Evidence map›Paper›PMID 33577800›Full record

ArticleAmerican heart journal2021

Rationale and design for the study of rivaroxaban to reduce thrombotic events, hospitalization and death in outpatients with COVID-19: The PREVENT-HD study.

Warren H Capell, Elliot S Barnathan, Gregory Piazza, Alex C Spyropoulos, Judith Hsia, Scott Bull, Concetta Lipardi, Chiara Sugarmann, Eunyoung Suh, Jaya Prakash Rao and 2 more

Open access · greenAbstract readClinical Trial Protocol
In one paragraph

Article in American heart journal, 2021. 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
2.7field-weighted citation impact, top 8% 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, 44 citations in OpenAlex.

  1. Pooled it
  2. Prophylactic anticoagulants for non-hospitalised people with COVID-19.The Cochrane database of systematic reviews · 2023
    Pooled it
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  7. Thromboprophylaxis in Pregnant Women with COVID-19: An Unsolved Issue.International journal of environmental research and public health · 2023
    Review
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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

12 authors at 5 institutions in 1 country.

Warren H CapellCPC Clinical Research, Aurora, CO; Division of Endocrinology, Diabetes, and Metabolism, Department of Medicine, University of Colorado Anschutz Medical Campus, Aurora, CO. Electronic address: warren.capell@cuanschutz.edu.
Elliot S BarnathanJanssen Research and Development LLC, Raritan, NJ.
Gregory PiazzaDivision of Cardiovascular Medicine, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA.
Alex C SpyropoulosDonald and Barbara Zucker School of Medicine at Hofstra/Northwell, Huntington, NY; Institute for Health Innovation and Outcomes Research, Feinstein Institutes for Medical Research, Manhasset, NY; Department of Medicine, Northwell Health at Lenox Hill Hospital, New York, NY.
Judith HsiaCPC Clinical Research, Aurora, CO; Division of Cardiology, Department of Medicine, University of Colorado Anschutz Medical Campus, Aurora, CO.
Scott BullJanssen Research and Development LLC, Raritan, NJ.
Concetta LipardiJanssen Research and Development LLC, Raritan, NJ.
Chiara SugarmannJanssen Research and Development LLC, Raritan, NJ.
Eunyoung SuhJanssen Research and Development LLC, Raritan, NJ.
Jaya Prakash RaoREDCap Cloud, Encinitas, CA.
William R HiattCPC Clinical Research, Aurora, CO; Division of Cardiology, Department of Medicine, University of Colorado Anschutz Medical Campus, Aurora, CO.
Marc P BonacaCPC Clinical Research, Aurora, CO; Division of Cardiology, Department of Medicine, University of Colorado Anschutz Medical Campus, Aurora, CO.
Janssen (United States) · USThe Medical Center of Aurora · USBrigham and Women's Hospital · USMeridian Clinical Research · USNorthwell Health · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundCOVID-19 is associated with both venous and arterial thrombotic complications. While prophylactic anticoagulation is now widely recommended for hospitalized patients with COVID-19, the effectiveness and safety of thromboprophylaxis in outpatients with COVID-19 has not been established. STUDY

designPREVENT-HD is a double-blind, placebo-controlled, pragmatic, event-driven phase 3 trial to evaluate the efficacy and safety of rivaroxaban in symptomatic outpatients with laboratory-confirmed COVID-19 at risk for thrombotic events, hospitalization, and death. Several challenges posed by the pandemic have necessitated innovative approaches to clinical trial design, start-up, and conduct. Participants are randomized in a 1:1 ratio, stratified by time from COVID-19 confirmation, to either rivaroxaban 10 mg once daily or placebo for 35 days. The primary efficacy end point is a composite of symptomatic venous thromboembolism, myocardial infarction, ischemic stroke, acute limb ischemia, non-central nervous system systemic embolization, all-cause hospitalization, and all-cause mortality. The primary safety end point is fatal and critical site bleeding according to the International Society on Thrombosis and Haemostasis definition. Enrollment began in August 2020 and is expected to enroll approximately 4,000 participants to yield the required number of end point events.

conclusionsPREVENT-HD is a pragmatic trial evaluating the efficacy and safety of the direct oral anticoagulant rivaroxaban in the outpatient setting to reduce major venous and arterial thrombotic events, hospitalization, and mortality associated with COVID-19.

Indexed as

COVID-19Factor Xa InhibitorsHospitalizationOutpatientsRivaroxabanThrombosisAdultCause of DeathClinical Trials, Phase III as TopicDouble-Blind MethodExtremitiesFemaleHemorrhageHospital MortalityHumansIschemiaFactor Xa InhibitorsPlacebosRivaroxaban

Identifiers

PMID33577800
PMCPMC7871775
OpenAlexW3126183465

What OpenQuestion holds

Textmetadata
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.