A Comparison of Extended Versus Conventional Duration of Enoxaparin Prophylaxis for VTE and Bleeding Event Risk in a Population With Acute Medical Illness

Status: Terminated
Location: See location...
Study Type: Observational
SUMMARY

Venous Thromboembolism (VTE), including deep vein thrombosis (DVT) and pulmonary embolism (PE), is associated with an increase in risk of mortality and long-term disability and is a major contributor to global disease burden. Participants hospitalized with an acute medical illness are at increased risk of VTE. This study a non-interventional study which analyzes data already collected in the Optum US clinical database. Its aim is to compare conventional versus extended duration prophylaxis with enoxaparin on the incidence of VTE and bleeding events in participants hospitalized for acute medical illness. The first date of enoxaparin treatment will be the index date.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 40
Healthy Volunteers: f
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• Hospitalization for the following acute conditions:

‣ Infection

⁃ Respiratory insufficiency

⁃ Inflammatory condition

⁃ Cancer

⁃ Heart failure

⁃ Ischemic stroke

• Initiation of enoxaparin prophylaxis during hospitalization (index date)

• Age ≥40 years

Locations
United States
New Jersey
Sanofi U.S.
Bridgewater
Time Frame
Start Date: 2023-04-25
Completion Date: 2023-12-15
Participants
Target number of participants: 14799
Treatments
Conventional prophylaxis
Participants hospitalized for acute medical illness receiving conventional (i.e., once daily for 7 days) enoxaparin VTE prophylaxis
Extended prophylaxis
Participants hospitalized for acute medical illness receiving extended duration (i.e., once daily for 14, 21 or 28 days) enoxaparin VTE prophylaxis
Sponsors
Leads: Sanofi

This content was sourced from clinicaltrials.gov