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

NCT04329195 | Terminated Phase 3 DMC

• 1 other identifier: APHP200409
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

SARS-CoV-2; Cardiovascular disease; RAS blockers

Outcome Measures

Primary Outcomes (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 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 Outcomes (10)

• Primary safety endpoint: major adverse cardiac events defined as the composite of cardiovascular death, myocardial infarction, stroke or acute heart failure at day 28

  at day 28

• Clinical status as assessed with the seven-category ordinal scale on days 7, 14 and 28.

  at days 7, 14 and 28

• Number of days alive free of oxygen.

  from day 0 to day 28 or hospital discharge

• Number of days alive outside hospital until day28

  at day28

• Number of days alive free of intensive-care unit (ICU) admission or mechanical Ventilation (invasive or non-invasive) until day28

  at day28

Study Arms (2)

1: discontinuation of RAS blocker therapy

EXPERIMENTAL

discontinuation of RAS blocker therapy

Drug: 1: discontinuation of RAS blocker therapy

2: continuation of RAS blocker therapy

ACTIVE COMPARATOR

continuation of RAS blocker therapy

Drug: 2: continuation of RAS blocker therapy

Interventions

1: discontinuation of RAS blocker therapy DRUG

discontinuation of RAS blocker therapy

Also known as: discontinuation of RAS blocker therapy

1: discontinuation of RAS blocker therapy

2: continuation of RAS blocker therapy DRUG

continuation of RAS blocker therapy

Also known as: continuation of RAS blocker therapy

2: continuation of RAS blocker therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Groupe Hospitalier Pitié-Salpêtrière: collaborator

Study Sites (1)

Cardiologie, Groupe Hospitalier Pitié-Salpêtrière

Paris, 75013, France

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

• Gilles MONTALESCOT, MD, PhD

  Institut Cardiologie - Pitié Salpêtrière(APHP) / ACTION Study Group / Univ. Paris 6 (UPMC) - INSERM UMRS 1166

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2020
• First Posted: April 1, 2020
• Study Start: April 9, 2020
• Primary Completion: December 9, 2020
• Study Completion: January 9, 2021
• Last Updated: April 9, 2021

Record last verified: 2021-04

Locations

FR (1)