Official Title
ACE Inhibitors or ARBs Discontinuation for Clinical Outcome Risk Reduction in Patients Hospitalized for the Endemic Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV-2) Infection: the Randomized ACORES-2 Study
Brief Summary

Since December 2019, a novel coronavirus called SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2) has caused an international outbreak of respiratory illness described as COVID-19. Individuals with a history of cardiovascular disease develop a more severe illness and have higher rates of death. Because of the potential interaction between RAS blockers and SARS-CoV-2 mechanism of infection, there are ongoing scientific discussions on whether they should be stopped or continued in patients with COVID-19. It is crucial to determine whether RAS blockers should be discontinued or not in patients with COVID-19.

Terminated
History of Cardiovascular Disease Treated With RAS Blockers and With SARS-CoV-2 Infection

Drug: 1: discontinuation of RAS blocker therapy

discontinuation of RAS blocker therapy
Other Name: discontinuation of RAS blocker therapy

Drug: 2: continuation of RAS blocker therapy

continuation of RAS blocker therapy
Other Name: continuation of RAS blocker therapy

Eligibility Criteria

Inclusion Criteria:

- Age ≥ 18 years old.

- Chronically treated with RAS blockers (ACE inhibitors or ARBs on the last prescription
prior to admission with a treatment duration ≥ 1 month).

- Diagnosis of COVID-19 confirmed by the presence of SARS-CoV-2 on any biological sample
with any detection method.

- Patients hospitalized in a non-intensive care unit.

- Pregnancy test at inclusion visit for women of childbearing potential.

- Women of childbearing potential must agree to use adequate contraception according to
recommendations related to contraception and pregnancy testing in clinical trials, by
Clinical Trial Facilitation Group (CTFG).

Exclusion Criteria:

- Shock requiring vasoactive agents.

- Acute respiratory distress syndrome requiring invasive mechanical ventilation.

- Circulatory assistance.

- History of malignant hypertension according to the definition of the 2018 ESC/ESH
guidelines on hypertension.

- Uncontrolled blood pressure despite the use of five antihypertensive drugs.

- History of nephrotic syndrome.

- History of hospitalization for hemorrhagic stroke in the past 3 months.

- RAS blockers therapy previously stopped > 48h.

- No affiliation to the French Health Care System "Sécurité Sociale".

- Inability to obtain informed consent.

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
France
Locations

Cardiologie, Groupe Hospitalier Pitié-Salpêtrière
Paris, France

Gilles MONTALESCOT, MD, PhD, Principal Investigator
Institut Cardiologie - Pitié Salpêtrière(APHP) / ACTION Study Group / Univ. Paris 6 (UPMC) - INSERM UMRS 1166

Groupe Hospitalier Pitié-Salpêtrière
NCT Number
Keywords
SARS-CoV-2
Cardiovascular disease
RAS blockers
MeSH Terms
Infections
COVID-19
Cardiovascular Diseases