Ibrutinib and Acalabrutinib Use and Risk of Atrial Fibrillation in Patients With Chronic B-cell Malignancies
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 15,000
- 试验地点
- 1
- 主要终点
- Risk of incident atrial fibrillation in patients exposed to ibrutinib compared with those exposed to acalabrutinib in the whole matched cohort.
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- 未提供
研究组 & 干预措施
Ibrutinib
Adult patients with a chronic B-cell malignancy exposed to ibrutinib
干预措施: BTK inhibitor (Ibrutinib or Acalabrutinib) (Drug)
Acalabrutinib
Adult patients with a chronic B-cell malignancy exposed to acalabrutinib
干预措施: BTK inhibitor (Ibrutinib or Acalabrutinib) (Drug)
结局指标
主要结局
Risk of incident atrial fibrillation in patients exposed to ibrutinib compared with those exposed to acalabrutinib in the whole matched cohort.
时间窗: 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
次要结局
- Risk of all-cause mortality in patients exposed to ibrutinib compared with those exposed to acalabrutinib in the whole matched cohort(from the introduction of the BTK inhibitor and up to 120 months)
- Risk of incident intra-cerebral hemorrhage in patients exposed to ibrutinib compared with those exposed to acalabrutinib in the whole matched cohort(from the introduction of the BTK inhibitor and up to 120 months)
- Risk of incident major bleeding in patients exposed to ibrutinib compared with those exposed to acalabrutinib in the whole matched cohort(from the introduction of the BTK inhibitor and up to 120 months)
- 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(from the introduction of the BTK inhibitor and up to 120 months)
- Risk of incident MACE (composite) in patients exposed to ibrutinib compared with those exposed to acalabrutinib in the whole matched cohort(from the introduction of the BTK inhibitor and up to 120 months)
- 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(from the introduction of the BTK inhibitor and up to 120 months)
- 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(from the introduction of the BTK inhibitor and up to 120 months)
- Risk of incident hypertension in patients exposed to ibrutinib compared with those exposed to acalabrutinib in the whole matched cohort(from the introduction of the BTK inhibitor and up to 120 months)
研究者
Joachim ALEXANDRE
Professor
University Hospital, Caen