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The Incidence of Venous Thromboembolism in Atopic Dermatitis

NCT ID: NCT04969653

Last Updated: 2024-12-09

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

754745 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-06-21

Study Completion Date

2023-07-01

Brief Summary

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

Detailed Description

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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.

Conditions

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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

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

Exposure of venous thromboembolism

Intervention Type OTHER

Composite of pulmonary embolism and deep vein thrombosis

Controls

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

Exposure of venous thromboembolism

Intervention Type OTHER

Composite of pulmonary embolism and deep vein thrombosis

Interventions

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Exposure of venous thromboembolism

Composite of pulmonary embolism and deep vein thrombosis

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role collaborator

Momentum Data

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Andrew McGovern, MD

Role: STUDY_DIRECTOR

Momentum Data Ltd

Locations

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Momentum Data Ltd

London, , United Kingdom

Site Status

Countries

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United Kingdom

References

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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.

Reference Type RESULT
PMID: 37418627 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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P046

Identifier Type: -

Identifier Source: org_study_id