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ACE Inhibitors or ARBs Discontinuation in Context of COVID-19 Pandemic (ACORES-2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04329195
Recruitment Status : Terminated (insufficient recrutment)
First Posted : April 1, 2020
Last Update Posted : April 9, 2021
Sponsor:
Collaborator:
Groupe Hospitalier Pitié-Salpêtrière
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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.


Condition or disease Intervention/treatment Phase
History of Cardiovascular Disease Treated With RAS Blockers and With SARS-CoV-2 Infection Drug: 1: discontinuation of RAS blocker therapy Drug: 2: continuation of RAS blocker therapy Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : April 9, 2020
Actual Primary Completion Date : December 9, 2020
Actual Study Completion Date : January 9, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 1: discontinuation of RAS blocker therapy
discontinuation of RAS blocker therapy
Drug: 1: discontinuation of RAS blocker therapy
discontinuation of RAS blocker therapy
Other Name: discontinuation of RAS blocker therapy

Active Comparator: 2: continuation of RAS blocker therapy
continuation of RAS blocker therapy
Drug: 2: continuation of RAS blocker therapy
continuation of RAS blocker therapy
Other Name: continuation of RAS blocker therapy




Primary Outcome Measures :
  1. 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 Frame: from day 0 to day 28 or hospital discharge ]
    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)


Secondary Outcome Measures :
  1. Primary safety endpoint: major adverse cardiac events defined as the composite of cardiovascular death, myocardial infarction, stroke or acute heart failure at day 28 [ Time Frame: at day 28 ]
    Major adverse cardiac events defined as the composite of cardiovascular death, myocardial infarction, stroke or acute heart failure at day 28

  2. Clinical status as assessed with the seven-category ordinal scale on days 7, 14 and 28. [ Time Frame: at 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:

    1. not hospitalized with resumption of normal activities
    2. not hospitalized, but unable to resume normal activities
    3. hospitalized, not requiring supplemental oxygen
    4. hospitalized, requiring supplemental oxygen
    5. hospitalized, requiring nasal high-flow oxygen therapy, noninvasive mechanical ventilation, or both
    6. hospitalized, requiring ECMO, invasive mechanical ventilation, or both
    7. death.

  3. Number of days alive free of oxygen. [ Time Frame: from day 0 to day 28 or hospital discharge ]
    Number of days alive free of oxygen.

  4. Number of days alive outside hospital until day28 [ Time Frame: at day28 ]
    Number of days alive outside hospital

  5. Number of days alive free of intensive-care unit (ICU) admission or mechanical Ventilation (invasive or non-invasive) until day28 [ Time Frame: at day28 ]
    Ventilation (invasive or non-invasive)

  6. Number of days alive free of mechanical ventilation (invasive or non-invasive) until day28 [ Time Frame: at day28 ]
    Number of days alive free of mechanical ventilation (invasive or non-invasive)

  7. Number of days alive free of ICU admission until day28 [ Time Frame: at day28 ]
    Number of days alive free of ICU admission

  8. Rate of all-cause mortality at day 28 [ Time Frame: at day 28 ]
    Rate of all-cause mortality

  9. Rate of cardiovascular death at day 28 [ Time Frame: at day 28 ]
    Rate of cardiovascular death

  10. Number of days alive free of acute kidney injury until hospital discharge [ Time Frame: at day 28 to hospital discharge ]
    Number of days alive free of acute kidney injury



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04329195


Locations
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France
Cardiologie, Groupe Hospitalier Pitié-Salpêtrière
Paris, France, 75013
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Groupe Hospitalier Pitié-Salpêtrière
Investigators
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Principal Investigator: Gilles MONTALESCOT, MD, PhD Institut Cardiologie - Pitié Salpêtrière(APHP) / ACTION Study Group / Univ. Paris 6 (UPMC) - INSERM UMRS 1166
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT04329195    
Other Study ID Numbers: APHP200409
First Posted: April 1, 2020    Key Record Dates
Last Update Posted: April 9, 2021
Last Verified: April 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Assistance Publique - Hôpitaux de Paris:
SARS-CoV-2
Cardiovascular disease
RAS blockers
Additional relevant MeSH terms:
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Infection
Cardiovascular Diseases