Is Ibrutinib-related Atrial Fibrillation Dose Dependent

Status Not yet recruiting

Clinical Trial Summary

Clinical Trial Description

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. In phase 3 randomized clinical trials (RCT), ibrutinib exhibits a ≈4-fold increase-risk of AF compared with controls (pooled relative-risk (RR) 3.9; 95% confidence interval (CI): (2.0-7.5); p<0.0001). The annualized incidence rate of ibrutinib-related AF (IRAF) reporting in clinical trials is estimated to 4.9 (95% CI: 2.9-8.3) per 100 person-years. IRAF risk persists throughout ibrutinib exposition and seems to be cumulative with the extension of follow-up and cardiac monitoring. Underlying mechanisms of IRAF are not fully understood. Ibrutinib potently inhibits multiple off-target kinases at therapeutic concentrations. 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06224452
Study type	Observational
Source	University Hospital, Caen
Contact	Joachim Alexandre, MD
Phone	+33231064670
Email	alexandre-j@chu-caen.fr
Status	Not yet recruiting
Phase
Start date	March 1, 2024
Completion date	July 1, 2024

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05654272` - Development of CIRC Technologies
Completed	`NCT04571385` - A Study Evaluating the Efficacy and Safety of AP30663 for Cardioversion in Participants With Atrial Fibrillation (AF)	Phase 2
Terminated	`NCT04115735` - His Bundle Recording From Subclavian Vein
Completed	`NCT05366803` - Women's Health Initiative Silent Atrial Fibrillation Recording Study	N/A
Completed	`NCT02864758` - Benefit-Risk Of Arterial THrombotic prEvention With Rivaroxaban for Atrial Fibrillation in France
Recruiting	`NCT05442203` - Electrocardiogram-based Artificial Intelligence-assisted Detection of Heart Disease	N/A
Completed	`NCT05599308` - Evaluation of Blood Pressure Monitor With AFib Screening Feature	N/A
Completed	`NCT03790917` - Assessment of Adherence to New Oral anTicoagulants in Atrial Fibrillation patiEnts Within the Outpatient registrY
Enrolling by invitation	`NCT05890274` - Atrial Fibrillation (AF) and Electrocardiogram (EKG) Interpretation Project ECHO	N/A
Recruiting	`NCT05266144` - Atrial Fibrillation Patients Treated With Catheter Ablation
Recruiting	`NCT05316870` - Construction and Effect Evaluation of Anticoagulation Management Model in Atrial Fibrillation	N/A
Not yet recruiting	`NCT06023784` - The Impact of LBBAP vs RVP on the Incidence of New-onset Atrial Fibrillation in Patients With Atrioventricular Block	N/A
Recruiting	`NCT05572814` - Transform: Teaching, Technology, and Teams	N/A
Recruiting	`NCT04092985` - Smart Watch iECG for the Detection of Cardiac Arrhythmias
Completed	`NCT04087122` - Evaluate the Efficiency Impact of Conducting Active Temperature Management During Cardiac Cryoablation Procedures	N/A
Completed	`NCT06283654` - Relieving the Emergency Department by Using a 1-lead ECG Device for Atrial Fibrillation Patients After Pulmonary Vein Isolation
Recruiting	`NCT05416086` - iCLAS™ Cryoablation System Post-Market Clinical Follow-up (PMCF) Study	N/A
Completed	`NCT05067114` - Solutions for Atrial Fibrillation Edvocacy (SAFE)
Completed	`NCT04546763` - Study Watch AF Detection At Home
Completed	`NCT03761394` - Pulsewatch: Smartwatch Monitoring for Atrial Fibrillation After Stroke	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.