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 - 19/06/21
, Pedro Gabriel Melo de Barros e Silva, MD, PhD b, c, d, Remo H.M. Furtado, MD, PhD e, f, Ariane Vieira Scarlatelli Macedo, MD, MSc b, Eduardo Ramacciotti, MD, PhD b, Lucas Petri Damini, MS b, c, Bruna Bronhara, MS b, Alexandre B. Cavalcanti, MD, PhD c, g, Regis G. Rosa, MD, PhD h, i, Luciano C.P. Azevedo, MD, PhD h, i, Viviane C. Veiga, MD, PhD h, j, Flávia R Machado, MD, PhD h, k, Luiz Eduardo Ritt, MD, PhD l, m, Priscilla de Aquino Martins, MD, MSc n, John H. Alexander, MD, MHS a, Alvaro Avezum, MD, PhD o, Otavio Berwanger, MD, PhD eon behalf of the
Coalition COVID-19 Brazil IV Investigators
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Riassunto |
Background |
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.
Design |
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) vs standard of care with any approved venous thromboembolism 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 efficacy outcomes: incidence of venous thromboembolism , 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.
Summary |
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.
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| ☆ | ClinicalTrials.gov NCT04394377. |
| ☆☆ | Disclosures: RDL: Research support from Bristol-Myers Squibb, GlaxoSmithKline, Medtronic, Pfizer; Consulting fees from Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Daiichi-Sankyo, GlaxoSmithKline, Medtronic, Merck, Pfizer, Portola. PGMBS: Research support from Pfizer, Bayer and Roche Diagnostics; Consulting fees from Pfizer, Bayer and Roche Diagnostics. RHMF: Research grants and personal fees from AstraZeneca, Bayer; and Servier; and research grants from Pfizer, EMS, Aché, Brazilian Ministry of Health, and University Health Network. AVSM: Consulting fees from Pfizer, Bayer, Novartis, Daiichi-Sankyo, Zodiac and Roche. ER: Speaker's bureau for Bayer, BMS/PFE, Aspen, BI, Daiichi Sankyo. Consultant/advisor for Pfizer, BMS, Bayer, Sanofi, Amgen, Daiichi-Sankyo, Cristalia and Aspen.LPD: No conflict of interests. BB: No conflict of interests. ABC: Grants from Bayer, Bactiguard, Johnson & Johnson, do Brasil, Hemaclear, Hillrom, and Pfizer.RGR: No conflict of interests. LCPA: Research support from Aché, consulting fees from Halex-Istar and personal fees from Baxter. VCV: No conflict of interests. FRM: No conflict of interests. LER: Consulting fees from Pfizer. PAM: No conflict of interests. JHA: Research Support from Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, CryoLife, CSL Behring, Ferring, GlaxoSmithKline, U.S. FDA, U.S. NIH, XaTek and consulting fees or honoraria from AbbVie, Atricure, Bristol-Myers Squibb, CryoLife, GlaxoSmithKline, Janssen, Pfizer, Portola, and the U.S. VA CSP. AA: Research grants from Bayer, Sanofi-Pasteur, Population Health Research Institute. OB: Grants from AstraZeneca, Novartis, Servier, Bayer, Amgen, and Boehringer-Ingelheim. |
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