Evidence map›Paper›PMID 35385695›Full record

Trial reportLancet (London, England)2022

Safety of the oral factor XIa inhibitor asundexian compared with apixaban in patients with atrial fibrillation (PACIFIC-AF): a multicentre, randomised, double-blind, double-dummy, dose-finding phase 2 study.

Jonathan P Piccini, Valeria Caso, Stuart J Connolly, Keith A A Fox, Jonas Oldgren, W Schuyler Jones, Diana A Gorog, Václav Durdil, Thomas Viethen, Christoph Neumann and 3 more

Registry-linked trialOpen access · bronzeAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Lancet (London, England), 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT07320768 (The Efficacy and Safety of Renal Denervation Combined With Pulsed Field Ablation in Preventing Recurrence of Atrial Arrhythmia in Patients With Persistent Atrial Fibrillation), which is not on this map. Cited by 145 papers, 11 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
145citing papers in PubMed, 11 pooled it
43.9field-weighted citation impact, top 1% 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.

NCT07320768 naactive not recruitingnot on this mapstarted 2026, after this paper: background citation

The Efficacy and Safety of Renal Denervation Combined With Pulsed Field Ablation in Preventing Recurrence of Atrial Arrhythmia in Patients With Persistent Atrial Fibrillation: An OFF-MED Trial

TypeinterventionalSponsorShanghai Chest HospitalRan2026 to 2027Enrolled86ConditionsPersistent Atrial FibrillationArmsrenal denervation, Pulsed-Field Ablation (PFA)
3 · Its place in the literature

Who cites it

145 citing papers in PubMed, 11 syntheses or guidelines pooled it, 300 citations in OpenAlex.

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  7. Déjà vu all over again: a recurrent flaw in anticoagulant study design.Journal of thrombosis and haemostasis : JTH · 2025
    Pooled it
  8. Optimal management of cardiac surgery patients using direct oral anticoagulants: recommendations for clinical practice.European journal of cardio-thoracic surgery : official journal of the European Association for Cardio-thoracic Surgery · 2023
    Pooled it
  9. Guideline
  10. A Systematic Review of Factor XI/XIa Inhibitors Versus Direct Oral Anticoagulants in Patients with Atrial Fibrillation.Clinical and applied thrombosis/hemostasis : official journal of the International Academy of Clinical and Applied Thrombosis/Hemostasis
    Pooled it
  11. Evaluating the Safety and Efficacy of Asundexian in Cardiovascular Disease: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.Clinical and applied thrombosis/hemostasis : official journal of the International Academy of Clinical and Applied Thrombosis/Hemostasis
    Pooled it
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85 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

13 authors at 11 institutions in 8 countries.

Jonathan P PicciniDuke Clinical Research Institute, Duke University School of Medicine, Durham, NC, USA; Duke University Medical Center, Durham, NC, USA. Electronic address: jonathan.piccini@duke.edu.
Valeria CasoUniversity of Perugia Stroke Unit, Perugia, Italy.
Stuart J ConnollyPopulation Health Research Institute, McMaster University, Hamilton, ON, Canada; Hamilton Health Services, Hamilton, ON, Canada.
Keith A A FoxDivision of Medical and Radiological Sciences, University of Edinburgh, Edinburgh, UK.
Jonas OldgrenUppsala Clinical Research Center, Uppsala University, Uppsala, Sweden.
W Schuyler JonesDuke Clinical Research Institute, Duke University School of Medicine, Durham, NC, USA; Duke University Medical Center, Durham, NC, USA.
Diana A GorogNational Heart and Lung Institute, Imperial College London, London, UK; University of Hertfordshire, Hatfield, UK.
Václav DurdilUniversity Hospital Motol, Prague, Czech Republic.
Thomas ViethenBayer, Wuppertal, Germany.
Christoph NeumannBayer, Wuppertal, Germany.
Hardi MundlBayer, Wuppertal, Germany.
Manesh R PatelDuke Clinical Research Institute, Duke University School of Medicine, Durham, NC, USA; Duke University Medical Center, Durham, NC, USA.
PACIFIC-AF Investigators
Bayer (Germany) · DEDuke University · USImperial College London · GBUniversity Hospital in Motol · CZClinical Research Institute · USDuke Medical Center · USHamilton Health Sciences · CAUnité de recherche sur les maladies cardiovasculaires et métaboliques · FRUniversity of Edinburgh · GBUniversity of Perugia · ITUppsala University · SE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundDirect-acting oral anticoagulant use for stroke prevention in atrial fibrillation is limited by bleeding concerns. Asundexian, a novel, oral small molecule activated coagulation factor XIa (FXIa) inhibitor, might reduce thrombosis with minimal effect on haemostasis. We aimed to determine the optimal dose of asundexian and to compare the incidence of bleeding with that of apixaban in patients with atrial fibrillation.

methodsIn this randomised, double-blind, phase 2 dose-finding study, we compared asundexian 20 mg or 50 mg once daily with apixaban 5 mg twice daily in patients aged 45 years or older with atrial fibrillation, a CHA

findingsBetween Jan 30, 2020, and June 21, 2021, 862 patients were enrolled. 755 patients were randomly assigned to treatment. Two patients (assigned to asundexian 20 mg) never took any study medication, resulting in 753 patients being included in the analysis (249 received asundexian 20 mg, 254 received asundexian 50 g, and 250 received apixaban). The mean age of participants was 73·7 years (SD 8·3), 309 (41%) were women, 216 (29%) had chronic kidney disease, and mean CHA

interpretationThe FXIa inhibitor asundexian at doses of 20 mg and 50 mg once daily resulted in lower rates of bleeding compared with standard dosing of apixaban, with near-complete in-vivo FXIa inhibition, in patients with atrial fibrillation.

fundingBayer.

Indexed as

AnticoagulantsAtrial FibrillationFactor Xa InhibitorsAgedDouble-Blind MethodFemaleHemorrhageHumansMalePyrazolesPyridonesTreatment OutcomeAnticoagulantsapixabanFactor Xa InhibitorsPyrazolesPyridones

Identifiers

PMID35385695
OpenAlexW4223439574

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.