Ignite Creation Date:
2025-12-24 @ 7:52 PM
Ignite Modification Date:
2026-03-29 @ 4:54 AM
Study NCT ID:
NCT03243604
Status:
COMPLETED
Last Update Posted:
2018-10-18
First Post:
2017-07-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
cARdiotoxicity Profile of aBIraTeRone in prostAte Cancer : a pharmacoviGilancE Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D001281', 'term': 'Atrial Fibrillation'}, {'id': 'D013617', 'term': 'Tachycardia, Supraventricular'}, {'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D066126', 'term': 'Cardiotoxicity'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D013610', 'term': 'Tachycardia'}, {'id': 'D000075224', 'term': 'Cardiac Conduction System Disease'}, {'id': 'D064420', 'term': 'Drug-Related Side Effects and Adverse Reactions'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D011832', 'term': 'Radiation Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012739', 'term': 'Gonadal Steroid Hormones'}], 'ancestors': [{'id': 'D042341', 'term': 'Gonadal Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1717}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-05-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2017-07-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-10-17', 'studyFirstSubmitDate': '2017-07-20', 'studyFirstSubmitQcDate': '2017-08-04', 'lastUpdatePostDateStruct': {'date': '2018-10-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-07-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Analysis of disproportionality of reports for cardiotoxicity associated with abiraterone as compared to enzalutamide by performing a case- non-case study', 'timeFrame': '2 months', 'description': 'Analysis of disproportionality of reports for cardiotoxicity associated with abiraterone as compared to enzalutamide by performing a case- non-case study'}], 'secondaryOutcomes': [{'measure': 'Compare the reporting of suspected drug-induced supraventricular arrhythmias with abiraterone as compared to enzalutamide by performing a disproportionality analysis', 'timeFrame': '2 months', 'description': 'Compare the reporting of suspected drug-induced supraventricular arrhythmias with abiraterone as compared to enzalutamide by performing a disproportionality analysis'}, {'measure': 'Compare the reporting of drug-induced cardiac failure with abiraterone as compared to enzalutamide by performing a disproportionality analysis', 'timeFrame': '2 months', 'description': 'Compare the reporting of drug-induced cardiac failure with abiraterone as compared to enzalutamide by performing a disproportionality analysis'}, {'measure': 'Compare the reporting of drug-induced cardiac failure and/or supraventricular arrhythmias with abiraterone as compared to other androgen-deprivation therapies by performing a disproportionality analysis', 'timeFrame': '2 months', 'description': 'Compare the reporting of drug-induced cardiac failure and/or supraventricular arrhythmias with abiraterone as compared to other androgen-deprivation therapies by performing a disproportionality analysis'}, {'measure': 'Description of other mineralocorticoid related adverse events (hypokaliemia, fluid retention, and hypertension) when the cardio toxicity occurs', 'timeFrame': '2 months', 'description': 'Description of other mineralocorticoid related adverse events (hypokaliemia, fluid retention, and hypertension) when the cardio toxicity occurs'}, {'measure': 'Description of the population of patients having a cardio-vascular adverse event', 'timeFrame': '2 months', 'description': 'Description of the population of patients having a cardio-vascular adverse event'}, {'measure': 'Description of the duration of treatment when the toxicity happens (role of cumulative dose)', 'timeFrame': '2 months', 'description': 'Description of the duration of treatment when the toxicity happens (role of cumulative dose)'}, {'measure': 'Description of the drug-drug interactions associated with adverse events', 'timeFrame': '2 months', 'description': 'Description of the drug-drug interactions associated with adverse events'}, {'measure': 'Causality assessment of reported cardiovascular events according to the WHO-UMC system', 'timeFrame': '2 months', 'description': 'Causality assessment of reported cardiovascular events according to the WHO-UMC system'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cardiotoxicity', 'abiraterone acetate', 'androgen antagonist'], 'conditions': ['Arrhythmias, Cardiac', 'Atrial Fibrillation and Flutter', 'Tachycardia, Supraventricular', 'Cardiac Failure']}, 'descriptionModule': {'briefSummary': 'Abiraterone associated with prednisone is used in prostate cancer. Abiraterone is a selective small-molecule inhibiting cytochrome P450 17A1 (CYP17A1), a key enzyme in androgen synthesis.\n\nCYP17A inhibition is also responsible for mineral corticosteroid related adverse events as hypokaliemia, fluid retention, and hypertension. Primary hyperaldosteronism is associated with cardiovascular toxicities such as atrial fibrillation and cardiac failure. Other androgen-deprivation therapies are not associated with increased mineral corticosteroid level.\n\nThis study investigates reports of cardiovascular toxicities for treatment including L02 (sex hormones used in treatment of neoplastic diseases), and G03 (sex hormones) used in prostate cancer in the French pharmacovigilance database and in the EudraCT database.', 'detailedDescription': 'Due to its peculiar pharmacology, abiraterone is potentially associated with more cardiotoxicity as compared to other androgen-deprivation therapies. This study investigates the main characteristics of patients affected by cardiovascular side effects of which supraventricular arrhythmias (including atrial fibrillation, atrial flutter, supraventricular tachycardia), and cardiac failure imputed to drugs classified as L02, and G03 according to anatomical therapeutic chemical (ATC) classification. A causality assessment according to the World Health Organization-The Uppsala Monitoring Centre (WHO-UMC) is systematically applied.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The population is selected in the French pharmacovigilance database and EudraCT database from 01/01/1985 to May 2017 and included patients treated with hormonal therapies included in the ATC L02, and G03', 'genderDescription': 'Male', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Case reported in the French pharmacovigilance database from 01/01/1985 to 16/05/2017\n* Case reported in the EudraCT database to May 2017\n* Adverse event reported were including the MedDRA terms: SOC Cardiac Disorders; SOC Vascular Disorders; HLT Death, Sudden Death; HLGT Water, electrolyte and mineral investigations; HLGT Cardiac and vascular investigations (excl enzyme tests); and PT Syncope.\n* Patients treated with hormonal therapies included in the ATC L02, and G03\n\nExclusion Criteria:\n\n* Chronology not compatible between the drug and the toxicity'}, 'identificationModule': {'nctId': 'NCT03243604', 'acronym': 'ARBITRAGE', 'briefTitle': 'cARdiotoxicity Profile of aBIraTeRone in prostAte Cancer : a pharmacoviGilancE Study', 'organization': {'class': 'OTHER', 'fullName': 'Groupe Hospitalier Pitie-Salpetriere'}, 'officialTitle': 'Cardiotoxicity of Abiraterone in the National French Pharmacovigilance Database and in the European Clinical Trials Database (EudraCT)', 'orgStudyIdInfo': {'id': 'CIC1421-17-08'}}, 'armsInterventionsModule': {'interventions': [{'name': 'L02 (sex hormones used in treatment of neoplastic diseases) and G03 (sex hormones)', 'type': 'DRUG', 'description': 'Androgen-deprivation therapies including L02 (sex hormones used in treatment of neoplastic diseases), and G03 (sex hormones)'}]}, 'contactsLocationsModule': {'locations': [{'zip': '75013', 'city': 'Paris', 'state': 'Île-de-France Region', 'country': 'France', 'facility': 'Centre Régional de Pharmaco-vigilance - Paris, Pitié-Salpétrière', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Groupe Hospitalier Pitie-Salpetriere', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'Joe Elie Salem', 'investigatorAffiliation': 'Groupe Hospitalier Pitie-Salpetriere'}}}}