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

Venous Thromboembolism Clinical Trial

Official title:

A Comparison of Extended Versus Conventional Duration of Enoxaparin Prophylaxis for VTE and Bleeding Event Risk in a Population With Acute Medical Illness

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05819112
• Other study ID #: PDE0093
• Secondary ID: U1111-1288-8339
• 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

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.

Description:

The study population will be developed from the Optum Clinical database in the United States, representing routine clinical practice. Study population will comprise of participants hospitalized for an acute medical illness receiving enoxaparin during hospitalization. The first date of enoxaparin treatment will be the index date. 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: 14799
• 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:

• 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

Exclusion Criteria:

• 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.

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 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.
Primary	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.