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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.


ABSTRACT:

Background

Endovascular 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.

Methods

MR CLEAN-NO IV is a multicenter randomized open-label clinical trial with blinded outcome assessment (PROBE design). Patients ??18?years of age with a pre-stroke mRS 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 registration

www.isrctn.com : ISRCTN80619088 . Registered on 31 October 2017.

SUBMITTER: Treurniet KM 

PROVIDER: S-EPMC7885482 | biostudies-literature | 2021 Feb

REPOSITORIES: biostudies-literature

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Publications

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.

Treurniet Kilian M KM   LeCouffe Natalie E NE   Kappelhof Manon M   Emmer Bart J BJ   van Es Adriaan C G M ACGM   Boiten Jelis J   Lycklama Geert J GJ   Keizer Koos K   Yo Lonneke S F LSF   Lingsma Hester F HF   van Zwam Wim H WH   de Ridder Inger I   van Oostenbrugge Robert J RJ   van der Lugt Aad A   Dippel Diederik W J DWJ   Coutinho Jonathan M JM   Roos Yvo B W E M YBWEM   Majoie Charles B L M CBLM  

Trials 20210215 1


<h4>Background</h4>Endovascular 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.<h4>Methods</h4>M  ...[more]

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