NCT06561243 · ClinicalTrials.gov record · last posted 2024-08-21
Ibrutinib and Acalabrutinib Use and Risk of Atrial Fibrillation in Patients With Chronic B-cell Malignancies
StatusActive, Not Recruiting
PhaseNot specified
Started2024-07-25
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Record status
This record was last updated August 21, 2024 (before its estimated September 30, 2024 completion). Its status may not reflect the trial's current state.
from the ClinicalTrials.gov record
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.
Amendment record
1 amendment on the ClinicalTrials.gov record
This ClinicalTrials.gov record has been amended once since 2024-08-17. DataLookout shows field-level changes from the day a trial enters its daily monitoring; earlier amendments are counted here from the ClinicalTrials.gov version history.
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| NCT Number |
NCT06561243 |
| Lead Sponsor |
University Hospital, Caen
|
| Conditions |
Chronic B-cell Malignancies, BTK Inhibitors, Cardiovascular Diseases |
| Enrollment |
15,000 participants |
| Start Date |
2024-07-25 |
| Primary Completion |
2024-09-30 (estimated) |
| Study Completion |
2024-10-30 (estimated) |
| Updated on ClinicalTrials.gov |
2024-08-21 |