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

Sponsor
University Hospital, Caen
Study ID
NCT06561243
Status
Active Not Recruiting

Conditions

  • BTK Inhibitors
  • Cardiovascular Diseases
  • Chronic B-cell Malignancies

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • BTK inhibitor (Ibrutinib or Acalabrutinib) — DRUG
    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)

Study Details

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.

Key Dates

Start date
Jul 25, 2024
Status verified
Aug 2024
Primary completion
Sep 30, 2024
Completion
Oct 30, 2024

Study Design

Enrollment
15,000 participants (estimated)

Arms

  • Arm: Ibrutinib
    Adult patients with a chronic B-cell malignancy exposed to ibrutinib
  • Arm: Acalabrutinib
    Adult patients with a chronic B-cell malignancy exposed to acalabrutinib

Primary Outcome Measure

Risk of incident atrial fibrillation in patients exposed to ibrutinib compared with those exposed to acalabrutinib in the whole matched cohort. [ Time Frame: from the introduction of the BTK inhibitor and up to 120 months ]

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