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NCT04969653

The Incidence of Venous Thromboembolism in Atopic Dermatitis

Completed Results posted Last updated 9 December 2024
What this trial tests

trial testing Exposure of venous thromboembolism in Venous Thromboembolism in 754,745 participants. Completed in 1 July 2023.

Timeline
21 June 2021
Primary endpoint
31 March 2023
1 July 2023

Quick facts

Lead sponsorMomentum Data
StatusCompleted
Study typeOBSERVATIONAL
Enrollment754,745
Start date21 June 2021
Primary completion31 March 2023
Estimated completion1 July 2023
Sites1 location across United Kingdom

Drugs / interventions tested

Conditions studied

Sponsor

Momentum Data

Who can join

18 and older, any sex, with Venous Thromboembolism or Atopic Dermatitis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With Diagnosis of Venous Thromboembolism After the Start of Follow-up for Each Person. Primary · 10 years from index date

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.

GroupValue95% CI
Cases2576
Controls7563
Number of Participants With Diagnosis of Pulmonary Embolism After the Start of Follow-up for Each Person Secondary · 10 years from index date

To describe the risk of pulmonary embolism in people with active AD compared to a matched control population.

GroupValue95% CI
Cases797
Controls2942
Number of Participants With Diagnosis of Deep-vein Thrombosis After the Start of Follow-up for Each Person Secondary · 10 years from index date

To describe the risk of deep-vein thrombosis in people with active AD compared to a matched control population.

GroupValue95% CI
Cases1887
Controls4934
Number of Male Participants With Diagnosis of Risk of Venous Thromboembolism After the Start of Follow-up for Each Person Secondary · 10 years from index date

To explore the risk of VTE stratified by the male sex at the baseline in people with active AD compared to a matched control population.

GroupValue95% CI
Cases1070
Controls3170
Number of Female Participants With Diagnosis of Risk of Venous Thromboembolism After the Start of Follow-up for Each Person Secondary · 10 years from index date

To explore the risk of VTE stratified by the female sex at the baseline in people with active AD compared to a matched control population.

GroupValue95% CI
Cases1506
Controls4393
Number of Participants Aged 18-44 With Diagnosis of Venous Thromboembolism After the Start of Follow-up for Each Person Secondary · 10 years from index date

To explore the risk of VTE stratified by those aged 18-44 at the baseline in people with active AD compared to a matched control population.

GroupValue95% CI
Cases503
Controls1592
Number of Participants Aged 45-64 With Diagnosis of Venous Thromboembolism After the Start of Follow-up for Each Person Secondary · 10 years from index date

To explore the risk of VTE stratified by those aged 45-64 at the baseline in people with active AD compared to a matched control population.

GroupValue95% CI
Cases639
Controls1858
Number of Participants Aged ≥65 With Diagnosis of Venous Thromboembolism After the Start of Follow-up for Each Person Secondary · 10 years from index date

To explore the risk of VTE stratified by those aged ≥65 at the baseline in people with active AD compared to a matched control population.

GroupValue95% CI
Cases1434
Controls4113
Number of Participants BMI <30 With Diagnosis of Venous Thromboembolism After the Start of Follow-up for Each Person Secondary · 10 years from index date

To explore the risk of VTE stratified by those with a BMI \<30 at the baseline with active AD compared to a matched control population. Patients with active AD and missing BMI are excluded along with their related matched cases. Patients with active AD and no matched controls with BMI recorded are also excluded.

GroupValue95% CI
Cases1398
Controls3188
Number of Participants BMI ≥30 With Diagnosis of Venous Thromboembolism After the Start of Follow-up for Each Person Secondary · 10 years from index date

To explore the risk of VTE stratified by those with a BMI ≥30 at the baseline in people with active AD compared to a matched control population. Patients with active AD and missing BMI are excluded along with their related matched cases. Patients with active AD and no matched controls with BMI recorded are also excluded.

GroupValue95% CI
Cases685
Controls760
Number of Female Participants Aged 18-44 Using Oestrogen Contraceptive With Diagnosis of Venous Thromboembolism After the Start of Follow-up for Each Person Secondary · 10 years from index date

To explore the risk of VTE stratified by oestrogen contraceptive use in females aged 18-44 years at the baseline in people with active AD compared to a matched control population.

GroupValue95% CI
Cases31
Controls34
Number of Participants Having History of an Allergic Condition With Diagnosis of Venous Thromboembolism After the Start of Follow-up for Each Person Secondary · 10 years from index date

To explore risk of VTE stratified by the presence, or absence of allergic conditions at baseline in people with active AD compared to a matched control population.. 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.

GroupValue95% CI
Cases193
Controls203

Sponsor's own description

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

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Venous Thromboembolism

Currently open trials in the same condition.

Other Momentum Data trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04969653.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing