Evidence map›Paper›PMID 30909946›Full record

ArticleTrials2019

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

Open access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
1.1field-weighted citation impact, top 23% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 10 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Trial
  4. Article
  5. Review
  6. Role of Cerebral Microbleeds for Intracerebral Haemorrhage and Dementia.Current neurology and neuroscience reports · 2019
    Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors at 4 institutions in 1 country.

Rustam Al-Shahi SalmanCentre for Clinical Brain Sciences, University of Edinburgh, Chancellor's Building, 49 Little France Crescent, Edinburgh, EH16 4SB, UK. rustam.al-shahi@ed.ac.uk.ORCID http://orcid.org/0000-0002-2108-9222
Gordon D MurrayUsher Institute of Population Health Sciences and Informatics, University of Edinburgh, Edinburgh, UK.
Martin S DennisCentre for Clinical Brain Sciences, University of Edinburgh, Chancellor's Building, 49 Little France Crescent, Edinburgh, EH16 4SB, UK.
David E NewbyCentre for Cardiovascular Science, University of Edinburgh, Edinburgh, UK.
Peter A G SandercockCentre for Clinical Brain Sciences, University of Edinburgh, Chancellor's Building, 49 Little France Crescent, Edinburgh, EH16 4SB, UK.
Nikola SpriggFaculty of Medicine & Health Sciences, University of Nottingham, Nottingham, UK.
Cathie L M SudlowCentre for Clinical Brain Sciences, University of Edinburgh, Chancellor's Building, 49 Little France Crescent, Edinburgh, EH16 4SB, UK.
David J WerringInstitute of Neurology, University College London, London, UK.
Philip M WhiteInstitute of Neuroscience and Newcastle University Institute for Ageing, Newcastle-upon-Tyne, UK.
William N WhiteleyCentre for Clinical Brain Sciences, University of Edinburgh, Chancellor's Building, 49 Little France Crescent, Edinburgh, EH16 4SB, UK.
University of Edinburgh · GBNewcastle Hospitals - Campus for Ageing and Vitality · GBUniversity College London · GBUniversity of Nottingham · GB

Funding

British Heart Foundation CH/09/002/26360British Heart Foundation FS/13/72/30531British Heart Foundation SP/12/2/29422Chief Scientist Office SCAF/17/01
6 · The paper itself

Abstract

backgroundFor 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/

designThe 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 registrationISRCTN registry 71907627 . Prospectively registered on 25 April 2013.

Indexed as

AnticoagulantsCerebral HemorrhageData Interpretation, StatisticalDrug Administration ScheduleFibrinolytic AgentsHumansPlatelet Aggregation InhibitorsRandomized Controlled Trials as TopicRecurrenceRisk AssessmentRisk FactorsSecondary PreventionStrokeTime FactorsTreatment OutcomeAnticoagulantsFibrinolytic AgentsPlatelet Aggregation Inhibitorsantiplatelet therapyintracerebral haemorrhagerandomised controlled trialSecondary preventionstatistical analysis planstroke

Identifiers

PMID30909946
PMCPMC6434884
OpenAlexW2941831225

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.