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NCT Number: NCT07283965

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

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.

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Key information

Conditions

Chronic B-cell Malignancies BTK Inhibitors Cardiovascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • adult patients
  • diagnose with chronic B-cell malignancies
  • exposed to zanubrutinib or acalabrutinib

Exclusion criteria

  • none

Treatment and study plan

Zanubrutinib

Drug

Adult patients with a chronic B-cell malignancy exposed to zanubrutinib

Acalabrutinib

Drug

Adult patients with a chronic B-cell malignancy exposed to acalabrutinib

Primary outcomes

  1. Risk of incident atrial fibrillation in patients exposed to zanubrutinib compared with those exposed to acalabrutinib in the matched cohort.

    Time frame: from the introduction of the BTK inhibitor and up to 5 years

Secondary outcomes

  1. Risk of all-cause mortality in patients exposed to zanubrutinib compared with those exposed to acalabrutinib in thematched cohort

    Time frame: from the introduction of the BTK inhibitor and up to 5 years

  2. Risk of incident intra-cerebral hemorrhage in patients exposed to zanubrutinib compared with those exposed to acalabrutinib in the matched cohort

    Time frame: from the introduction of the BTK inhibitor and up to 5 years

  3. Risk of incident major bleeding in patients exposed to zanubrutinib compared with those exposed to acalabrutinib in the matched cohort

    Time frame: from the introduction of the BTK inhibitor and up to 5 years

  4. Risk of incident hypertension in patients exposed to zanubrutinib compared with those exposed to acalabrutinib in the matched cohort

    Time frame: from the introduction of the BTK inhibitor and up to 5 years

  5. Risk of incident MACE (composite) in patients exposed to zanubrutinib compared with those exposed to acalabrutinib in the matched cohort

    Time frame: from the introduction of the BTK inhibitor and up to 5 years

  6. Risk of incident ventricular tachycardia/ventricular fibrillation/cardiac arrest (composite) in patients exposed to zanubrutinib compared with those exposed to acalabrutinib in the matched cohort

    Time frame: from the introduction of the BTK inhibitor and up to 5 months

Study contacts

Contact information is provided by the study sponsor or research team.

Joachim Alexandre, MD, PhD

CONTACT

[email protected]

+33231064670

Sponsors and collaborators

Lead sponsor

University Hospital, Caen

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 16, 2025
Registry last updated
Dec 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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