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NCT04979780 · ClinicalTrials.gov registry record
Observational Studies in Cancer Associated Thrombosis for Rivaroxaban - United States Cohort
A clinical trial, sponsored by Bayer.
- Completed
- Registry status
- 3,708
- Enrollment target
NCT04979780 is a clinical trial that has completed, run by Bayer. The registered enrollment target is 3,708 participants.
The verdict
NCT04979780 has completed, sponsored by Bayer.
- COMPLETED
- Registry status
- 3,708 participants
- Enrollment target
Study Summary
Patients with active cancer are \~5-fold more likely to develop a venous thromboembolism (VTE) than those without. When VTE occurs, cancer patients carry an up to a 3-fold higher rate of thrombosis recurrence and \~twice the risk of bleeding during anticoagulation. Therefore, it is critical to utilize anticoagulants that optimize efficacy while minimizing bleeding risk when treating cancer-associated thrombosis (CAT). Guidelines list direct-acting oral anticoagulants (DOACs) as an alternative to low molecular-weight heparin (LMWH) for treatment of CAT. The strength-of-recommendation for DOACs is based on data from multiple randomized controlled trials (RCTs) comparing them to LMWHs to treat CAT, with results suggesting DOACs may reduce thrombosis risk but with potentially more frequent bleeding (particularly in those with certain gastrointestinal and genitourinary cancers). Observational studies evaluating DOACs for CAT treatment have been published, but these studies have been either single-arm, evaluated cancer subtypes not recommended for DOAC treatment, were of limited sample size and/or employed heterogeneous definitions of active cancer. We seek to evaluate the effectiveness and safety of rivaroxaban versus LMWH for CAT treatment in active cancer patients using a large de-identified electronic health record database. Retrospective cohort analysis using US Optum® De-Identified EHR data. We will use Optum EHR (electronic health records) data from November January 1, 2012 through latest available data (currently September 2020).
Interventions
- DRUG Rivaroxaban (Xarelto, BAY59-7939)
- DRUG Low molecular weight heparin (LMWH)
- DRUG Direct Oral Anticoagulants (DOAC)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3,708 participants |
| Start Date | 2021-07-20 |
| Est. Completion | 2022-03-31 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04979780
The ClinicalTrials.gov registry entry for NCT04979780 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 3,708 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bayer, which has 591 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Rivaroxaban (Xarelto, BAY59-7939) is the first listed.
NCT04979780 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04979780 about?
NCT04979780 is a clinical study titled "Observational Studies in Cancer Associated Thrombosis for Rivaroxaban - United States Cohort". Patients with active cancer are \~5-fold more likely to develop a venous thromboembolism (VTE) than those without. When VTE occurs, cancer patients carry an up to a 3-fold higher rate of thrombosis recurrence and \~twice the risk of bleeding during anticoagulation. Therefore, it is critical to utili...
What is the current status of trial NCT04979780?
This trial is currently completed. The enrollment target is 3,708 participants. The study started on 2021-07-20. Estimated completion is 2022-03-31.
What interventions are being tested in trial NCT04979780?
The interventions under investigation include: Rivaroxaban (Xarelto, BAY59-7939) (DRUG), Low molecular weight heparin (LMWH) (DRUG), Direct Oral Anticoagulants (DOAC) (DRUG).
Who is sponsoring clinical trial NCT04979780?
This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.
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