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NCT Number: NCT06561243

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Chronic B-cell Malignancies BTK Inhibitors Cardiovascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Caen University Hospital, Department of Pharmacology

Caen, Normandy, France

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

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)

Primary outcomes

  1. 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

    ICD-10-CM code I48 will be used to identify AF during follow-up

Secondary outcomes

  1. Risk of incident atrial fibrillation in patients exposed to ibrutinib compared with those exposed to acalabrutinib in a matched cohort restricted to patients aged ≤75 and to patients aged >75

    Time frame: from the introduction of the BTK inhibitor and up to 120 months

    ICD-10-CM code I48 will be used to identify AF during follow-up

  2. Risk of incident atrial fibrillation in patients exposed to ibrutinib compared with those exposed to acalabrutinib in a matched cohort categorized according their baseline cardiovascular risk level for developing AF

    Time frame: from the introduction of the BTK inhibitor and up to 120 months

    ICD-10-CM code ill be used to identify AF during follow-up

  3. Risk of all-cause mortality 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

    death from any cause during follow-up

  4. Risk of incident intra-cerebral hemorrhage 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

    ICD-10-CM code ill be used to identify intra-cerebral hemorrhage during follow-up

  5. Risk of incident major bleeding 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

    ICD-10-CM code ill be used to identify major bleeding during follow-up

  6. Risk of incident hypertension 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

    ICD-10-CM code ill be used to identify hypertension during follow-up

  7. Risk of incident MACE (composite) 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

    ICD-10-CM code ill be used to identify MACE (composite of acute myocardial infraction, ischemic stroke or thromboembolism and heart failure) during follow-up

  8. Risk of incident ventricular tachycardia/ventricular fibrillation/cardiac arrest (composite) 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

    ICD-10-CM code ill be used to identify VT/VF/cardiac arrest (composite of ventricular tachycardia, ventricular fibrillation and cardiac arrest) during follow-up

Sponsors and collaborators

Lead sponsor

University Hospital, Caen

Other

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Aug 20, 2024
Registry last updated
Aug 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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