Zanubrutinib and Acalabrutinib Use and Risk of Atrial Fibrillation in Patients With Chronic B-cell Malignancies
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Hospital, Caen
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
adult patients
diagnose with chronic B-cell malignancies
exposed to zanubrutinib or acalabrutinib
Disqualifiers
none
Trial population
adult patients - diagnose with chronic B-cell malignancies expose to zanubrutinib or acalabrutinib in the TrinetX database
Trial design
Design model
Cohort
Time perspective
Retrospective
Treatments tested in this trial
Zanubrutinib
DrugAdult patients with a chronic B-cell malignancy exposed to zanubrutinib
Acalabrutinib
DrugAdult patients with a chronic B-cell malignancy exposed to acalabrutinib
Treatment groups
15,000 Participants
are divided into 2 treatment groupsGroup A: Zanubrutinib1 intervention
Group B: Acalabrutinib1 intervention
Trial outcomes
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 yearsSecondary 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 years2
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 years3
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 years4
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 yearsLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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