Search / Trial NCT06224452

Is Ibrutinib-related Atrial Fibrillation Dose Dependent

Launched by UNIVERSITY HOSPITAL, CAEN · Jan 24, 2024

Trial Information

Current as of December 30, 2024

Not yet recruiting

Keywords

ClinConnect Summary

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 estimat...

Gender

ALL

Eligibility criteria

  • 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

Trial Officials

Joachim Alexandre, MD

Principal Investigator

University Hospital, Caen

About University Hospital, Caen

The University Hospital of Caen is a leading academic medical institution dedicated to advancing healthcare through innovative research and clinical trials. As a prominent center for medical education and patient care in Normandy, France, it integrates cutting-edge scientific inquiry with compassionate clinical practice. The hospital collaborates with multidisciplinary teams to conduct rigorous studies aimed at improving treatment outcomes across various medical specialties. By fostering a collaborative environment, the University Hospital of Caen plays a pivotal role in translating research findings into effective therapeutic strategies, ultimately enhancing patient care and contributing to the global medical community.

Locations

Caen, Normandie, France

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0