Evidence map›Paper›PMID 33392636›Full record

Trial reportJournal of neurology2021

Early apixaban therapy after ischemic stroke in patients with atrial fibrillation.

Anas Alrohimi, Brian Buck, Glen Jickling, Ashfaq Shuaib, Sibi Thirunavukkarasu, Ken S Butcher

Registry-linked trialAbstract readClinical Trial
PubMed Publisher
In one paragraph

Trial report in Journal of neurology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04435418 (Eliquis Acute Stroke Safety Evaluation), which is not on this map. Cited by 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 1 pooled it
–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.

NCT04435418 completednot on this map

Eliquis Acute Stroke Safety Evaluation

Typeobservational_patient_registrySponsorUniversity of AlbertaRan2017 to 2019Enrolled100ConditionsIschemic Stroke, Transient Ischemic Attack, Atrial FibrillationArmsApixaban
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Review
  3. Article
  4. Article
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

6 authors.

Anas AlrohimiUniversity of Alberta, Medicine, Edmonton, Canada.ORCID http://orcid.org/0000-0001-7601-6920
Brian BuckUniversity of Alberta, Medicine, Edmonton, Canada.
Glen JicklingUniversity of Alberta, Medicine, Edmonton, Canada.
Ashfaq ShuaibUniversity of Alberta, Medicine, Edmonton, Canada.
Sibi ThirunavukkarasuUniversity of Alberta, Medicine, Edmonton, Canada.
Ken S ButcherUniversity of Alberta, Medicine, Edmonton, Canada. ken.butcher@unsw.edu.au.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe optimal timing of anticoagulation after stroke in patients with atrial fibrillation (AF) is unknown. We aimed to objectively assess the rate of radiological hemorrhagic transformation (HT) associated with early anticoagulation. PATIENTS AND

methodsA prospective, open label study (NCT04435418) of patients with AF treated with apixaban within 14 days of ischemic stroke/TIA onset was conducted. Baseline and follow-up CT scans were assessed for HT and graded using European Cooperative Acute Stroke Study (ECASS) criteria. The primary endpoint was symptomatic HT. Incident HT rates were assessed as Objective Performance Criteria.

resultsOne-hundred AF stroke patients, with a mean age of 79 ± 11 years were enrolled. Median infarct volume was 4 (0.5-10.75) ml. Median time from index event onset to apixaban initiation was 2 (1-6) days, and median baseline NIHSS was 4 (1-9). Asymptomatic HT on baseline imaging was present in 15 patients. Infarct volume (OR = 1.1, [1.02-1.12], p < 0.0001) and NIHSS (OR = 1.11, [1.03-1.20], p = 0.007) were both associated with baseline HT. No patients developed symptomatic HT or systemic hemorrhage. Incident asymptomatic HT was seen on follow-up CT scan in 3 patients. Patients with incident HT were functionally independent (mRS = 0-2) at 90 days. Recurrent ischemic events occurred within 90 days in 13 patients, 4 of which were associated with severe disability (mRS 3-5) and 4 with death. DISCUSSION: Early apixaban treatment did not precipitate symptomatic HT after stroke. All HT was asymptomatic identified on imaging. Recurrent ischemic events were common and clinically symptomatic.

conclusionsSymptomatic HT rates are likely to be low in randomized trials of DOAC initiation post-stroke. Recurrent ischemic stroke may be the major clinical outcome. These data may be used as expected event rates when calculating sample size requirements for future safety/efficacy trials of early versus late DOAC initiation after AF-related stroke.

Indexed as

Atrial FibrillationBrain IschemiaIschemic StrokeStrokeAgedAged, 80 and overAnticoagulantsHumansProspective StudiesPyrazolesPyridonesTreatment OutcomeAnticoagulantsapixabanPyrazolesPyridonesApixabanAtrial fibrillationCardioembolic strokeHemorrhagic transformationIntracerebral hemorrhageIschemic stroke

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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.