Atrial Fibrillation Clinical Trial
Official title:
Is Ibrutinib-related Atrial Fibrillation Dose Dependent: Insights From the WHO Pharmacovigilance Database
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.
Status | Not yet recruiting |
Enrollment | 18000 |
Est. completion date | July 1, 2024 |
Est. primary completion date | May 1, 2024 |
Accepts healthy volunteers | |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - ibrutinib-related atrial fibrillation reports in Vigibase at the time of data extraction - involving adult patients - with an available ibrutinib daily dose Exclusion Criteria: - minors - no ibrutinib dose available |
Country | Name | City | State |
---|---|---|---|
France | Caen University Hospital, Department of Pharmacology | Caen | Normandie |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Caen |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | to determine the influence of ibrutinib dosing on IRAF reporting. Results were expressed as 2-by2 comparisons against the lowest dosing regimen (140mg/day). | Disproportionality estimates will be perform using both univariate and multivariate analyses and a global p-value will measure the difference between dosing regimen | Cases reported in the World Health Organization (WHO) of individual safety case reports to 26th July 2023 | |
Secondary | Description of ibrutinib-related atrial fibrillation cases | Clinical caracteristics of ibrutinib-related atrial fibrillation cases (sex, age, time to onset, hematological malignacy, coreported drugs, coreported adverse events) | Cases reported in the World Health Organization (WHO) of individual safety case reports to 26th July 2023 | |
Secondary | To determine the influence of ibrutinib dosing on IRAF reporting after exclusion of IRAF cases containing concurrent anticoagulant and/or antiarrhythmic drugs, assuming this approach could exclude reports with history of AF preceding IRAF reporting | Disproportionality estimates will be perform both univariate and multivariate analysesand a global p-value will measure the difference between dosing regimen | Cases reported in the World Health Organization (WHO) of individual safety case reports to 26th July 2023 | |
Secondary | To determine the influence of ibrutinib dosing on IRAF reporting according to the underlying chronic B-cell malignancy indication. | Disproportionality estimates will be perform using both univariate and multivariate analyses and a global p-value will measure the difference between dosing regimen | Cases reported in the World Health Organization (WHO) of individual safety case reports to 26th July 2023 | |
Secondary | To determine if the time to IRAF onset is dependent of the ibrutinib dosing regimen | We will use a linear regression to test if the association between ibrutinib-related atrial fibrillation reporting and time to onset is dependent of the dose regimen (the 140 mg/day ibrutinib dosing regimen will set as the reference) | Cases reported in the World Health Organization (WHO) of individual safety case reports to 26th July 2023 | |
Secondary | Sensitivity analysis will also be performed regarding the influence of ibrutinib dosing on 2 dose-dependent ADRs (neutropenia and thrombocytopenia) reporting related to ibrutinib exposure | Disproportionality estimates will be perform using univariate analysis and a global p-value will measure the difference between dosing regimen | Cases reported in the World Health Organization (WHO) of individual safety case reports to 26th July 2023 |
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