Status:
COMPLETED
A Study of Severe Uterine Bleeding Following Exposure to Direct Oral Anticoagulants
Lead Sponsor:
Janssen Research & Development, LLC
Conditions:
Uterine Hemorrhage
Eligibility:
FEMALE
18+ years
Brief Summary
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 warfa...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
May 15 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 1 2020
Estimated Enrollment :
961985 Patients enrolled
Trial Details
Trial ID
NCT04394234
Start Date
May 15 2020
End Date
June 1 2020
Last Update
April 27 2025
Active Locations (1)
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1
Janssen R&D
Titusville, New Jersey, United States, 08560