Browsing by Author "Macedo, Ariane Vieira Scarlatelli"

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    Continuing versus suspending angiotensin-converting enzyme inhibitors and angiotensin receptor blockers: Impact on adverse outcomes in hospitalized patients with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)--The BRACE CORONA Trial.
    (American heart journal, 2020-08) Lopes, Renato D; Macedo, Ariane Vieira Scarlatelli; de Barros E Silva, Pedro Gabriel Melo; Moll-Bernardes, Renata Junqueira; Feldman, Andre; D'Andréa Saba Arruda, Guilherme; de Souza, Andrea Silvestre; de Albuquerque, Denilson Campos; Mazza, Lilian; Santos, Mayara Fraga; Salvador, Natalia Zerbinatti; Gibson, C Michael; Granger, Christopher B; Alexander, John H; de Souza, Olga Ferreira; BRACE CORONA investigators
    Angiotensin-converting enzyme-2 (ACE2) expression may increase due to upregulation in patients using angiotensin-converting enzyme inhibitors (ACEI) and angiotensin receptor blockers (ARBs). Because renin-angiotensin system blockers increase levels of ACE2, a protein that facilitates coronavirus entry into cells, there is concern that these drugs could increase the risk of developing a severe and fatal form of COVID-19. The impact of discontinuing ACEI and ARBs in patients with COVID-19 remains uncertain. DESIGN: BRACE CORONA is a pragmatic, multicenter, randomized, phase IV, clinical trial that aims to enroll around 500 participants at 34 sites in Brazil. Participants will be identified from an ongoing national registry of suspected and confirmed cases of COVID-19. Eligible patients using renin-angiotensin system blockers (ACEI/ARBs) with a confirmed diagnosis of COVID-19 will be randomized to a strategy of continued ACEI/ARB treatment versus temporary discontinuation for 30 days. The primary outcome is the median days alive and out of the hospital at 30 days. Secondary outcomes include progression of COVID-19 disease, all-cause mortality, death from cardiovascular causes, myocardial infarction, stroke, transient ischemic attack, new or worsening heart failure, myocarditis, pericarditis, arrhythmias, thromboembolic events, hypertensive crisis, respiratory failure, hemodynamic decompensation, sepsis, renal failure, and troponin, B-type natriuretic peptide (BNP), N-terminal-proBNP, and D-dimer levels. SUMMARY: BRACE CORONA will evaluate whether the strategy of continued ACEI/ARB therapy compared with temporary discontinuation of these drugs impacts clinical outcomes among patients with COVID-19.
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    Continuing versus suspending angiotensin-converting enzyme inhibitors and angiotensin receptor blockers: Impact on adverse outcomes in hospitalized patients with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
    (American heart journal, 2020-05-13) Lopes, Renato D; Macedo, Ariane Vieira Scarlatelli; de Barros E Silva, Pedro Gabriel Melo; Moll-Bernardes, Renata Junqueira; Feldman, Andre; D'Andréa Saba Arruda, Guilherme; de Souza, Andrea Silvestre; de Albuquerque, Denilson Campos; Mazza, Lilian; Santos, Mayara Fraga; Salvador, Natalia Zerbinatti; Gibson, C Michael; Granger, Christopher B; Alexander, John H; de Souza, Olga Ferreira
    Background:Angiotensin-converting enzyme-2 (ACE2) may increase due to upregulation in patients using angiotensin-converting enzyme inhibitors (ACEI) and angiotensin receptor blockers (ARB). Because renin-angiotensin system blockers increase levels of ACE2, a protein that facilitates coronavirus entry into cells, there is concern that these drugs could increase the risk of developing a severe and fatal form of COVID-19. The impact of discontinuing ACEI and ARBs in patients with COVID-19 remains uncertain.DESIGNBRACE CORONA is a pragmatic, multicenter, randomized, phase IV, clinical trial that aims to enroll around 500 participants at 32 sites in Brazil. Participants will be identified from an ongoing national registry of suspected and confirmed cases of COVID-19. Eligible patients using renin-angiotensin system blockers (ACEI/ARBs) with a confirmed diagnosis of COVID-19 will be randomized to a strategy of continued ACEI/ARB treatment versus temporary discontinuation for 30 days. The primary outcome is the median days alive and out of the hospital at 30 days. Secondary outcomes include progression of COVID-19 disease, all-cause mortality, death from vascular causes, myocardial infarction, stroke, transient ischemic attack, new or worsening heart failure, myocarditis, pericarditis, arrhythmias, thromboembolic events, hypertensive crisis, respiratory failure, hemodynamic decompensation, sepsis, renal failure, troponin, B-type natriuretic peptide, N-terminal-pro hormone and D-dimer levels. Summary:BRACE CORONA will evaluate whether the strategy of continued ACEI/ARB therapy compared with temporary discontinuation of these drugs impacts clinical outcomes among patients with COVID-19.
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    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, 2021-04-20) Lopes, Renato D; de Barros E Silva, Pedro Gabriel Melo; Furtado, Remo HM; Macedo, Ariane Vieira Scarlatelli; Ramacciotti, Eduardo; Damini, Lucas Petri; Bronhara, Bruna; Cavalcanti, Alexandre B; Rosa, Regis G; Azevedo, Luciano CP; Veiga, Viviane C; Machado, Flávia R; Ritt, Luiz Eduardo; Martins, Priscilla de Aquino; Alexander, John H; Avezum, Alvaro; Berwanger, Otavio; Coalition COVID-19 Brazil IV Investigators

    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) 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.

    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. CLINICALTRIALS.GOV: : NCT04394377.