Randomized Clinical Trial to Evaluate a Routine Full Anticoagulation Strategy in Patients with Coronavirus Infection (SARS-CoV2) Admitted to Hospital: Rationale and Design of the ACTION (AntiCoagulaTlon cOroNavirus)-Coalition IV Trial.
Abstract
<h4>Background</h4>Observational studies have suggested a higher risk of thrombotic
events in patients with coronavirus disease 2019 (COVID-19). Moreover, elevated D-dimer
levels have been identified as an important prognostic marker in COVID-19 directly
associated with disease severity and progression. Prophylactic anticoagulation for
hospitalized COVID-19 patients might not be enough to prevent thrombotic events; therefore,
therapeutic anticoagulation regimens deserve clinical investigation.<h4>Design</h4>ACTION
is an academic-led, pragmatic, multicenter, open-label, randomized, phase IV clinical
trial that aims to enroll around 600 patients at 40 sites participating in the Coalition
COVID-19 Brazil initiative. Eligible patients with a confirmed diagnosis of COVID-19
with symptoms up to 14 days and elevated D-dimer levels will be randomized to a strategy
of full-dose anticoagulation for 30 days with rivaroxaban 20 mg once daily (or full-dose
heparin if oral administration is not feasible) versus standard of care with any approved
venous thromboembolism (VTE) prophylaxis regimen during hospitalization. A confirmation
of COVID-19 was mandatory for study entry, based on specific tests used in clinical
practice (RT-PCR, antigen test, IgM test) collected before randomization, regardless
of in the outpatient setting or not. Randomization will be stratified by clinical
stability at presentation. The primary outcome is a hierarchical analysis of mortality,
length of hospital stay, or duration of oxygen therapy at the end of 30 days. Secondary
outcomes include the World Health Organization's 8-point ordinal scale at 30 days
and the following individual efficacy outcomes: incidence of VTE, acute myocardial
infarction, stroke, systemic embolism, major adverse limb events, duration of oxygen
therapy, disease progression, and biomarkers. The primary safety outcomes are major
or clinically relevant non-major bleeding according to the International Society on
Thrombosis and Haemostasis criteria.<h4>Summary</h4>The ACTION trial will evaluate
whether in-hospital therapeutic anticoagulation with rivaroxaban for stable patients,
or enoxaparin for unstable patients, followed by rivaroxaban through 30 days compared
with standard prophylactic anticoagulation improves clinical outcomes in hospitalized
patients with COVID-19 and elevated D-dimer levels. CLINICALTRIALS.GOV: : NCT04394377.
Type
Journal articlePermalink
https://hdl.handle.net/10161/22859Published Version (Please cite this version)
10.1016/j.ahj.2021.04.005Publication Info
Lopes, Renato D; de Barros E Silva, Pedro Gabriel Melo; Furtado, Remo HM; Macedo,
Ariane Vieira Scarlatelli; Ramacciotti, Eduardo; Damini, Lucas Petri; ... Coalition
COVID-19 Brazil IV Investigators (2021). Randomized Clinical Trial to Evaluate a Routine Full Anticoagulation Strategy in Patients
with Coronavirus Infection (SARS-CoV2) Admitted to Hospital: Rationale and Design
of the ACTION (AntiCoagulaTlon cOroNavirus)-Coalition IV Trial. American heart journal. 10.1016/j.ahj.2021.04.005. Retrieved from https://hdl.handle.net/10161/22859.This is constructed from limited available data and may be imprecise. To cite this
article, please review & use the official citation provided by the journal.
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Show full item recordScholars@Duke
John Hunter Peel Alexander
Professor of Medicine
John H. Alexander, MD, MHS is a cardiologist and Professor of Medicine in the Department
of Medicine, Division of Cardiology at Duke University School of Medicine, as well
as the Vice Chief, Clinical Research in the Division of Cardiology. He is the Director
of Cardiovascular Research at the Duke Clinical Research Institute where he oversees
a large group of clinical research faculty and a broad portfolio of cardiovascular
clinical trials and observational clinical research programs. He is a
Renato Delascio Lopes
Professor of Medicine
Atrial Fibrillation Antithrombotic Therapy in patients with Acute Coronary Syndromes
Elderly patients with Heart Disease Biomarkers in Acute Coronary Syndromes and Atrial
Fibrillation Thrombosis and Anticoagulation and novel antithrombotic agents Metabolomics
in Cardiovascular Medicine
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