Key result
The RESTART trial statistical analysis plan outlines the methodology to evaluate whether starting versus avoiding antiplatelet therapy affects recurrent intracerebral hemorrhage, with no clinical results reported.
Why the study?
In adults surviving spontaneous ICH who previously took antithrombotics for vaso-occlusive disease prevention, it is unclear whether starting antiplatelet therapy modifies recurrent ICH or vascular event risks compared to avoiding it.
Does starting antiplatelet therapy modify the risk of recurrent symptomatic ICH in adults surviving antithrombotic-associated ICH compared to avoiding antiplatelet therapy?
RCT (n=720)
Open, assessor-blind
1:1 using a minimisation algorithm
Yes
Does starting antiplatelet therapy modify the risk of recurrent symptomatic ICH in adults surviving antithrombotic-associated ICH compared to avoiding antiplatelet therapy?
This statistical analysis plan outlines the methodology for the RESTART trial, which investigates the safety and efficacy of resuming antiplatelet therapy in survivors of antithrombotic-associated intracerebral hemorrhage.
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.
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Salman et al. (2019) conducted an RCT in Spontaneous intracerebral haemorrhage (ICH) (n=720). Antiplatelet therapy vs. Avoiding antiplatelet therapy was evaluated on Fatal or non-fatal radiographically or pathologically proven recurrent symptomatic ICH. The RESTART trial statistical analysis plan outlines the methodology to evaluate whether starting versus avoiding antiplatelet therapy affects recurrent intracerebral hemorrhage, with no clinical results reported.
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