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insufficient recrutment
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| Name | Class |
|---|---|
| Groupe Hospitalier Pitie-Salpetriere | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1: discontinuation of RAS blocker therapy | Experimental | discontinuation of RAS blocker therapy |
|
| 2: continuation of RAS blocker therapy | Active Comparator | continuation of RAS blocker therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 1: discontinuation of RAS blocker therapy | Drug | discontinuation of RAS blocker therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gilles MONTALESCOT, MD, PhD | Institut Cardiologie - Pitié Salpêtrière(APHP) / ACTION Study Group / Univ. Paris 6 (UPMC) - INSERM UMRS 1166 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cardiologie, Groupe Hospitalier Pitié-Salpêtrière | Paris | 75013 | France |
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| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
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| 2: continuation of RAS blocker therapy | Drug | continuation of RAS blocker therapy |
|
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| 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:
|
| at days 7, 14 and 28 |
| Number of days alive free of oxygen. | Number of days alive free of oxygen. | from day 0 to day 28 or hospital discharge |
| Number of days alive outside hospital until day28 | Number of days alive outside hospital | at day28 |
| 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 |
| 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 |
| Number of days alive free of ICU admission until day28 | Number of days alive free of ICU admission | at day28 |
| Rate of all-cause mortality at day 28 | Rate of all-cause mortality | at day 28 |
| Rate of cardiovascular death at day 28 | Rate of cardiovascular death | at day 28 |
| 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 |