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

NCT05819112 | Terminated

• 2 other identifiers: PDE0093U1111-1288-8339
• Study Type: observational
• Target: 14,799
• Locations: 1 country
• Sites: 1

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.

Conditions

Venous Thromboembolism

Outcome Measures

Primary Outcomes (2)

• Change in the incidence of VTE, from index date to Day 90

  VTE 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.

• Change in the incidence of major bleeding, from index date to Day 90

  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 (2)

Conventional prophylaxis

Participants hospitalized for acute medical illness receiving conventional (i.e., once daily for 7 days) enoxaparin VTE prophylaxis

Extended prophylaxis

Participants hospitalized for acute medical illness receiving extended duration (i.e., once daily for 14, 21 or 28 days) enoxaparin VTE prophylaxis

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

Participants hospitalized for an acute medical illness receiving enoxaparin during hospitalization.

You may qualify if:

• 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

You may not qualify if:

• 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.

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 30, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share

Locations

US (1)