Clinical trial NCT04394234: A Study of Severe Uterine Bleeding Following Exposure to Direct Oral Anticoagulants
Official title: Comparative Risk Assessment of Severe Uterine Bleeding Following Exposure to Direct Oral Anticoagulants: A Network Study Across 4 US Observational Databases
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Uterine Hemorrhage
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2020-05-19
Enrollment: 961985
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population will include adult women aged 18 years and older who are newly exposed to DOACs or warfarin with greater than or equal to (\>=) 183 days of prior continuous database observation between 19-Oct-2010 and 31-Dec-2018 will be assessed for severe uterine bleeding.

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 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 \[TKR\]).


Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Number of Participants with Severe Uterine Bleed
timeFrame: From 19-Oct-2010 to 31-Dec-2018
Secondary outcomes:
Other outcomes:
Locations:
city: Titusville
country: United States
facility: Janssen R&D
state: New Jersey
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References:
citation: Weaver J, Shoaibi A, Truong HQ, Larbi L, Wu S, Wildgoose P, Rao G, Freedman A, Wang L, Yuan Z, Barnathan E. Comparative Risk Assessment of Severe Uterine Bleeding Following Exposure to Direct Oral Anticoagulants: A Network Study Across Four Observational Databases in the USA. Drug Saf. 2021 Apr;44(4):479-497. doi: 10.1007/s40264-021-01060-4. Epub 2021 Mar 2.