NCT07283965

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

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 15,000 (estimated)
• Sponsor: University Hospital, Caen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Background. Zanubrutinib 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 zanubrutinib 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 zanubrutinib or acalabrutinib. Patients will be divided into 2 groups based on zanubrutinib or acalabrutinib exposure. After propensity score matching (PSM), Cox proportional hazard models will be used to calculate the hazard ratios (HRs) and 95% confidence intervals (CIs) to compare the 2 matched groups. The appropriateness of the proportional hazard assumption will be examined and risk differences (RDs) will be used if appropriate. Results will summarized with the use of Kaplan-Meier survival curves.

Conditions

• Chronic B-cell Malignancies
• BTK Inhibitors
• Cardiovascular Diseases

Interventions

Type	Name	Description
DRUG	Zanubrutinib	Adult patients with a chronic B-cell malignancy exposed to zanubrutinib
DRUG	Acalabrutinib	Adult patients with a chronic B-cell malignancy exposed to acalabrutinib

Timeline

• Start date: 2025-12-22
• Primary completion: 2026-01-15
• Completion: 2026-03-31
• First posted: 2025-12-16
• Last updated: 2025-12-16

Regulatory

• FDA-regulated drug study