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

Venous Thromboembolism Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05819125
• Other study ID #: CEF0112
• Secondary ID: U1111-1288-8394
• Status: Active, not recruiting
• Start date: April 25, 2023
• Est. completion date: April 2024

Study information

• Verified date: May 2023
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 21000
• Est. completion date: April 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Thromboembolism
• Venous Thromboembolism

Locations

Country	Name	City	State
United States	Sanofi U.S.	Bridgewater	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the incidence of symptomatic VTE, from index date to Day 90	The VTE endpoint is intended to represent a new onset symptomatic VTE event. It will be identified in the proposed database by utilizing an algorithm based on the International Classification of Disease 10th and 9th revisions (ICD-10 and ICD-9) codes.	Retrospective data analysis from February, 2010 to September, 2021, with this endpoint evaluated up to 90 days after the individual participant's index date.
Primary	Change in the incidence of major bleeding, from index date to Day 90	The major bleeding event will be identified via an algorithm based on the International Classification of Disease-10th revision and 9th revision (ICD-10 and ICD-9) codes.	Retrospective data analysis from February, 2010 to September, 2021, with this endpoint evaluated up to 90 days after the individual participant's index date.