MR CLEAN-NO IV: intravenous treatment followed by endovascular treatment versus direct endovascular treatment for acute ischemic stroke caused by a proximal intracranial occlusion-study protocol for a randomized clinical trial

被引：48

作者：

Treurniet, Kilian M. ^{[1
]}

LeCouffe, Natalie E. ^{[1
,2
]}

Kappelhof, Manon ^{[1
]}

Emmer, Bart J. ^{[1
]}

van Es, Adriaan C. G. M. ^{[3
]}

Boiten, Jelis ^{[4
]}

Lycklama, Geert J. ^{[5
]}

Keizer, Koos ^{[6
]}

Yo, Lonneke S. F. ^{[7
]}

Lingsma, Hester F. ^{[8
]}

van Zwam, Wim H. ^{[9
]}

de Ridder, Inger ^{[10
]}

van Oostenbrugge, Robert J. ^{[10
]}

van der Lugt, Aad ^{[11
]}

Dippel, Diederik W. J. ^{[12
]}

Coutinho, Jonathan M. ^{[2
]}

Roos, Yvo B. W. E. M. ^{[2
]}

Majoie, Charles B. L. M. ^{[1
]}

机构：

[1] Univ Amsterdam, Dept Radiol & Nucl Med, Amsterdam UMC, POB 22660, NL-1100 DD Amsterdam, Netherlands

[2] Univ Amsterdam, Dept Neurol, Amsterdam UMC, Amsterdam, Netherlands

[3] Leiden Univ, Dept Radiol, Med Ctr, Leiden, Netherlands

[4] Haaglanden Med Ctr, Dept Neurol, The Hague, Netherlands

[5] The Hague Med Ctr, Dept Radiol, The Hague, Netherlands

[6] Catharina Hosp, Dept Neurol, Eindhoven, Netherlands

[7] Catharina Hosp, Dept Radiol, Eindhoven, Netherlands

[8] Erasmus MC, Dept Publ Hlth, Rotterdam, Netherlands

[9] Maastricht Univ, Dept Radiol, Med Ctr, Maastricht, Netherlands

[10] Maastricht Univ, Dept Neurol, Med Ctr, Maastricht, Netherlands

[11] Erasmus MC, Dept Radiol & Nucl Med, Rotterdam, Netherlands

[12] Erasmus MC, Dept Neurol, Rotterdam, Netherlands

来源：

TRIALS | 2021年 / 22卷 / 01期

关键词：

Intravenous alteplase; Endovascular treatment; Ischemic stroke; TISSUE-PLASMINOGEN ACTIVATOR; MECHANICAL THROMBECTOMY; ARTERY RECANALIZATION; DEFERRED CONSENT; INFORMED-CONSENT; ALTEPLASE; THROMBOLYSIS; ADJUSTMENT; EXPERIENCE; OUTCOMES;

D O I：

10.1186/s13063-021-05063-5

中图分类号：

R-3 [医学研究方法]; R3 [基础医学];

学科分类号：

1001 ;

摘要：

BackgroundEndovascular treatment (EVT) has greatly improved the prognosis of acute ischemic stroke (AIS) patients with a proximal intracranial large vessel occlusion (LVO) of the anterior circulation. Currently, there is clinical equipoise concerning the added benefit of intravenous alteplase administration (IVT) prior to EVT. The aim of this study is to assess the efficacy and safety of omitting IVT before EVT in patients with AIS caused by an anterior circulation LVO.MethodsMR CLEAN-NO IV is a multicenter randomized open-label clinical trial with blinded outcome assessment (PROBE design). Patients >= 18years of age with a pre-stroke mRS <3 with an LVO confirmed on CT angiography/MR angiography eligible for both IVT and EVT are randomized to receive either IVT (0.9mg/kg) followed by EVT, or direct EVT in a 1:1 ratio. The primary objective is to assess superiority of direct EVT. Secondarily, non-inferiority of direct EVT compared to IVT before EVT will be explored. The primary outcome is the score on the modified Rankin Scale at 90days. Ordinal regression with adjustment for prognostic variables will be used to estimate treatment effect. Secondary outcomes include reperfusion graded with the eTICI scale after EVT and stroke severity (National Institutes of Health Stroke Scale) at 24h. Safety outcomes include intracranial hemorrhages scored according to the Heidelberg criteria. A total of 540 patients will be included.DiscussionIVT prior to EVT might facilitate early reperfusion before EVT or improved reperfusion rates during EVT. Conversely, among other potential adverse effects, the increased risk of bleeding could nullify the beneficial effects of IVT. MR CLEAN-NO IV will provide insight into whether IVT is still of added value in patients eligible for EVT.Trial registrationwww.isrctn.com: ISRCTN80619088. Registered on 31 October 2017.

引用

页数：15

共 63 条

[1] Outcomes After Direct Thrombectomy or Combined Intravenous and Endovascular Treatment Are Not Different [J].

Abilleira, Sonia ;

Ribera, Aida ;

Cardona, Pedro ;

Rubiera, Marta ;

Lopez-Cancio, Elena ;

Amaro, Sergi ;

Rodriguez-Campello, Ana ;

Camps-Renom, Pol ;

Canovas, David ;

Angels de Miquel, Maria ;

Tomasello, Alejandro ;

Remollo, Sebastian ;

Lopez-Rueda, Antonio ;

Vivas, Elio ;

Perendreu, Joan ;

Gallofre, Miquel .

