The REstart or STop Antithrombotics Randomised Trial (RESTART) after stroke due to intracerebral haemorrhage: statistical analysis plan for a randomised controlled trial

Rustam Al-Shahi Salman; Gordon D Murray; Martin S Dennis; David E Newby; Peter A G Sandercock; Nikola Sprigg; Cathie L M Sudlow; David J Werring; Philip M White; William N Whiteley

doi:10.1186/s13063-019-3270-2

The REstart or STop Antithrombotics Randomised Trial (RESTART) after stroke due to intracerebral haemorrhage: statistical analysis plan for a randomised controlled trial

Rustam Al-Shahi Salman, Gordon D Murray, Martin S Dennis, David E Newby, Peter A G Sandercock, Nikola Sprigg, Cathie L M Sudlow, David J Werring, Philip M White, William N Whiteley

Research output: Contribution to journal › Article › peer-review

Abstract / Description of output

BACKGROUND: For adults surviving stroke due to spontaneous (non-traumatic) intracerebral haemorrhage (ICH) who had taken an antithrombotic (i.e. anticoagulant or antiplatelet) drug for the prevention of vaso-occlusive disease before the ICH, it is unclear whether starting antiplatelet therapy modifies the risks of recurrent ICH, major haemorrhagic events, major occlusive vascular events, or a composite of all major vascular events compared to avoiding antiplatelet therapy.

METHODS/DESIGN: The REstart or STop Antithrombotics Randomised Trial (RESTART) is an investigator-led, parallel group, open, assessor-blind, randomised trial comparing starting versus avoiding antiplatelet therapy for adults surviving antithrombotic-associated ICH. Recruitment began on 22 May 2013 and ended on 31 May 2018. Follow-up ended on 30 November 2018. This update to the protocol describes the statistical analysis plan (version 1.7, finalised on 25 January 2019). Database lock and un-blinding occurred on 29 January 2019, after which the un-masked trial statistician conducted the final analyses according to this statistical analysis plan.

DISCUSSION: Final results of RESTART will be analysed and disseminated in May 2019.

TRIAL REGISTRATION: ISRCTN registry 71907627 . Prospectively registered on 25 April 2013.

Original language	English
Pages (from-to)	183
Journal	Trials
Volume	20
Issue number	1
DOIs	https://doi.org/10.1186/s13063-019-3270-2
Publication status	Published - 25 Mar 2019

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RESTART Trial after stroke due to intracerebral haemorrhage - statistical analysis plan...
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Al-Shahi Salman, R., Murray, G. D., Dennis, M. S., Newby, D. E., Sandercock, P. A. G., Sprigg, N., Sudlow, C. L. M., Werring, D. J., White, P. M., & Whiteley, W. N. (2019). The REstart or STop Antithrombotics Randomised Trial (RESTART) after stroke due to intracerebral haemorrhage: statistical analysis plan for a randomised controlled trial. Trials, 20(1), 183. https://doi.org/10.1186/s13063-019-3270-2

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title = "The REstart or STop Antithrombotics Randomised Trial (RESTART) after stroke due to intracerebral haemorrhage: statistical analysis plan for a randomised controlled trial",

abstract = "BACKGROUND: For adults surviving stroke due to spontaneous (non-traumatic) intracerebral haemorrhage (ICH) who had taken an antithrombotic (i.e. anticoagulant or antiplatelet) drug for the prevention of vaso-occlusive disease before the ICH, it is unclear whether starting antiplatelet therapy modifies the risks of recurrent ICH, major haemorrhagic events, major occlusive vascular events, or a composite of all major vascular events compared to avoiding antiplatelet therapy.METHODS/DESIGN: The REstart or STop Antithrombotics Randomised Trial (RESTART) is an investigator-led, parallel group, open, assessor-blind, randomised trial comparing starting versus avoiding antiplatelet therapy for adults surviving antithrombotic-associated ICH. Recruitment began on 22 May 2013 and ended on 31 May 2018. Follow-up ended on 30 November 2018. This update to the protocol describes the statistical analysis plan (version 1.7, finalised on 25 January 2019). Database lock and un-blinding occurred on 29 January 2019, after which the un-masked trial statistician conducted the final analyses according to this statistical analysis plan.DISCUSSION: Final results of RESTART will be analysed and disseminated in May 2019.TRIAL REGISTRATION: ISRCTN registry 71907627 . Prospectively registered on 25 April 2013.",

author = "{Al-Shahi Salman}, Rustam and Murray, {Gordon D} and Dennis, {Martin S} and Newby, {David E} and Sandercock, {Peter A G} and Nikola Sprigg and Sudlow, {Cathie L M} and Werring, {David J} and White, {Philip M} and Whiteley, {William N}",

