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

Sponsor

Sanofi (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05819125

Collaborator

(none)

21,000

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Venous Thromboembolism

Detailed Description

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

Study Design

Study Type:

Observational

Anticipated Enrollment :

21000 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

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

Anticipated Study Start Date :

Apr 1, 2023

Anticipated Primary Completion Date :

Apr 1, 2024

Anticipated Study Completion Date :

Apr 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Conventional prophylaxis Hospitalized obese participants with an acute medical condition or undergoing surgery, receiving conventional (i.e., 40 mg once daily for 7 days) enoxaparin VTE prophylaxis
High dose prophylaxis Hospitalized obese participants with an acute medical condition or undergoing surgery, receiving high dose enoxaparin for the conventional VTE prophylaxis duration
Extended duration prophylaxis Hospitalized obese participants with an acute medical condition or undergoing surgery, receiving the conventional enoxaparin dose for an extended VTE prophylaxis duration
High dose and extended duration prophylaxis Hospitalized obese participants with an acute medical condition or undergoing surgery, receiving high dose enoxaparin for an extended VTE prophylaxis duration

Outcome Measures

Primary Outcome Measures

Change in the incidence of symptomatic VTE, from index date to Day 90 [Retrospective data analysis from February, 2010 to September, 2021, with this endpoint evaluated up to 90 days after the individual participant's index date.]
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.
Change in the incidence of major bleeding, from index date to Day 90 [Retrospective data analysis from February, 2010 to September, 2021, with this endpoint evaluated up to 90 days after the individual participant's index date.]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Sanofi

Investigators

Study Director: Clinical Sciences & Operations, Sanofi

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Sanofi

ClinicalTrials.gov Identifier:

NCT05819125

Other Study ID Numbers:

CEF0112
U1111-1288-8394

First Posted:

Apr 19, 2023

Last Update Posted:

Apr 19, 2023

Last Verified:

Apr 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Thromboembolism

Venous Thromboembolism

Study Results

No Results Posted as of Apr 19, 2023