NCT07283965Not yet recruiting
Zanubrutinib and Acalabrutinib Use and Risk of Atrial Fibrillation in Patients With Chronic B-cell Malignancies
Source: ClinicalTrials.gov · Last updated 16 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 15000 (estimated)
- First submitted
- 26 Nov 2025
- Start date
- 22 Dec 2025
- Primary completion date
- 15 Jan 2026
- Lead sponsor
- University Hospital, Caen
- Diseases
- Atrial fibrillation
- NCT number
- NCT07283965
What you commit to
- Study type: Observational
- Planned participants: 15000
- From 22 Dec 2025 to the primary completion date, 15 Jan 2026
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- none
Who the study is looking for
- adult patients
- diagnose with chronic B-cell malignancies
- exposed to zanubrutinib or acalabrutinib
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.