Is Ibrutinib-related Atrial Fibrillation Dose Dependent

Sponsor
University Hospital, Caen
Study ID
NCT06224452
Status
Unknown

Conditions

Eligibility Criteria

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

Interventions

  • ibrutinib exposure — DRUG
    We will extract all atrial fibrillation cases involving adult patients associated with ibrutinib exposure with an available ibrutinib daily dose

Study Details

Ibrutinib, an oral inhibitor of Bruton tyrosine kinase (BTK), has recently revolutionized the treatment of various chronic B-cell malignancies and particularly chronic lymphocytic leukemia (CLL). Atrial fibrillation (AF) has early emerged as a cardiovascular adverse effect (CVAE) of ibrutinib but underlying mechanisms of IRAF are not fully understood. While a dose-reduction or an interruption of ibrutinib is mentioned in the summary of product characteristics of ibrutinib, any beneficial effect on IRAF management of such a management is unclear. The main aim of this study is to determine if IRAF is a dose-dependent CVAE in chronic B-cell malignancies patients by studying the association between ibrutinib dose and IRAF reporting in Vigibase®, the World Health Organization (WHO) pharmacovigilance database.

Key Dates

Start date
Mar 1, 2024
Status verified
Jan 2024
Primary completion
May 1, 2024
Completion
Jul 1, 2024

Study Design

Enrollment
18,000 participants (estimated)

Primary Outcome Measure

to determine the influence of ibrutinib dosing on IRAF reporting. Results were expressed as 2-by2 comparisons against the lowest dosing regimen (140mg/day). [ Time Frame: Cases reported in the World Health Organization (WHO) of individual safety case reports to 26th July 2023 ]

Central Contacts

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