History of Cardiovascular Disease Treated With RAS Blockers and With SARS-CoV-2 Infection Clinical Trial
— ACORES-2Official 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
| Verified date | April 2021 |
| Source | Assistance Publique - Hôpitaux de Paris |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Terminated |
| Enrollment | 44 |
| Est. completion date | January 9, 2021 |
| Est. primary completion date | December 9, 2020 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| France | Cardiologie, Groupe Hospitalier Pitié-Salpêtrière | Paris |
| Lead Sponsor | Collaborator |
|---|---|
| Assistance Publique - Hôpitaux de Paris | Groupe Hospitalier Pitié-Salpêtrière |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Time to clinical improvement from day 0 to day 28 (improvement of two points on a seven-category ordinal scale, or live discharge from the hospital, whichever comes first) | Time to clinical improvement from day 0 to day 28 (improvement of two points on a seven-category ordinal scale, or live discharge from the hospital, whichever comes first) | from day 0 to day 28 or hospital discharge | |
| Secondary | Primary safety endpoint: major adverse cardiac events defined as the composite of cardiovascular death, myocardial infarction, stroke or acute heart failure at day 28 | Major adverse cardiac events defined as the composite of cardiovascular death, myocardial infarction, stroke or acute heart failure at day 28 | at day 28 | |
| Secondary | Clinical status as assessed with the seven-category ordinal scale on days 7, 14 and 28. | Clinical status as assessed with the seven-category ordinal scale. The seven-category ordinal scale consisted of the following categories:
not hospitalized with resumption of normal activities not hospitalized, but unable to resume normal activities hospitalized, not requiring supplemental oxygen hospitalized, requiring supplemental oxygen hospitalized, requiring nasal high-flow oxygen therapy, noninvasive mechanical ventilation, or both hospitalized, requiring ECMO, invasive mechanical ventilation, or both death. |
at days 7, 14 and 28 | |
| Secondary | Number of days alive free of oxygen. | Number of days alive free of oxygen. | from day 0 to day 28 or hospital discharge | |
| Secondary | Number of days alive outside hospital until day28 | Number of days alive outside hospital | at day28 | |
| Secondary | Number of days alive free of intensive-care unit (ICU) admission or mechanical Ventilation (invasive or non-invasive) until day28 | Ventilation (invasive or non-invasive) | at day28 | |
| Secondary | Number of days alive free of mechanical ventilation (invasive or non-invasive) until day28 | Number of days alive free of mechanical ventilation (invasive or non-invasive) | at day28 | |
| Secondary | Number of days alive free of ICU admission until day28 | Number of days alive free of ICU admission | at day28 | |
| Secondary | Rate of all-cause mortality at day 28 | Rate of all-cause mortality | at day 28 | |
| Secondary | Rate of cardiovascular death at day 28 | Rate of cardiovascular death | at day 28 | |
| Secondary | Number of days alive free of acute kidney injury until hospital discharge | Number of days alive free of acute kidney injury | at day 28 to hospital discharge |