Clinical trial NCT05819125: 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
Official title: Comparison of the Risk of Venous Thromboembolism and Bleeding Events in a Population of Obese Patients Receiving Higher-Dose or Extended-Duration Versus Conventional-Dose or Conventional-Duration of Prophylaxis With Enoxaparin
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Venous Thromboembolism
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2023-04-19
Enrollment: 21000
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: 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.

Brief 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.

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

Eligibility criteria: 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.

Primary outcomes:
measure: Change in the incidence of symptomatic 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: