A Study of Severe Uterine Bleeding Following Exposure to Direct Oral Anticoagulants

NCT04394234 | Completed FDA Drug

• 2 other identifiers: CR108824PCSCVM002566
• Study Type: observational
• Target: 961,985
• Locations: 1 country
• Sites: 1

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 \[TKR\]).

Conditions

Uterine Hemorrhage

Outcome Measures

Primary Outcomes (1)

• Number of Participants with Severe Uterine Bleed

  Number of participants with severe uterine bleed during two time-at-risk periods (on-treatment and all observed time post-index) will be reported.

  From 19-Oct-2010 to 31-Dec-2018

Study Arms (2)

Treatment Group

Participants data who are new users of rivaroxaban, apixaban and dabigatran with prior Non-valvular atrial fibrillation/Venous thromboembolism/Total hip replacement (NVAF/VTE/THR) or Total knee replacement (TKR) in a nationally representative population of insured participants in the United States (US) will be compared pairwise.

Drug: Direct oral anticoagulant (DOACs)

Comparator Group

Participants data who are new users of warfarin, apixaban, and dabigatran with prior NVAF/VTE/THR or TKR in a nationally representative population of insured participants in the US will be compared pairwise.

Drug: Direct oral anticoagulant (DOACs); Drug: Warfarin

Interventions

Direct oral anticoagulant (DOACs) DRUG

Data of participants newly exposed to individual DOACs that is rivaroxaban, apixaban, dabigatran from 19-Oct-2010 to 31-Dec-2018 will be assessed. No study drug treatment will be administered as part of this observational study.

Comparator Group; Treatment Group

Warfarin DRUG

Data of participants newly exposed to warfarin from 19-Oct-2010 to 31-Dec-2018 will be assessed. No study drug treatment will be administered as part of this observational study.

Comparator Group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (1)

Janssen R&D

Titusville, New Jersey, 08560, United States

Location

Related Publications (1)

• 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.

  PMID: 33651368 DERIVED

MeSH Terms

Conditions

Uterine Hemorrhage

Interventions

N(4)-oleylcytosine arabinoside; Warfarin

Condition Hierarchy (Ancestors)

Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

4-Hydroxycoumarins; Coumarins; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2020
• First Posted: May 19, 2020
• Study Start: May 15, 2020
• Primary Completion: June 1, 2020
• Study Completion: June 1, 2020
• Last Updated: April 27, 2025

Record last verified: 2025-04

Locations

US (1)