Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06561243
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
None
First Post:
2024-07-24
Brief Title:
Ibrutinib and Acalabrutinib Use and Risk of Atrial Fibrillation in Patients With Chronic B-cell Malignancies
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Ibrutinib and Acalabrutinib Use and Risk of Atrial Fibrillation in Patients With Chronic B-cell Malignancies
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None