Menu
Not yet recruiting NCT07283965

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

— Observational Chronic B-cell Malignancies BTK Inhibitors Cardiovascular Diseases

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Zanubrutinib, Acalabrutinib.
Who it may be relevant to
Registry conditions: Chronic B-cell Malignancies, BTK Inhibitors, Cardiovascular Diseases. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • 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

Primary outcome measures

  • 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 outcome measures (6)
  • 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]
  • 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]
  • 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]
  • 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]
  • 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]
  • 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]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

  • none

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07283965 · Pharmaco111525

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