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

Sponsor
Groupe Hospitalier Pitie-Salpetriere
Study ID
NCT04294771
Status
Recruiting
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Conditions

  • Cardiomyopathies
  • Cardiovascular Diseases
  • Heart Diseases
  • Myocarditis
  • Pericarditis
  • Vasculitis

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • ICI — DRUG
    Immune checkpoint inhibitor targeting either PD-1, PD-L1 or CTLA-4, and included in the ATC following list (ATC classification): Ipilimumab (L01XC11), Nivolumab (L01XC17), Pembrolizumab (L01XC18), Durvalumab (L01XC28), Avelumab (L01XC31), Atezolizumab (L01XC3)

Study Details

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

Key Dates

First listed
Mar 4, 2020
Start date
Jan 1, 2019
Status verified
Sep 2026
Primary completion
Jan 1, 2030
Completion
Jan 1, 2030

Study Design

Enrollment
500,000 participants (estimated)

Arms

  • Arm: Myocarditis and other cardiovascular toxicities ICI-related
    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
  • Arm: Non case
    Non-case will be patients exposed to ICI without cardiovascular toxicities

Primary Outcome Measure

Identifying risk factors of cardio-vascular toxicity of ICIs. [ Time Frame: Case reported in VigiBase, APHP Entrepot de Données de Santé (EDS), Système National Des Données de Santé (SNDS) Databases and a retrospective international multicenter registry of ICI-associated myocarditis from inception to January 2025 ]

Central Contacts

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