Ignite Creation Date:
2025-12-24 @ 1:41 PM
Ignite Modification Date:
2025-12-29 @ 12:10 PM
Study NCT ID:
NCT04329195
Status:
TERMINATED
Last Update Posted:
2021-04-09
First Post:
2020-03-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ACE Inhibitors or ARBs Discontinuation in Context of COVID-19 Pandemic
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 44}}, 'statusModule': {'whyStopped': 'insufficient recrutment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2020-04-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2021-01-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-08', 'studyFirstSubmitDate': '2020-03-28', 'studyFirstSubmitQcDate': '2020-03-28', 'lastUpdatePostDateStruct': {'date': '2021-04-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '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)', 'timeFrame': 'from day 0 to day 28 or hospital discharge', '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)'}], 'secondaryOutcomes': [{'measure': 'Primary safety endpoint: major adverse cardiac events defined as the composite of cardiovascular death, myocardial infarction, stroke or acute heart failure at day 28', 'timeFrame': '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'}, {'measure': 'Clinical status as assessed with the seven-category ordinal scale on days 7, 14 and 28.', 'timeFrame': 'at 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:\n\n1. not hospitalized with resumption of normal activities\n2. not hospitalized, but unable to resume normal activities\n3. hospitalized, not requiring supplemental oxygen\n4. hospitalized, requiring supplemental oxygen\n5. hospitalized, requiring nasal high-flow oxygen therapy, noninvasive mechanical ventilation, or both\n6. hospitalized, requiring ECMO, invasive mechanical ventilation, or both\n7. death.'}, {'measure': 'Number of days alive free of oxygen.', 'timeFrame': 'from day 0 to day 28 or hospital discharge', 'description': 'Number of days alive free of oxygen.'}, {'measure': 'Number of days alive outside hospital until day28', 'timeFrame': 'at day28', 'description': 'Number of days alive outside hospital'}, {'measure': 'Number of days alive free of intensive-care unit (ICU) admission or mechanical Ventilation (invasive or non-invasive) until day28', 'timeFrame': 'at day28', 'description': 'Ventilation (invasive or non-invasive)'}, {'measure': 'Number of days alive free of mechanical ventilation (invasive or non-invasive) until day28', 'timeFrame': 'at day28', 'description': 'Number of days alive free of mechanical ventilation (invasive or non-invasive)'}, {'measure': 'Number of days alive free of ICU admission until day28', 'timeFrame': 'at day28', 'description': 'Number of days alive free of ICU admission'}, {'measure': 'Rate of all-cause mortality at day 28', 'timeFrame': 'at day 28', 'description': 'Rate of all-cause mortality'}, {'measure': 'Rate of cardiovascular death at day 28', 'timeFrame': 'at day 28', 'description': 'Rate of cardiovascular death'}, {'measure': 'Number of days alive free of acute kidney injury until hospital discharge', 'timeFrame': 'at day 28 to hospital discharge', 'description': 'Number of days alive free of acute kidney injury'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['SARS-CoV-2', 'Cardiovascular disease', 'RAS blockers'], 'conditions': ['History of Cardiovascular Disease Treated With RAS Blockers and With SARS-CoV-2 Infection']}, 'descriptionModule': {'briefSummary': '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.\n\nIndividuals with a history of cardiovascular disease develop a more severe illness and have higher rates of death.\n\nBecause 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.\n\nIt is crucial to determine whether RAS blockers should be discontinued or not in patients with COVID-19.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years old.\n* Chronically treated with RAS blockers (ACE inhibitors or ARBs on the last prescription prior to admission with a treatment duration ≥ 1 month).\n* Diagnosis of COVID-19 confirmed by the presence of SARS-CoV-2 on any biological sample with any detection method.\n* Patients hospitalized in a non-intensive care unit.\n* Pregnancy test at inclusion visit for women of childbearing potential.\n* 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).\n\nExclusion Criteria:\n\n* Shock requiring vasoactive agents.\n* Acute respiratory distress syndrome requiring invasive mechanical ventilation.\n* Circulatory assistance.\n* History of malignant hypertension according to the definition of the 2018 ESC/ESH guidelines on hypertension.\n* Uncontrolled blood pressure despite the use of five antihypertensive drugs.\n* History of nephrotic syndrome.\n* History of hospitalization for hemorrhagic stroke in the past 3 months.\n* RAS blockers therapy previously stopped \\> 48h.\n* No affiliation to the French Health Care System "Sécurité Sociale".\n* Inability to obtain informed consent.'}, 'identificationModule': {'nctId': 'NCT04329195', 'acronym': 'ACORES-2', 'briefTitle': 'ACE Inhibitors or ARBs Discontinuation in Context of COVID-19 Pandemic', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'APHP200409'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1: discontinuation of RAS blocker therapy', 'description': 'discontinuation of RAS blocker therapy', 'interventionNames': ['Drug: 1: discontinuation of RAS blocker therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2: continuation of RAS blocker therapy', 'description': 'continuation of RAS blocker therapy', 'interventionNames': ['Drug: 2: continuation of RAS blocker therapy']}], 'interventions': [{'name': '1: discontinuation of RAS blocker therapy', 'type': 'DRUG', 'otherNames': ['discontinuation of RAS blocker therapy'], 'description': 'discontinuation of RAS blocker therapy', 'armGroupLabels': ['1: discontinuation of RAS blocker therapy']}, {'name': '2: continuation of RAS blocker therapy', 'type': 'DRUG', 'otherNames': ['continuation of RAS blocker therapy'], 'description': 'continuation of RAS blocker therapy', 'armGroupLabels': ['2: continuation of RAS blocker therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75013', 'city': 'Paris', 'country': 'France', 'facility': 'Cardiologie, Groupe Hospitalier Pitié-Salpêtrière', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Gilles MONTALESCOT, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institut Cardiologie - Pitié Salpêtrière(APHP) / ACTION Study Group / Univ. Paris 6 (UPMC) - INSERM UMRS 1166'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'collaborators': [{'name': 'Groupe Hospitalier Pitié-Salpêtrière', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}