, Del Zoppo, G, De Silva, DA, Butcher, KS, Parsons, MW, Barber, PA, Levi, C, Bladin, C, Byrnes, G (2010) Time to treatment with intravenous alteplase and outcome in stroke: an updated pooled analysis of ECASS, ATLANTIS, NINDS, and EPITHET trials. Lancet 375: pp. 1695-1703 CrossRef
  4. Beumer, DSG, Fonvile, S, Van Oostenbrugge, RJ, Homburg, PJ, Van der Lugt, A, Dippel, DWJ (2013) Intra-arterial occlusion in acute ischemic stroke: relative frequency in an unselected population. Cerebrovasc Dis 35: pp. 66
  5. Derex, L, Nighoghossian, N, Hermier, M, Adeleine, P, Froment, JC, Trouillas, P (2002) Early detection of cerebral arterial occlusion on magnetic resonance angiography: predictive value of the baseline NIHSS score and impact on neurological outcome. Cerebrovasc Dis 13: pp. 225-229 CrossRef
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  10. Ogawa, A, Mori, E, Minematsu, K, Taki, W, Takahashi, A, Nemoto, S, Miyamoto, S, Sasaki, M, Inoue, T (2007) Randomized trial of intraarterial infusion of urokinase within 6?hours of middle cerebral artery stroke: the middle cerebral artery embolism local fibrinolytic intervention trial (MELT) Japan. Stroke 38: pp. 2633-2639 CrossRef
  11. Broderick, JP, Palesch, YY, Demchuk, AM, Yeatts, SD, Khatri, P, Hill, MD, Jauch, EC, Jovin, TG, Yan, B, Silver, FL, Von Kummer, R, Molina, CA, Demaerschalk, BM, Budzik, R, Clark, WM, Zaidat, OO, Malisch, TW, Goyal, M, Schonewille, WJ, Mazighi, M, Engelter, ST, Anderson, C, Spilker, J, Carrozzella, J, Ryckborst, KJ, Janis, LS, Martin, RH, Foster, LD, Tomsick, TA (2013) Endovascular therapy after intravenous t-PA versus t-PA alone for stroke. N Engl J Med 368: pp. 893-903 CrossRef
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• 刊物主题：Medicine/Public Health, general; Biomedicine general; Statistics for Life Sciences, Medicine, Health Sciences;
• 出版者：BioMed Central
• ISSN：1745-6215

文摘

Background Endovascular or intra-arterial treatment (IAT) increases the likelihood of recanalization in patients with acute ischemic stroke caused by a proximal intracranial arterial occlusion. However, a beneficial effect of IAT on functional recovery in patients with acute ischemic stroke remains unproven. The aim of this study is to assess the effect of IAT on functional outcome in patients with acute ischemic stroke. Additionally, we aim to assess the safety of IAT, and the effect on recanalization of different mechanical treatment modalities. Methods/design A multicenter randomized clinical trial with blinded outcome assessment. The active comparison is IAT versus no IAT. IAT may consist of intra-arterial thrombolysis with alteplase or urokinase, mechanical treatment or both. Mechanical treatment refers to retraction, aspiration, sonolysis, or use of a retrievable stent (stent-retriever). Patients with a relevant intracranial proximal arterial occlusion of the anterior circulation, who can be treated within 6?hours after stroke onset, are eligible. Treatment effect will be estimated with ordinal logistic regression (shift analysis); 500 patients will be included in the trial for a power of 80% to detect a shift leading to a decrease in dependency in 10% of treated patients. The primary outcome is the score on the modified Rankin scale at 90?days. Secondary outcomes are the National Institutes of Health stroke scale score at 24?hours, vessel patency at 24?hours, infarct size on day 5, and the occurrence of major bleeding during the first 5?days. Discussion If IAT leads to a 10% absolute reduction in poor outcome after stroke, careful implementation of the intervention could save approximately 1% of all new stroke cases from death or disability annually. Trial registration NTR1804 (7 May 2009)/ISRCTN10888758 (24 July 2012).