Clinical trial NCT05819112: 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
Official title: A Comparison of Extended Versus Conventional Duration of Enoxaparin Prophylaxis for VTE and Bleeding Event Risk in a Population With Acute Medical Illness
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Venous Thromboembolism
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2023-04-19
Enrollment: 14799
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants hospitalized for an acute medical illness receiving enoxaparin during hospitalization.

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in the incidence of VTE, from index date to Day 90
timeFrame: Retrospective data analysis from February, 2010 to September, 2021, with this endpoint evaluated up to 90 days after the individual participant's index date.
measure: Change in the incidence of major bleeding, from index date to Day 90
timeFrame: Retrospective data analysis from February, 2010 to September, 2021, with this endpoint evaluated up to 90 days after the individual participant's index date.
Secondary outcomes:
Other outcomes:
Locations:
city: Bridgewater
country: United States
facility: Sanofi U.S.
state: New Jersey
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: