Evidence map›Paper›PMID 36889611›Full record

Trial reportJournal of the American College of Cardiology2023

Randomized Trial of Anticoagulation Strategies for Noncritically Ill Patients Hospitalized With COVID-19.

Gregg W Stone, Michael E Farkouh, Anuradha Lala, Elizabeth Tinuoye, Ovidiu Dressler, Pedro R Moreno, Igor F Palacios, Shaun G Goodman, Rodrigo B Esper, Alexandre Abizaid and 22 more

Registry-linked trialAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Journal of the American College of Cardiology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04512079 (FREEDOM COVID Anticoagulation Strategy Randomized Trial), which is not on this map. Cited by 32 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
32citing papers in PubMed, 3 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.

NCT04512079 phase4completednot on this map

FREEDOM COVID Anticoagulation Strategy Randomized Trial

TypeinterventionalSponsorValentin FusterRan2020 to 2022Enrolled3,460ConditionsCOVID-19, SARS-CoV-2ArmsEnoxaparin, Apixaban
3 · Its place in the literature

Who cites it

32 citing papers in PubMed, 3 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Guideline
  4. Trial
  5. Trial
  6. Trial
  7. Acute SARS-CoV-2 infection.Nature reviews. Disease primers · 2025
    Review
  8. Review
  9. Article
  10. Article
  11. Article
  12. Review
  13. COVID-19: a vascular nightmare unfolding.Frontiers in immunology · 2025
    Review
  14. Article
  15. Article
  16. Article
  17. Article
  18. Article
  19. Review
  20. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

32 authors.

Gregg W StoneThe Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York, USA.
Michael E FarkouhPeter Munk Cardiac Centre, University of Toronto, Toronto, Ontario, Canada.
Anuradha LalaThe Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York, USA.
Elizabeth TinuoyeThe Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York, USA.
Ovidiu DresslerCardiovascular Research Foundation, New York, New York, USA.
Pedro R MorenoThe Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York, USA.
Igor F PalaciosMassachusetts General Hospital, Boston, Massachusetts, USA.
Shaun G GoodmanSt Michael's Hospital, Unity Heath, University of Toronto, Toronto, Ontario, Canada; Canadian VIGOUR Centre, University of Alberta, Edmonton, Alberta, Canada.
Rodrigo B EsperPrevent Senior Institute, São Paulo, São Paulo, Brazil.
Alexandre AbizaidHeart Institute (InCor), University of São Paulo Medical School, São Paulo, Brazil.
Deepak VaradeBAJ RR Hospital, Mumbai, India.
Juan F BetancurClínica Medellín QuirónSalud, Medellín, Colombia.
Alejandro RicaldeCITIC, Mexico City, Mexico.
Gerardo PayroInstituto Nacional de Ciencias Medicas y Nutrición Salvador Zubiran, Mexico City, Mexico.
José María CastellanoCentro Integral de Enfermedades Cardiovasculares (CIEC), Hospital Universitario Monterpincipe, Grupo HM Hospitales, Madrid, Spain.
Ivan F N HungThe University of Hong Kong, Hong Kong.
Girish N NadkarniThe Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York, USA; The Charles Bronfman Institute of Personalized Medicine, Icahn School of Medicine at Mount Sinai, New York, New York, USA; Division of Data Driven and Digital Medicine, Icahn School of Medicine at Mount Sinai, New York, New York, USA.
Gennaro GiustinoThe Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York, USA.
Lucas C GodoyPeter Munk Cardiac Centre, University of Toronto, Toronto, Ontario, Canada.
Jason FeinmanThe Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York, USA.
Anton CamajThe Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York, USA.
Solomon W BienstockThe Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York, USA.
Remo H M FurtadoBrazilian Clinical Research Institute, São Paulo, Brazil.
Carlos GranadaCogenTech Medical and Digital Innovation, Mahwah, New Jersey, USA.
Jessica BustamanteThe Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York, USA.
Carlos PeyraThe Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York, USA.
Johanna ContrerasThe Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York, USA.
Ruth OwenLondon School of Hygiene and Tropical Medicine, London, United Kingdom.
Deepak L BhattThe Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York, USA.
Stuart J PocockLondon School of Hygiene and Tropical Medicine, London, United Kingdom.
Valentin FusterThe Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York, USA; Centro Nacional de Investigaciones Cardiovasculares (CNIC), Madrid, Spain. Electronic address: valentin.fuster@mountsinai.org.
FREEDOM COVID Anticoagulation Strategy Randomized Trial Investigators

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPrior studies of therapeutic-dose anticoagulation in patients with COVID-19 have reported conflicting results.

objectivesWe sought to determine the safety and effectiveness of therapeutic-dose anticoagulation in noncritically ill patients with COVID-19.

methodsPatients hospitalized with COVID-19 not requiring intensive care unit treatment were randomized to prophylactic-dose enoxaparin, therapeutic-dose enoxaparin, or therapeutic-dose apixaban. The primary outcome was the 30-day composite of all-cause mortality, requirement for intensive care unit-level of care, systemic thromboembolism, or ischemic stroke assessed in the combined therapeutic-dose groups compared with the prophylactic-dose group.

resultsBetween August 26, 2020, and September 19, 2022, 3,398 noncritically ill patients hospitalized with COVID-19 were randomized to prophylactic-dose enoxaparin (n = 1,141), therapeutic-dose enoxaparin (n = 1,136), or therapeutic-dose apixaban (n = 1,121) at 76 centers in 10 countries. The 30-day primary outcome occurred in 13.2% of patients in the prophylactic-dose group and 11.3% of patients in the combined therapeutic-dose groups (HR: 0.85; 95% CI: 0.69-1.04; P = 0.11). All-cause mortality occurred in 7.0% of patients treated with prophylactic-dose enoxaparin and 4.9% of patients treated with therapeutic-dose anticoagulation (HR: 0.70; 95% CI: 0.52-0.93; P = 0.01), and intubation was required in 8.4% vs 6.4% of patients, respectively (HR: 0.75; 95% CI: 0.58-0.98; P = 0.03). Results were similar in the 2 therapeutic-dose groups, and major bleeding in all 3 groups was infrequent.

conclusionsAmong noncritically ill patients hospitalized with COVID-19, the 30-day primary composite outcome was not significantly reduced with therapeutic-dose anticoagulation compared with prophylactic-dose anticoagulation. However, fewer patients who were treated with therapeutic-dose anticoagulation required intubation and fewer died (FREEDOM COVID [FREEDOM COVID Anticoagulation Strategy]; NCT04512079).

Indexed as

COVID-19ThromboembolismAnticoagulantsBlood CoagulationEnoxaparinHumansAnticoagulantsEnoxaparinapixabancoronavirus disease 2019enoxaparinprognosissevere acute respiratory syndrome coronavirus 2

Identifiers

PMID36889611
PMCPMC9987252

What OpenQuestion holds

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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.