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

Primary Purpose

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

Status
Terminated
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
1: discontinuation of RAS blocker therapy
2: continuation of RAS blocker therapy
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for History of Cardiovascular Disease Treated With RAS Blockers and With SARS-CoV-2 Infection focused on measuring SARS-CoV-2, Cardiovascular disease, RAS blockers

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Cardiologie, Groupe Hospitalier Pitié-Salpêtrière

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1: discontinuation of RAS blocker therapy

2: continuation of RAS blocker therapy

Arm Description

discontinuation of RAS blocker therapy

continuation of RAS blocker therapy

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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
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.
Number of days alive free of oxygen.
Number of days alive free of oxygen.
Number of days alive outside hospital until day28
Number of days alive outside hospital
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)
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)
Number of days alive free of ICU admission until day28
Number of days alive free of ICU admission
Rate of all-cause mortality at day 28
Rate of all-cause mortality
Rate of cardiovascular death at day 28
Rate of cardiovascular death
Number of days alive free of acute kidney injury until hospital discharge
Number of days alive free of acute kidney injury

Full Information

First Posted
March 28, 2020
Last Updated
April 8, 2021
Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Groupe Hospitalier Pitié-Salpêtrière
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1. Study Identification

Unique Protocol Identification Number
NCT04329195
Brief Title
ACE Inhibitors or ARBs Discontinuation in Context of COVID-19 Pandemic
Acronym
ACORES-2
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Terminated
Why Stopped
insufficient recrutment
Study Start Date
April 9, 2020 (Actual)
Primary Completion Date
December 9, 2020 (Actual)
Study Completion Date
January 9, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Groupe Hospitalier Pitié-Salpêtrière

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
History of Cardiovascular Disease Treated With RAS Blockers and With SARS-CoV-2 Infection
Keywords
SARS-CoV-2, Cardiovascular disease, RAS blockers

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1: discontinuation of RAS blocker therapy
Arm Type
Experimental
Arm Description
discontinuation of RAS blocker therapy
Arm Title
2: continuation of RAS blocker therapy
Arm Type
Active Comparator
Arm Description
continuation of RAS blocker therapy
Intervention Type
Drug
Intervention Name(s)
1: discontinuation of RAS blocker therapy
Other Intervention Name(s)
discontinuation of RAS blocker therapy
Intervention Description
discontinuation of RAS blocker therapy
Intervention Type
Drug
Intervention Name(s)
2: continuation of RAS blocker therapy
Other Intervention Name(s)
continuation of RAS blocker therapy
Intervention Description
continuation of RAS blocker therapy
Primary Outcome Measure Information:
Title
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)
Description
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
Secondary Outcome Measure Information:
Title
Primary safety endpoint: major adverse cardiac events defined as the composite of cardiovascular death, myocardial infarction, stroke or acute heart failure at day 28
Description
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
Title
Clinical status as assessed with the seven-category ordinal scale on days 7, 14 and 28.
Description
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.
Time Frame
at days 7, 14 and 28
Title
Number of days alive free of oxygen.
Description
Number of days alive free of oxygen.
Time Frame
from day 0 to day 28 or hospital discharge
Title
Number of days alive outside hospital until day28
Description
Number of days alive outside hospital
Time Frame
at day28
Title
Number of days alive free of intensive-care unit (ICU) admission or mechanical Ventilation (invasive or non-invasive) until day28
Description
Ventilation (invasive or non-invasive)
Time Frame
at day28
Title
Number of days alive free of mechanical ventilation (invasive or non-invasive) until day28
Description
Number of days alive free of mechanical ventilation (invasive or non-invasive)
Time Frame
at day28
Title
Number of days alive free of ICU admission until day28
Description
Number of days alive free of ICU admission
Time Frame
at day28
Title
Rate of all-cause mortality at day 28
Description
Rate of all-cause mortality
Time Frame
at day 28
Title
Rate of cardiovascular death at day 28
Description
Rate of cardiovascular death
Time Frame
at day 28
Title
Number of days alive free of acute kidney injury until hospital discharge
Description
Number of days alive free of acute kidney injury
Time Frame
at day 28 to hospital discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gilles MONTALESCOT, MD, PhD
Organizational Affiliation
Institut Cardiologie - Pitié Salpêtrière(APHP) / ACTION Study Group / Univ. Paris 6 (UPMC) - INSERM UMRS 1166
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cardiologie, Groupe Hospitalier Pitié-Salpêtrière
City
Paris
ZIP/Postal Code
75013
Country
France

12. IPD Sharing Statement

Learn more about this trial

ACE Inhibitors or ARBs Discontinuation in Context of COVID-19 Pandemic

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