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NCT04818151 · ClinicalTrials.gov registry record
Anticoagulation Strategies for Acute Venous Thromboembolism in Patients With End-Stage Renal Disease Using USRDS Data
A clinical trial, sponsored by Johns Hopkins University.
- Completed
- Registry status
- 14,914
- Enrollment target
NCT04818151: Completed study, sponsored by Johns Hopkins University.
NCT04818151 is a clinical trial that has completed, run by Johns Hopkins University. The registered enrollment target is 14,914 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04818151 has completed, sponsored by Johns Hopkins University.
- COMPLETED
- Registry status
- 14,914 participants
- Enrollment target
Study Summary
Patients with end stage renal disease (ESRD) are at significantly increased risk of thrombosis and bleeding relative to those with normal renal function which makes anticoagulation particularly challenging. Further, ESRD patients undergoing initiation of anticoagulation for acute VTE are often kept in the hospital for heparin "bridging" which may lead to a protracted length-of-stay (LOS) and may place patients at risk for hospital-associated complications. The advent of direct oral anticoagulants (DOACs) has offered physicians choices in the management of venous thromboembolism (VTE). However, evidence suggests that rivaroxaban and dabigatran are associated with a higher risk of bleeding in ESRD patients. In contrast, research suggests that apixaban may be safer in patients with ESRD, and recent evidence suggests lower bleeding rates in ESRD patients treated for atrial fibrillation with apixaban compared to those treated with warfarin. However, to date, no large national cohort studies have examined the safety, effectiveness, and healthcare utilization of apixaban in patients with ESRD who have acute VTE. The investigators propose to use the Standard Analytic Files from the United States Renal Data System (USRDS) for years 2014 through 2018 to evaluate the safety, effectiveness, and healthcare utilization of ESRD patients initiated on apixaban compared to those initiated on warfarin (following heparin) to treat acute VTE.
Primary Outcome
Number of bleeding occurrences.
Interventions
- DRUG Apixaban
- DRUG Warfarin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14,914 participants |
| Start Date | 2021-01-01 |
| Est. Completion | 2021-06-30 |
What the finished NCT04818151 record still lists
NCT04818151 is an observational study that tracks outcomes without assigning an intervention. Its 14,914 participants enrollment target places it among the larger protocols in the corpus.
The record links to 0 conditions, and to 2 interventions - of which Apixaban is the first listed.
NCT04818151 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04818151 about?
NCT04818151 is a clinical study titled "Anticoagulation Strategies for Acute Venous Thromboembolism in Patients With End-Stage Renal Disease Using USRDS Data". Patients with end stage renal disease (ESRD) are at significantly increased risk of thrombosis and bleeding relative to those with normal renal function which makes anticoagulation particularly challenging. Further, ESRD patients undergoing initiation of anticoagulation for acute VTE are often kept ...
What is the current status of trial NCT04818151?
This trial is currently completed. The enrollment target is 14,914 participants. The study started on 2021-01-01. Estimated completion is 2021-06-30.
What interventions are being tested in trial NCT04818151?
The interventions under investigation include: Apixaban (DRUG), Warfarin (DRUG).
Who is sponsoring clinical trial NCT04818151?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
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