STROKE, 2017, 48 (02) :375-378

[2] Thrombus Migration Paradox in Patients With Acute Ischemic Stroke [J].

Alves, Heitor C. ;

Treurniet, Kilian M. ;

Jansen, Ivo G. H. ;

Yoo, Albert J. ;

Dutra, Bruna G. ;

Zhang, Guang ;

Yo, Lonneke ;

van Es, Adriaan C. G. M. ;

Emmer, Bart J. ;

van den Berg, Rene ;

van den Wijngaard, Ido R. ;

Nijeholt, Geert J. Lycklama a ;

Vos, Jan-Albert ;

Roos, Yvo B. W. E. M. ;

Schonewille, Wouter ;

Marquering, Henk A. ;

Majoie, Charles B. L. M. .

STROKE, 2019, 50 (11) :3156-3163

[3]

[Anonymous], DEF ROL AUTH CONTR

[4] Direct Mechanical Intervention Versus Bridging Therapy in Stroke Patients Eligible for Intravenous Thrombolysis A Pooled Analysis of 2 Registries [J].

Bellwald, Sebastian ;

Weber, Ralph ;

Dobrocky, Tomas ;

Nordmeyer, Hannes ;

Jung, Simon ;

Hadisurya, Jeffrie ;

Mordasini, Pasquale ;

Mono, Marie-Luise ;

Stracke, Christian P. ;

Sarikaya, Hakan ;

Bernasconi, Corrado ;

Berger, Klaus ;

Arnold, Marcel ;

Chapot, Rene ;

Gralla, Jan ;

Fischer, Urs .

STROKE, 2017, 48 (12) :3282-3288

[5]

Berkhemer OA, 2015, NEW ENGL J MED, V372, P394

[6] A Randomized Trial of Intraarterial Treatment for Acute Ischemic Stroke [J].

Berkhemer, O. A. ;

Fransen, P. S. S. ;

Beumer, D. ;

van den Berg, L. A. ;

Lingsma, H. F. ;

Yoo, A. J. ;

Schonewille, W. J. ;

Vos, J. A. ;

Nederkoorn, P. J. ;

Wermer, M. J. H. ;

van Walderveen, M. A. A. ;

Staals, J. ;

Hofmeijer, J. ;

van Oostayen, J. A. ;

Nijeholt, G. J. Lycklama A. ;

Boiten, J. ;

Brouwer, P. A. ;

Emmer, B. J. ;

de Bruijn, S. F. ;

van Dijk, L. C. ;

Kappelle, L. J. ;

Lo, R. H. ;

Van Dijk, E. J. ;

de Vries, J. ;

de Kort, P. L. M. ;

van Rooij, W. J. J. ;

van den Berg, J. S. P. ;

van Hasselt, B. A. A. M. ;

Aerden, L. A. M. ;

Dallinga, R. J. ;

Visser, M. C. ;

Bot, J. C. J. ;

Vroomen, P. C. ;

Eshghi, O. ;

Schreuder, T. H. C. M. L. ;

Heijboer, R. J. J. ;

Keizer, K. ;

Tielbeek, A. V. ;

den Hertog, H. M. ;

Gerrits, D. G. ;

van den Berg-Vos, R. M. ;

Karas, G. B. ;

Steyerberg, E. W. ;

Flach, H. Z. ;

Marquering, H. A. ;

Sprengers, M. E. S. ;

Jenniskens, S. F. M. ;

Beenen, L. F. M. ;

van den Berg, R. ;

Koudstaal, P. J. .

NEW ENGLAND JOURNAL OF MEDICINE, 2015, 372 (01) :11-20

[7] Low Rates of Acute Recanalization With Intravenous Recombinant Tissue Plasminogen Activator in Ischemic Stroke Real-World Experience and a Call for Action [J].

Bhatia, Rohit ;

Hill, Michael D. ;

Shobha, Nandavar ;

Menon, Bijoy ;

Bal, Simerpreet ;

Kochar, Puneet ;

Watson, Tim ;

Goyal, Mayank ;

Demchuk, Andrew M. .

STROKE, 2010, 41 (10) :2254-2258

[8] Automated Cerebral Infarct Volume Measurement in Follow-up Noncontrast CT Scans of Patients with Acute Ischemic Stroke [J].

Boers, A. M. ;

Marquering, H. A. ;

Jochem, J. J. ;

Besselink, N. J. ;

Berkhemer, O. A. ;

van der Lugt, A. ;

Beenen, L. F. ;

Majoie, C. B. .

AMERICAN JOURNAL OF NEURORADIOLOGY, 2013, 34 (08) :1522-1527

[9] Patients' evaluation of informed consent to postponed information: cohort study [J].

Boter, H ;

van Delden, JJM ;

de Haan, RJ ;

Rinkel, GJE .

BRITISH MEDICAL JOURNAL, 2004, 329 (7457) :86-86

[10] Modified informed consent procedure: consent to postponed information [J].

Boter, H ;

van Delden, JJM ;

de Haan, RJ ;

Rinkel, GJE .

BRITISH MEDICAL JOURNAL, 2003, 327 (7409) :284-285

← 1 2 3 4 5 6 7 →