Evidence map›Paper›PMID 25919061›Full record

Trial reportEuropean journal of heart failure2015

Rationale and design of a randomized, double-blind, event-driven, multicentre study comparing the efficacy and safety of oral rivaroxaban with placebo for reducing the risk of death, myocardial infarction or stroke in subjects with heart failure and significant coronary artery disease following an exacerbation of heart failure: the COMMANDER HF trial.

Faiez Zannad, Barry Greenberg, John G F Cleland, Mihai Gheorghiade, Dirk J van Veldhuisen, Mandeep R Mehra, Stefan D Anker, William M Byra, Min Fu, Roger M Mills

Open access · hybridAbstract readComparative StudyMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in European journal of heart failure, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 22 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
22citing papers in PubMed, 2 pooled it
11.5field-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.

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

22 citing papers in PubMed, 2 syntheses or guidelines pooled it, 78 citations in OpenAlex.

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  16. Sustained atrial fibrillation increases the risk of anticoagulation-related bleeding in heart failure.Clinical research in cardiology : official journal of the German Cardiac Society · 2018
    Article
  17. Heart Failure and Stroke.Current heart failure reports · 2018
    Review
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

10 authors at 8 institutions in 5 countries.

Faiez ZannadInserm Centre d'Investigation Clinique CIC 1433, UMR 1116, CHU de Nancy, Institut Lorrain du Coeur et des Vaisseaux, Université de Lorraine, Nancy, France.
Barry GreenbergDepartment of Medicine, Cardiology Division, University of California, San Diego, La Jolla, CA, USA.
John G F ClelandNational Heart and Lung Institute, Royal Brompton and Harefield Hospitals, Imperial College, London, England.
Mihai GheorghiadeCenter for Cardiovascular Innovation, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.
Dirk J van VeldhuisenDepartment of Cardiology, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands.
Mandeep R MehraBrigham and Women's Hospital Heart and Vascular Center, and Harvard Medical School, Boston, MA, USA.
Stefan D AnkerDivision of Innovative Clinical Trials, Department of Cardiology, University Medical Centre Göttingen (UMG), Göttingen, Germany.
William M ByraJanssen Research & Development, LLC, 920 US 202, Raritan, NJ, USA.
Min FuJanssen Research & Development, LLC, 920 US 202, Raritan, NJ, USA.
Roger M MillsJanssen Research & Development, LLC, 920 US 202, Raritan, NJ, USA.
Janssen (United States) · USHarvard University · USImperial College London · GBInserm · FRNorthwestern University · USUniversity Medical Center Groningen · NLUniversity of California San Diego · USUniversity of Göttingen · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsThrombin is a critical element of crosstalk between pathways contributing to worsening of established heart failure (HF). The aim of this study is to explore the efficacy and safety of rivaroxaban 2.5 mg bid compared with placebo (with standard care) after an exacerbation of HF in patients with reduced ejection fraction (HF-rEF) and documented coronary artery disease.

methodsThis is an international prospective, multicentre, randomized, double-blind, placebo-controlled, event-driven study of approximately 5000 patients for a targeted 984 events. Patients must have a recent symptomatic exacerbation of HF, increased plasma concentrations of natriuretic peptides (B-type natriuretic peptide ≥200 pg/mL or N-terminal pro-B-type natriuretic peptide ≥800 pg/mL), with left ventricular ejection fraction ≤40% and coronary artery disease. Patients requiring anticoagulation for atrial fibrillation or other conditions will be excluded. After an index event (overnight hospitalization, emergency department or observation unit admission, or unscheduled outpatient parenteral treatment for worsening HF), patients will be randomized 1:1 to rivaroxaban or placebo (with standard of care). The primary efficacy outcome event is a composite of all-cause mortality, myocardial infarction or stroke. The principal safety outcome events are the composite of fatal bleeding or bleeding into a critical space with potential permanent disability, bleeding events requiring hospitalization and major bleeding events according to International Society on Thrombosis and Haemostasis bleeding criteria.

conclusionCOMMANDER HF is the first prospective study of a target-specific oral antithrombotic agent in HF. It will provide important information regarding rivaroxaban use following an HF event in an HF-rEF patient population with coronary artery disease.

Indexed as

Research DesignAdministration, OralCoronary Artery DiseaseDouble-Blind MethodFactor Xa InhibitorsHeart FailureHumansMyocardial InfarctionProspective StudiesRisk FactorsRivaroxabanStrokeSurvival RateFactor Xa InhibitorsRivaroxabanantithromboticcoronary artery diseaseheart failurerivaroxabanthrombin

Identifiers

PMID25919061
PMCPMC5029775
OpenAlexW1604096140

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.