Search / Trial NCT06224452

Is Ibrutinib-related Atrial Fibrillation Dose Dependent

Launched by UNIVERSITY HOSPITAL, CAEN · Jan 24, 2024

Trial Information

Current as of October 03, 2024

Not yet recruiting

Keywords

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 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

About Sponsor

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

Locations

Caen, Normandie, France

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0