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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 is a clinical trial that has completed, run by Janssen Research & Development. The registered enrollment target is 961,985 participants.

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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 \[TKR\]).

Interventions

  • DRUG Warfarin
  • DRUG Direct oral anticoagulant (DOACs)

Trial Details

FieldValue
Enrollment Target 961,985 participants
Start Date 2020-05-15
Est. Completion 2020-06-01

Sponsor

Janssen Research & Development

593 total trials

What the Registry Record Tells You About NCT04394234

The ClinicalTrials.gov registry entry for NCT04394234 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 961,985 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Janssen Research & Development, which has 593 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Warfarin is the first listed.

NCT04394234 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.