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Ibrutinib and Acalabrutinib Use and Risk of Atrial Fibrillation in Patients With Chronic B-cell Malignancies

NCT06561243 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 15000

Last updated 2024-08-21

No results posted yet for this study

Summary

Background. Ibrutinib and acalabrutinib are both associated with an increased risk of atrial fibrillation (AF) but AF comparative risk between these 2 BTK inhibitors (BTKis) remains largely unknown.

Objectives. Our aim was to examine the risk of developing incident AF with ibrutinib exposure compared with acalabrutinib exposure.

Methods. Using the TriNetX research network database, authors will conduct a retrospective cohort analysis of deidentified, aggregate adult patients with chronic B-cell malignancies and exposed to ibrutinib or acalabrutinib. Patients will be divided into 2 groups based on ibrutinib or acalabrutinib exposure. After propensity score matching (PSM), hazard ratios (HRs) and their associated 95% confidence intervals (CIs) will be used to compare AF risk during follow-up between the matched 2 groups.

Conditions

Interventions

DRUG

BTK inhibitor (Ibrutinib or Acalabrutinib)

Adult patients with a chronic B-cell malignancy included in this study will be separate into 2 groups according to the BTK inhibitor (ibrutinib and acalabrutinib)

Sponsors & Collaborators

  • University Hospital, Caen

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-25
Primary Completion
2024-09-30
Completion
2024-10-30
FDA Drug
Yes

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06561243 on ClinicalTrials.gov