Sponsor's decision. Termination decision unrelated to safety profile.

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.

The study period will be from February 2010 to September 2021. Participants will be followed for 90 days.

Inclusion Criteria:

• Medical Patients: Hospitalization due to:

  • Heart failure
  • Ischemic stroke
  • Respiratory insufficiency
  • Infection
  • Inflammatory diseases
  • Active cancer

• Surgical Patents: Following surgery types:

  • Orthopedic
  • Thoracic
  • Abdominal/Pelvic

• Other inclusion criteria:

  • Initiation of enoxaparin prophylaxis (index date)
  • Age ≥ 40 years
  • Body Mass Index (BMI) ≥ 30

Exclusion Criteria:

• VTE or bleeding event during or 3 months prior to index date
• Surgery within 3 months prior to and up to two days following index date
• Atrial fibrillation
• Antiplatelet or anticoagulation therapy within [-32, -2] days before index date
• Chronic Kidney Disease (CKD) stages IV and V, or dialysis
• Pregnancy

The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.

Hospitalized obese participants with an acute medical condition or undergoing surgery receiving enoxaparin prophylaxis in the Optum Market Clarity database representing integrated information from electronic health records (EHRs) and claims.

Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org