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. 2018 Aug 21;8(8):CD010995.
doi: 10.1002/14651858.CD010995.pub2.

Recanalisation therapies for wake-up stroke

Melinda B Roaldsen  1 , Haakon Lindekleiv, Ellisiv B Mathiesen, Eivind Berge
Affiliations

Recanalisation therapies for wake-up stroke

Melinda B Roaldsen et al. Cochrane Database Syst Rev. .

Update in

Abstract

Background: About one in five strokes occur during sleep (wake-up stroke). People with wake-up strokes have traditionally been considered ineligible for thrombolytic treatment because the time of stroke onset is unknown. However, some studies suggest that these people may benefit from recanalisation therapies.

Objectives: To assess the effects of intravenous thrombolysis and other recanalisation therapies versus control in people with acute ischaemic stroke presenting on awakening.

Search methods: We searched the Cochrane Stroke Group Trials Register (last search: 9 January 2018). In addition, we searched the following electronic databases in December 2017: Cochrane Central Register of Controlled Trials (CENTRAL; 2017, Issue 11) in the Cochrane Library, MEDLINE, Embase, US National Institutes of Health Ongoing Trials Register ClinicalTrials.gov, World Health Organization International Clinical Trials Registry Platform (WHO ICTRP), the ISRCTN registry, and Stroke Trials Registry. We also screened references lists of relevant trials, contacted trialists, undertook forward tracking of relevant references, and contacted manufacturers of relevant devices and equipment.

Selection criteria: Randomised controlled trials of intravenous thrombolytic drugs or intra-arterial therapies in people with acute ischaemic stroke presenting upon awakening.

Data collection and analysis: Two review authors applied the inclusion criteria, extracted data, and assessed trial quality and risk of bias using the GRADE approach. We obtained both published and unpublished data.

Main results: We included one pilot trial with nine participants. The trial was a feasibility trial that included participants with an unknown onset of stroke and signs on perfusion computed tomography of ischaemic tissue at risk of infarction, who were randomised to alteplase (0.9 mg/kg) or placebo. One trial was prematurely terminated due to signs of efficacy of the intervention arm; we did not include this trial because we were not able to obtain data for the portion of the participants with wake-up stroke after requesting this information from the trial authors. We identified six ongoing trials.

Authors' conclusions: There is insufficient evidence from randomised controlled trials for recommendations concerning recanalisation therapies for wake-up stroke. Results from ongoing trials will hopefully establish the efficacy and safety of such therapies.

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Conflict of interest statement

MBR: none known HL: none known EBM: none known EB: none known

Figures

1
1
PRISMA flow diagram.
2
2
Risk of bias summary: judgements about each risk of bias item for the included study.
See this image and copyright information in PMC

References

References to studies included in this review

Michel 2012 {published and unpublished data}
    1. Michel P, Ntaios G, Reichhart M, Schindler C, Bogousslavsky J, Maeder P, et al. Perfusion‐CT guided intravenous thrombolysis in patients with unknown‐onset stroke: a randomized, double‐blind, placebo‐controlled, pilot feasibility trial. Neuroradiology 2012;54:579‐88. - PubMed

References to studies excluded from this review

NCT02142283 {published data only}
    1. NCT02142283. Clinical mismatch in the triage of wake up and late presenting strokes undergoing neurointervention with Trevo (DAWN). clinicaltrials.gov/ct2/show/NCT02142283 (first received 20 May 2014).

References to ongoing studies

NCT01455935 {published data only}
    1. NCT01455935. Wake up symptomatic stroke ‐ benefit of intravenous clot busters or endovascular intervention (WASSABI). clinicaltrials.gov/ct2/show/NCT01455935 (first received 20 October 2011).
NCT01525290 {published data only}
    1. NCT01525290. Efficacy and safety of MRI‐based thrombolysis in wake‐up stroke (WAKE‐UP). clinicaltrials.gov/ct2/show/NCT01525290 (first received 2 February 2012).
NCT01580839 {published data only}
    1. NCT01580839. EXTEND (International): Extending the Time for Thrombolysis in Emergency Neurological Deficits (International) (EXTEND). clinicaltrials.gov/ct2/show/NCT01580839 (first received 19 April 2012).
NCT01852201 {published data only}
    1. NCT01852201. POSITIVE Stroke Clinical Trial. clinicaltrials.gov/ct2/show/NCT01852201 (first received 13 May 2013).
NCT02002325 {published data only}
    1. NCT02002325. THrombolysis for Acute Wake‐up and unclear‐onset Strokes with alteplase at 0.6 mg/kg trial (THAWS). clinicaltrials.gov/ct2/show/NCT02002325 (first received 5 December 2013).
NCT03181360 {published and unpublished data}
    1. NCT03181360. Tenecteplase in Wake‐up Ischaemic Stroke Trial (TWIST). clinicaltrials.gov/ct2/show/NCT03181360 (first received 8 June 2017).

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References to other published versions of this review

Lindekleiv 2014
    1. Lindekleiv H, Mathiesen EB, Berge E. Recanalisation therapies for wake‐up stroke. Cochrane Database of Systematic Reviews 2014, Issue 3. [DOI: 10.1002/14651858.CD010995] - DOI - PMC - PubMed

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