JOint Use of Database to Identify Risk Factors of CARDio-vascular Toxicity Induced by Immune Checkpoint Inhibitors (JOCARDITE)

Groupe Hospitalier Pitie-Salpetriere

Status: Enrolling

Conditions: Pericarditis; Myocarditis; Vasculitis; Cardiovascular Diseases; Heart Diseases; Cardiomyopathies

Treatments: Drug: ICI

Study type: Observational

Funder types: Other

Identifiers

NCT04294771

CIC1421-20-03

Details and patient eligibility

About

Immune checkpoint inhibitors (ICIs) might induce high grade immune-related adverse events (irAEs) involving the cardio-vascular system. This study investigates reports of cardio-vascular toxicity associated with treatment including anti-PD1, Anti-PDL-1, and Anti CTLA4 classes using the World Health Organization (WHO) database VigiBase, Assistance Publique Hopitaux de Paris Entrepot de Données de Santé (APHP.EDS), French Système National Des Données de Santé (SNDS) Databases and a retrospective international multicenter registry of ICI-associated myocarditis

Full description

ICIs have dramatically improved clinical outcomes in multiple cancer types and are increasingly being tested in earlier disease settings and in combination. Thus, irAEs can occur and risk factors for such events have been scarcely described. Here, the investigators will use VigiBase (http://www.vigiaccess.org/), the World Health Organization (WHO) database of individual safety case reports, to identify risk factors for cases of cardiovascular adverse drug reaction following treatment with ICIs, the investigators will also use two french databases : APHP Entrepot de Données de Santé (EDS), French Système National Des Données de Santé (SNDS) Databases and a retrospective international multicenter registry of ICI-associated myocarditis

Enrollment: 500,000 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Case reported in the World Health Organization (WHO) database of individual safety case reports to 01/01/2025
• Case reported in the APHP Entrepot de Données de Santé (EDS) database of individual safety case reports to 01/01/2025
• Case reported in the Système National Des Données de Santé (SNDS) Database of individual safety case reports to 01/01/2025
• Case reported in a retrospective international multicenter registry of ICI-associated myocarditis to 01/01/2025
• Adverse event reported were including the MedDRA terms: Cardiac and vascular investigations (excl enzyme tests) (HLGT), Vascular disorders (SOC), Skeletal and cardiac muscle analyses (HLT), Sudden death (PT), Sudden cardiac death (PT), Cardiac disorders (SOC), Cardiac arrhythmias (HLGT), Cardiac disorder signs and symptoms (HLGT), Cardiac neoplasms (HLGT), Cardiac valve disorders (HLGT), Congenital cardiac disorders (HLGT), Coronary artery disorders (HLGT), Endocardial disorders (HLGT), Heart failures (HLGT), Myocardial disorders (HLGT), Pericardial disorders (HLGT)
• Patients treated with ICIs included in the ATC: Ipilimumab (L01XC11), Nivolumab (L01XC17), Pembrolizumab (L01XC18), Durvalumab (L01XC28), Avelumab (L01XC31), Atezolizumab (L01XC32), Cemiplimab (L01XC33)

Exclusion criteria

• Chronology not compatible between the drug and the toxicity

Trial design

500,000 participants in 2 patient groups

Myocarditis and other cardiovascular toxicities ICI-related

Description:

Case reported in the World Health Organization (WHO)international pharmacovigilance database, or APHP Entrepot de Données de Santé (EDS) and French Système National Des Données de Santé (SNDS) Databases, with a chronology compatible with the drug toxicity

Treatment:

Drug: ICI

Non case

Description:

Non-case will be patients exposed to ICI without cardiovascular toxicities

Treatment:

Drug: ICI