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NCT04394234 · ClinicalTrials.gov registry record
A Study of Severe Uterine Bleeding Following Exposure to Direct Oral Anticoagulants
A clinical trial, sponsored by Janssen Research & Development.
- Completed
- Registry status
- 961,985
- Enrollment target
NCT04394234: Completed study, sponsored by Janssen Research & Development.
NCT04394234 is a clinical trial that has completed, run by Janssen Research & Development. The registered enrollment target is 961,985 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04394234 has completed, sponsored by Janssen Research & Development.
- COMPLETED
- Registry status
- 961,985 participants
- Enrollment target
Study 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 \[TKR\]).
Primary Outcome
Number of participants with severe uterine bleed during two time-at-risk periods (on-treatment and all observed time post-index) will be reported.
Interventions
- DRUG Warfarin
- DRUG Direct oral anticoagulant (DOACs)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 961,985 participants |
| Start Date | 2020-05-15 |
| Est. Completion | 2020-06-01 |
What the finished NCT04394234 record still lists
NCT04394234 is an observational study that tracks outcomes without assigning an intervention. Its 961,985 participants enrollment target places it among the larger protocols in the corpus.
The record links to 0 conditions, and to 2 interventions - of which Warfarin is the first listed.
NCT04394234 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04394234 about?
NCT04394234 is a clinical study titled "A Study of Severe Uterine Bleeding Following Exposure to Direct Oral Anticoagulants". 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 ...
What is the current status of trial NCT04394234?
This trial is currently completed. The enrollment target is 961,985 participants. The study started on 2020-05-15. Estimated completion is 2020-06-01.
What interventions are being tested in trial NCT04394234?
The interventions under investigation include: Warfarin (DRUG), Direct oral anticoagulant (DOACs) (DRUG).
Who is sponsoring clinical trial NCT04394234?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
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