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

NCT05819125 | Terminated

• 2 other identifiers: CEF0112U1111-1288-8394
• Study Type: observational
• Target: 21,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Venous Thromboembolism

Outcome Measures

Primary Outcomes (2)

• 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.

• 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.

Study Arms (4)

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

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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
• Initiation of enoxaparin prophylaxis (index date)
• Age ≥ 40 years
• Body Mass Index (BMI) ≥ 30

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (1)

Sanofi U.S.

Bridgewater, New Jersey, 08807, United States

Location

MeSH Terms

Conditions

Venous Thromboembolism

Condition Hierarchy (Ancestors)

Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2023
• First Posted: April 19, 2023
• Study Start: April 25, 2023
• Primary Completion: December 15, 2023
• Study Completion: December 15, 2023
• Last Updated: October 29, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share

Locations

US (1)