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NCT05819125 · ClinicalTrials.gov registry record
Comparison of the Risk of Venous Thromboembolism (i.e., Blood Clots in the Veins) and Bleeding Events in a Population of Obese Patients Receiving Higher-Dose or Extended-Duration Versus Conventional-Dose or Conventional-Duration of Prophylaxis (i.e., Preventive Treatment) With Enoxaparin
A clinical trial, sponsored by Sanofi.
- Terminated
- Registry status
- 21,000
- Enrollment target
NCT05819125: Clinical Trial study, sponsored by Sanofi.
NCT05819125 is a clinical trial that was terminated before completion, run by Sanofi. The registered enrollment target is 21,000 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05819125 was terminated before completion, sponsored by Sanofi.
- TERMINATED
- Registry status
- 21,000 participants
- Enrollment target
Study Summary
In individuals with obesity, the optimal dosing and duration of venous thromboembolism (VTE) prophylaxis in settings representing acute medical illness or surgery is limited due to lack of randomized controlled trials (RCTs) focusing specifically on this population. Evidence suggests that in obese participants, both higher dosing and duration of VTE prophylaxis with Low Molecular Weight Heparins (LMWH) may be required to achieve a therapeutic effect similar to non-obese participants. This non-interventional study utilizes data already collected from a usual clinical practice setting in the Optum US clinical database, representing obese participants hospitalized with an acute medical condition or undergoing surgery receiving enoxaparin prophylaxis. Its aim is to compare the impact of the following enoxaparin prophylaxis strategies on the incidence of symptomatic VTE and major bleeding in the overall study population and prespecified subgroups: * High versus conventional dose * Extended versus conventional duration * Combined High-Dose and Extended-Duration versus Conventional-Dose and Conventional-Duration. The first date of enoxaparin prophylaxis will be the index date.
Primary Outcome
The VTE endpoint is intended to represent a new onset symptomatic VTE event. It will be identified in the proposed database by utilizing an algorithm based on the International Classification of Disease 10th and 9th revisions (ICD-10 and ICD-9) codes.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21,000 participants |
| Start Date | 2023-04-25 |
| Est. Completion | 2023-12-15 |
Why NCT05819125 stopped before completion
NCT05819125 is an observational study that tracks outcomes without assigning an intervention. Its 21,000 participants enrollment target places it among the larger protocols in the corpus.
The record links to 0 conditions, and to 0 interventions.
NCT05819125 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05819125 about?
NCT05819125 is a clinical study titled "Comparison of the Risk of Venous Thromboembolism (i.e., Blood Clots in the Veins) and Bleeding Events in a Population of Obese Patients Receiving Higher-Dose or Extended-Duration Versus Conventional-Dose or Conventional-Duration of Prophylaxis (i.e., Preventive Treatment) With Enoxaparin". In individuals with obesity, the optimal dosing and duration of venous thromboembolism (VTE) prophylaxis in settings representing acute medical illness or surgery is limited due to lack of randomized controlled trials (RCTs) focusing specifically on this population. Evidence suggests that in obese p...
What is the current status of trial NCT05819125?
This trial is currently terminated. The enrollment target is 21,000 participants. The study started on 2023-04-25. Estimated completion is 2023-12-15.
Who is sponsoring clinical trial NCT05819125?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
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