A Comparison of Extended Versus Conventional Duration of Enoxaparin Prophylaxis (i.e., Preventive Treatment) for Venous Thromboembolism (VTE, i.e., Blood Clots in the Veins) and Bleeding Event Risk in a Population With Acute Medical Illness

Sanofi

Status: Terminated

Conditions: Venous Thromboembolism

Study type: Observational

Funder types: Industry

Identifiers

NCT05819112

PDE0093

U1111-1288-8339 (Registry Identifier)

Details and patient eligibility

About

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.

Full description

The study population will be developed from the Optum Clinical database in the United States, representing routine clinical practice. Study population will comprise of participants hospitalized for an acute medical illness receiving enoxaparin during hospitalization. The first date of enoxaparin treatment will be the index date. The study period will be from February 2010 to September 2021. Participants will be followed for 90 days.

Enrollment: 14,799 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• Symptomatic VTE or major bleeding event 90-days prior to index date
• Major surgery within (+1,-90) days from index date
• Ongoing anticoagulation therapy (medication supply within [-2,-32] days from index date)
• Atrial fibrillation
• Chronic kidney disease (CKD) stages IV and V, or dialysis

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

Trial design

14,799 participants in 2 patient groups

Conventional prophylaxis

Description:

Participants hospitalized for acute medical illness receiving conventional (i.e., once daily for 7 days) enoxaparin VTE prophylaxis

Extended prophylaxis

Description:

Participants hospitalized for acute medical illness receiving extended duration (i.e., once daily for 14, 21 or 28 days) enoxaparin VTE prophylaxis