The Incidence of Venous Thromboembolism in Atopic Dermatitis

Atopic Dermatitis Clinical Trial

Official title:

The Incidence of Venous Thromboembolism in Atopic Dermatitis: A Matched Cohort Analysis in UK Primary Care

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04969653
• Other study ID #: P046
• Status: Completed
• Start date: June 21, 2021
• Est. completion date: July 1, 2023

Study information

• Verified date: August 2023
• Source: Momentum Data
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study aims to investigate the incidence of venous thromboembolism in people who are diagnosed with atopic dermatitis.

Description:

The aim of this study is to examine whether venous thromboembolism is higher in people with atopic dermatitis compared and those without and to explore the risk in particular subgroups of people with AD such as those with higher body mass index or using oestrogen containing contraceptives. Such insights will be valuable for clinicians in advising patients with atopic dermatitis regarding venous thromboembolism prevention and detection and when selecting atopic dermatitis treatments.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 754745
• Est. completion date: July 1, 2023
• Est. primary completion date: March 31, 2023
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• All eligible adult people (aged = 18) registered with GP practices contributing data to OPCRD between January 1, 2010 and January 1, 2020, were eligible for inclusion in the study.

Exclusion Criteria:

• People with less than 5 years potential follow up. People with atopic dermatitis that was not active atopic dermatitis during the study period. People without atopic dermatitis but diagnosed with other skin conditions.

Related Conditions & MeSH terms

• Allergic Rhinitis
• Allergy to House Dust Mite
• Atopic Dermatitis
• Deep Vein Thrombosis
• Dermatitis
• Dermatitis, Atopic
• Dust Mite Allergy
• Eczema
• Embolism
• Food Allergy
• Food Hypersensitivity
• Hypersensitivity
• Milk Hypersensitivity
• Pulmonary Embolism
• Thromboembolism
• Thrombosis
• Venous Thromboembolism
• Venous Thrombosis

Intervention

Other:
• Exposure of venous thromboembolism
Composite of pulmonary embolism and deep vein thrombosis

Locations

Country	Name	City	State
United Kingdom	Momentum Data Ltd	London

Sponsors (2)

Lead Sponsor	Collaborator
Momentum Data	Pfizer

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnosis of venous thromboembolism after the start of follow-up for each person.	To describe the risk of venous thromboembolism (composite of pulmonary embolism and deep vein thrombosis) in people with active AD compared to a matched control population.	10 years from index date
Secondary	Diagnosis of pulmonary embolism and deep vein thrombosis individually after the start of follow-up for each person	To describe the risk of pulmonary embolism and deep vein thrombosis individually in people with active AD compared to a matched control population.	10 years from index date
Secondary	Demographic sub-group analysis of risk of venous thromboembolism	To explore potential heterogeneity in the risk of venous thromboembolism across subgroups of people with atopic dermatitis: by gender, age groups (18-45, 45-65, 65+), obesity, baseline use of oestrogen containing contraceptives in females, atopic dermatitis severity and history of allergic conditions.	10 years from index date
Secondary	Allergic condition sub-group analysis of risk of venous thromboembolism	To explore risk of VTE stratified by the presence, or absence of allergic conditions at baseline. Allergic conditions will comprise common allergies; allergic rhinitis, allergy to dust mites or animal dander, and food allergies e.g., nut, fruit, shellfish, eggs and cows' milk allergies. Medication and other allergies will not be included.	10 years from index date