A Study of Severe Uterine Bleeding Following Exposure to Direct Oral Anticoagulants
Completed
Conditions studied: Uterine Hemorrhage
In brief
The purpose of this study is assess the: (a) incidence of severe uterine bleeding (SUB) following exposure to individual direct oral anticoagulant (DOACs) (rivaroxaban, apixaban, dabigatran) and warfarin, (b) individual DOACs (rivaroxaban, apixaban, dabigatran) association with risk of SUB compared with warfarin, and (c) individual DOACs (rivaroxaban, apixaban, dabigatran) associated with risk of SUB compared with other individual DOACs - among women with prior diagnoses for DOAC and warfarin indications (non-valvular atrial fibrillation \[NVAF\], venous thromboembolism \[VTE\], total hip replacement \[THR\] or total knee replacement \[TKR\]).
Key facts
- Study ID
- NCT04394234
- Run by
- Janssen Research & Development, LLC
- People needed
- 961985
- Starts
- 2020-05-15
- Expected to finish
- 2020-06-01
- Last updated by the study team
- 2025-04-27
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Non-valvular atrial fibrillation (NVAF) diagnosis any time prior and no Venous thromboembolism (VTE) (Deep vein thrombosis [DVT] or Pulmonary embolism [PE]) in the past 183 days and no knee or hip replacement surgery in the past 35 days
- VTE (DVT or PE) in the past 183 days and no NVAF diagnosis any time prior and no knee or hip replacement surgery in the past 35 days
- Total hip replacement (THR) or Total knee replacement (TKR) in the past 35 days and no non-valvular atrial fibrillation any time prior and no venous thromboembolism (deep vein thrombosis of pulmonary embolism) in the past 183 days
You may not qualify if…
- Participants were excluded for edoxaban exposure, exposure to other exposures of interest (example: Direct oral anticoagulant [DOACs] for warfarin exposure cohort), hysterectomy, vaginal bleed, and medical, surgical, or transfusion management for vaginal bleeding any time prior to the index exposure
Where it is running
- Janssen R&D — Titusville, New Jersey, United States
Full record on ClinicalTrials.gov
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