ArticleEuropean journal of clinical pharmacology2017
The representativeness of direct oral anticoagulant clinical trials to hospitalized patients with atrial fibrillation.
Article in European journal of clinical pharmacology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers, 1 of them a synthesis that pooled it.
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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.
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Who cites it
10 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Association of Drug-Disease Interactions with Mortality or Readmission in Hospitalised Middle-Aged and Older Adults: A Systematic Review and Meta-Analysis.Drugs - real world outcomes · 2024Pooled it
- Article
- Impact of Direct Oral Anticoagulant Uptake on Hospitalizations for Stroke/Transient Ischemic Attack, Intracranial Hemorrhage, and Gastrointestinal Bleeding in Individuals With Atrial Fibrillation: A Population-Based Study.Fundamental & clinical pharmacology · 2025Article
- Real-World Outcomes of Patients With Non-Valvular Atrial Fibrillation on Anticoagulants Ineligible for Phase III Trials of Direct Oral Anticoagulants - A Retrospective Cohort Study.Circulation reports · 2025Article
- Observational
- Impact of patient selection in clinical trials: application of ROCKET AF and ARISTOTLE criteria in GARFIELD-AF.Open heart · 2024Article
- Comparison of Direct Oral Anticoagulant Use for the Treatment of Non-Valvular Atrial Fibrillation in Pivotal Clinical Trials vs. the Real-World Setting: A Population-Based Study from Southern Italy.Pharmaceuticals (Basel, Switzerland) · 2021Article
- The Number of Concomitant Drugs and the Safety of Direct Oral Anticoagulants in Routine Care Patients with Atrial Fibrillation.TH open : companion journal to thrombosis and haemostasis · 2020Article
- Trends in oral anticoagulant prescribing in individuals with type 2 diabetes mellitus: a population-based study in the UK.BMJ open · 2020Article
- Representation of people with comorbidity and multimorbidity in clinical trials of novel drug therapies: an individual-level participant data analysis.BMC medicine · 2019Article
Corrections and comments
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Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeTrials of the direct oral anticoagulants (DOACs) dabigatran, rivaroxaban and apixaban provide the basis for prescribing for the prevention of stroke and systemic embolism in atrial fibrillation (AF). The objective of this study was to assess the representativeness of the three pivotal DOAC randomized controlled trials of dabigatran, rivaroxaban and apixaban for unselected hospitalized patients with AF.
methodsA cross-sectional study was undertaken. All patients discharged with AF between 2012 and 2015 from a large public hospital network in Melbourne, Australia, were identified. Inclusion and exclusion criteria from the DOAC trials were applied. The proportions of hospitalized patients with AF who would have been eligible for the dabigatran (RE-LY), rivaroxaban (ROCKET-AF) and apixaban (ARISTOTLE) trials were estimated, as was pooled eligibility for all three trials. Characteristics of eligible and ineligible patients were compared.
resultsFor the 4734 patients, application of the inclusion and exclusion criteria resulted in 60.5, 52.6 and 35.8% eligibility for the trials of apixaban, dabigatran and rivaroxaban, respectively. Pooled eligibility across all three trials demonstrated that 33.4% of the patients would have been eligible for all three trials but 36.7% ineligible for any trial. Ineligible patients who met exclusion criteria were older and experienced more comorbidities.
conclusionsThe apixaban and dabigatran trials may be the most representative of hospitalized patients with AF. The DOAC trial results can readily be extrapolated to, and guide prescribing for, at least two thirds of patients discharged from a large metropolitan health service in Australia.
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