The Incidence of Venous Thromboembolism in Atopic Dermatitis

NCT04969653 | Completed Results

• 1 other identifier: P046
• Study Type: observational
• Target: 754,745
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Venous Thromboembolism; Atopic Dermatitis; Pulmonary Embolism; Deep Vein Thrombosis; Allergic Rhinitis; Allergy to House Dust Mite; Allergy to Animal Dander; Food Allergy; Cows Milk Allergy

Outcome Measures

Primary Outcomes (1)

• Number of Participants With 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 Outcomes (11)

• Number of Participants With Diagnosis of Pulmonary Embolism After the Start of Follow-up for Each Person

  10 years from index date

• Number of Participants With Diagnosis of Deep-vein Thrombosis After the Start of Follow-up for Each Person

  10 years from index date

• Number of Male Participants With Diagnosis of Risk of Venous Thromboembolism After the Start of Follow-up for Each Person

  10 years from index date

• Number of Female Participants With Diagnosis of Risk of Venous Thromboembolism After the Start of Follow-up for Each Person

  10 years from index date

• Number of Participants Aged 18-44 With Diagnosis of Venous Thromboembolism After the Start of Follow-up for Each Person

  10 years from index date

Study Arms (2)

Cases

All adults with an episode of active atopic dermatitis at any point between 1st Jan 2010 to 1st Jan 2015 will be included for analysis.

Other: Exposure of venous thromboembolism

Controls

Adults without atopic dermatitis or other skin conditions matched to cases by age, gender, and duration of practice registration.

Other: Exposure of venous thromboembolism

Interventions

Exposure of venous thromboembolism OTHER

Composite of pulmonary embolism and deep vein thrombosis

Cases; Controls

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study will use routinely collected and collated data from OPCRD to provide a broadly representative sample of the population of the UK.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Momentum Data: lead
• Pfizer: collaborator

Study Sites (1)

Momentum Data Ltd

London, WC1X 8QT, United Kingdom

Location

Related Publications (1)

• Warren RB, Basey V, Lynam A, Curtis C, Ardern-Jones MR. The risk of venous thromboembolism in atopic dermatitis: a matched cohort analysis in UK primary care. Br J Dermatol. 2023 Sep 15;189(4):427-436. doi: 10.1093/bjd/ljad212.

  PMID: 37418627 RESULT

MeSH Terms

Conditions

Venous Thromboembolism; Dermatitis, Atopic; Pulmonary Embolism; Venous Thrombosis; Rhinitis, Allergic; Dust Mite Allergy; Food Hypersensitivity; Milk Hypersensitivity

Condition Hierarchy (Ancestors)

Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Lung Diseases; Respiratory Tract Diseases; Embolism; Thrombosis; Rhinitis; Nose Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Rhinitis, Allergic, Perennial

Results Point of Contact

• Title: Dr Andrew McGovern
• Organization: Momentum Data Ltd

andy.mcgovern@momentumdata.co.uk

07531221970

Study Officials

• Andrew McGovern, MD

  Momentum Data Ltd

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

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

Study Record Dates

• First Submitted: July 1, 2021
• First Posted: July 21, 2021
• Study Start: June 21, 2021
• Primary Completion: March 31, 2023
• Study Completion: July 1, 2023
• Last Updated: December 9, 2024
• Results First Posted: December 9, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: The data will be available subject to approvals for two years after the study publication date
• Access Criteria: Data sharing is subject to ADEPT committee approval

Locations

GB (1)