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

Trial Title: Ibrutinib and Acalabrutinib Use and Risk of Atrial Fibrillation in Patients With Chronic B-cell Malignancies

NCT ID: NCT06561243

Condition: Chronic B-cell Malignancies
BTK Inhibitors
Cardiovascular Diseases

Conditions: Official terms:
Neoplasms
Atrial Fibrillation
Cardiovascular Diseases
Acalabrutinib
Ibrutinib

Study type: Observational

Overall status: Active, not recruiting

Study design:

Time perspective: Retrospective

Intervention:

Intervention type: Drug
Intervention name: BTK inhibitor (Ibrutinib or Acalabrutinib)
Description: Adult patients with a chronic B-cell malignancy included in this study will be separate into 2 groups according to the BTK inhibitor (ibrutinib and acalabrutinib)
Arm group label: Acalabrutinib
Arm group label: Ibrutinib

Summary: Background. Ibrutinib 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 ibrutinib 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 ibrutinib or acalabrutinib. Patients will be divided into 2 groups based on ibrutinib or acalabrutinib exposure. After propensity score matching (PSM), hazard ratios (HRs) and their associated 95% confidence intervals (CIs) will be used to compare AF risk during follow-up between the matched 2 groups.

Criteria for eligibility:

Study pop:
adult patients - diagnose with chronic B-cell malignancies expose to ibrutinib or acalabrutinib in the TrinetX database

Sampling method: Non-Probability Sample
Criteria:
Inclusion Criteria: - adult patients - diagnose with chronic B-cell malignancies using ICD-10-CM codes C91 (lymphoid leukemia), C88.0 (Waldenström macroglobulinemia), C83.1 (mantle cell lymphoma), C81-C96 (malignant neoplasms of lymphoid, hematopoietic and related tissue) or C95 (leukemia of unspecified cell type) - expose to ibrutinib or acalabrutinib determined by the Anatomical Therapeutic Chemical codes Exclusion Criteria: -

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Locations:

Facility:
Name: Caen University Hospital, Department of Pharmacology

Address:
City: Caen
Country: France

Start date: July 25, 2024

Completion date: October 30, 2024

Lead sponsor:
Agency: University Hospital, Caen
Agency class: Other

Source: University Hospital, Caen

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06561243