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doi = "10.1186/s13063-019-3270-2",

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Al-Shahi Salman, R , Murray, GD , Dennis, MS , Newby, DE, Sandercock, PAG, Sprigg, N, Sudlow, CLM, Werring, DJ, White, PM & Whiteley, WN 2019, 'The REstart or STop Antithrombotics Randomised Trial (RESTART) after stroke due to intracerebral haemorrhage: statistical analysis plan for a randomised controlled trial', Trials, vol. 20, no. 1, pp. 183. https://doi.org/10.1186/s13063-019-3270-2

TY - JOUR

T1 - The REstart or STop Antithrombotics Randomised Trial (RESTART) after stroke due to intracerebral haemorrhage

T2 - statistical analysis plan for a randomised controlled trial

AU - Al-Shahi Salman, Rustam

AU - Murray, Gordon D

AU - Dennis, Martin S

AU - Newby, David E

AU - Sandercock, Peter A G

AU - Sprigg, Nikola

AU - Sudlow, Cathie L M

AU - Werring, David J

AU - White, Philip M

AU - Whiteley, William N

PY - 2019/3/25

Y1 - 2019/3/25

N2 - BACKGROUND: For adults surviving stroke due to spontaneous (non-traumatic) intracerebral haemorrhage (ICH) who had taken an antithrombotic (i.e. anticoagulant or antiplatelet) drug for the prevention of vaso-occlusive disease before the ICH, it is unclear whether starting antiplatelet therapy modifies the risks of recurrent ICH, major haemorrhagic events, major occlusive vascular events, or a composite of all major vascular events compared to avoiding antiplatelet therapy.METHODS/DESIGN: The REstart or STop Antithrombotics Randomised Trial (RESTART) is an investigator-led, parallel group, open, assessor-blind, randomised trial comparing starting versus avoiding antiplatelet therapy for adults surviving antithrombotic-associated ICH. Recruitment began on 22 May 2013 and ended on 31 May 2018. Follow-up ended on 30 November 2018. This update to the protocol describes the statistical analysis plan (version 1.7, finalised on 25 January 2019). Database lock and un-blinding occurred on 29 January 2019, after which the un-masked trial statistician conducted the final analyses according to this statistical analysis plan.DISCUSSION: Final results of RESTART will be analysed and disseminated in May 2019.TRIAL REGISTRATION: ISRCTN registry 71907627 . Prospectively registered on 25 April 2013.

AB - BACKGROUND: For adults surviving stroke due to spontaneous (non-traumatic) intracerebral haemorrhage (ICH) who had taken an antithrombotic (i.e. anticoagulant or antiplatelet) drug for the prevention of vaso-occlusive disease before the ICH, it is unclear whether starting antiplatelet therapy modifies the risks of recurrent ICH, major haemorrhagic events, major occlusive vascular events, or a composite of all major vascular events compared to avoiding antiplatelet therapy.METHODS/DESIGN: The REstart or STop Antithrombotics Randomised Trial (RESTART) is an investigator-led, parallel group, open, assessor-blind, randomised trial comparing starting versus avoiding antiplatelet therapy for adults surviving antithrombotic-associated ICH. Recruitment began on 22 May 2013 and ended on 31 May 2018. Follow-up ended on 30 November 2018. This update to the protocol describes the statistical analysis plan (version 1.7, finalised on 25 January 2019). Database lock and un-blinding occurred on 29 January 2019, after which the un-masked trial statistician conducted the final analyses according to this statistical analysis plan.DISCUSSION: Final results of RESTART will be analysed and disseminated in May 2019.TRIAL REGISTRATION: ISRCTN registry 71907627 . Prospectively registered on 25 April 2013.

U2 - 10.1186/s13063-019-3270-2

DO - 10.1186/s13063-019-3270-2

M3 - Article

C2 - 30909946

SN - 1745-6215

VL - 20

SP - 183

JO - Trials

JF - Trials

IS - 1

ER -

The REstart or STop Antithrombotics Randomised Trial (RESTART) after stroke due to intracerebral haemorrhage: statistical analysis plan for a randomised controlled trial

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