Evidence map›Paper›PMID 39966982›Full record

ArticleTrials2025

Optimal timing of anticoagulation after acute ischaemic stroke with atrial fibrillation (OPTIMAS): statistical analysis plan for a randomised controlled trial.

Norin Ahmed, Hakim-Moulay Dehbi, Nick Freemantle, Jonathan Best, Philip S Nash, James K Ruffle, David Doig, David J Werring

Registry-linked trialAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03759938 (OPtimal TIMing of Anticoagulation After Acute Ischaemic Stroke), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–field-weighted citation impact
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.

NCT03759938 naunknown statusnot on this map

OPtimal TIMing of Anticoagulation After Acute Ischaemic Stroke: a Randomised Controlled Trial

TypeinterventionalSponsorUniversity College, LondonRan2019 to 2024Enrolled3,648ConditionsStroke, Acute, Atrial FibrillationArmsDirect oral anticoagulant (DOAC)
3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Trial
  2. Trial
  3. 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

8 authors.

Norin AhmedComprehensive Clinical Trials Unit, Institute of Clinical Trials and Methodology, University College London, London, UK. n.mumtaz@ucl.ac.uk.ORCID http://orcid.org/0000-0001-8798-5217
Hakim-Moulay DehbiComprehensive Clinical Trials Unit, Institute of Clinical Trials and Methodology, University College London, London, UK.
Nick FreemantleComprehensive Clinical Trials Unit, Institute of Clinical Trials and Methodology, University College London, London, UK.
Jonathan BestStroke Research Centre, Department of Brain Repair and Rehabilitation, UCL Queen Square Institute of Neurology, London, UK.
Philip S NashStroke Research Centre, Department of Brain Repair and Rehabilitation, UCL Queen Square Institute of Neurology, London, UK.
James K RuffleUCL Queen Square Institute of Neurology, University College London, London, UK.
David DoigDepartment of Neuroradiology, National Hospital for Neurology and Neurosurgery, University College London Hospitals NHS Trust, London, UK.
David J WerringStroke Research Centre, Department of Brain Repair and Rehabilitation, UCL Queen Square Institute of Neurology, London, UK.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAtrial fibrillation causes one-fifth of ischaemic strokes, with a high risk of early recurrence. Although long-term anticoagulation is highly effective for stroke prevention in atrial fibrillation, initiation after stroke can be delayed by concerns over intracranial haemorrhage risk. Direct oral anticoagulants offer a significantly lower risk of intracranial haemorrhage than other anticoagulants, potentially allowing earlier anticoagulation and prevention of ischaemic stroke recurrence, but the safety and efficacy of this approach has not been established. This article describes the statistical analysis plan for the OPTIMAS trial as an update to the published protocol. It was written prior to the end of patient follow-up, before database lock and thus while the outcome of the trial is still unknown.

aimThe optimal timing of anticoagulation after acute ischaemic stroke with atrial fibrillation (OPTIMAS) trial will investigate whether early treatment with a direct oral anticoagulant within 4 days of stroke onset is as effective as, or better than, delayed initiation at 7 to 14 days from onset. METHODS AND

designOPTIMAS is a multicentre randomised controlled trial with blinded outcome adjudication. Participants with acute ischaemic stroke and atrial fibrillation eligible for anticoagulation with a direct oral anticoagulant are randomised 1:1 to early or delayed initiation. Here, we describe in detail the statistical aspects of OPTIMAS, including outcome measures, sample size calculation, general analysis principles, descriptive statistics, statistical models, and planned subgroup analyses. STUDY OUTCOMES: The primary outcome is a composite of recurrent stroke (ischaemic stroke or symptomatic intracranial haemorrhage) and systemic arterial embolism within 90 days. Secondary outcomes include each individual component of the composite outcome, major bleeding, functional status assessed by the modified Rankin Scale, ongoing anticoagulation, quality of life, health and social care resource use, and length of hospital stay. DISCUSSION: OPTIMAS aims to provide high-quality evidence on the safety and efficacy of early direct oral anticoagulant initiation after atrial fibrillation-associated acute ischaemic stroke. TRIAL REGISTRATIONS: ISRCTN: 17,896,007; ClinicalTrials.gov: NCT03759938. Registered on November 30 2018.

Indexed as

AnticoagulantsAtrial FibrillationIschemic StrokeTime-to-TreatmentAdministration, OralData Interpretation, StatisticalDrug Administration ScheduleHumansIntracranial HemorrhagesMulticenter Studies as TopicRandomized Controlled Trials as TopicRecurrenceRisk FactorsSecondary PreventionTime FactorsTreatment OutcomeAnticoagulantsAcute ischaemic strokeAnticoagulationAtrial fibrillationDOAC (direct oral anticoagulants)Statistical analysis planTiming

Identifiers

PMID39966982
PMCPMC11837694

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Registered trials

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.