Venous ThromboembolismNCT04969653
The Incidence of Venous Thromboembolism in Atopic Dermatitis
An observational study of Venous Thromboembolism and Atopic Dermatitis, run by Momentum Data at 1 site in United Kingdom.
Trial summary
This study aims to investigate the incidence of venous thromboembolism in people who are diagnosed with atopic dermatitis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Thromboembolism, Atopic Dermatitis, Pulmonary Embolism
- What is being tested?
- Exposure of venous thromboembolism
- How many people
- 754,745 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 21 Jun 2021to 1 Jul 2023
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Incidence of Venous Thromboembolism in Atopic Dermatitis: A Matched Cohort Analysis in UK Primary Care
This study aims to investigate the incidence of venous thromboembolism in people who are diagnosed with atopic dermatitis.
Read the detailed 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.
- Conditions
- Venous Thromboembolism, Atopic Dermatitis, Pulmonary Embolism, Deep Vein Thrombosis, Allergic Rhinitis, Allergy to House Dust Mite
- Being tested
- Exposure of venous thromboembolism
- Medical subject headings
- Venous Thromboembolism, Dermatitis, Atopic, Pulmonary Embolism, Venous Thrombosis, Rhinitis, Allergic, Dust Mite Allergy, Food Hypersensitivity, Milk Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exposure of venous thromboembolismOther
Composite of pulmonary embolism and deep vein thrombosis
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Exposure of venous thromboembolism |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
To describe the risk of pulmonary embolism in people with active AD compared to a matched control population.
Measured: 10 years from index date
Number of Participants With Diagnosis of Deep-vein Thrombosis After the Start of Follow-up for Each Person
To describe the risk of deep-vein thrombosis in people with active AD compared to a matched control population.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 10 years from index date
Number of Participants Aged 45-64 With Diagnosis of Venous Thromboembolism After the Start of Follow-up for Each Person
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.
Measured: 10 years from index date
Number of Participants Aged ≥65 With Diagnosis of Venous Thromboembolism After the Start of Follow-up for Each Person
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.
Measured: 10 years from index date
Number of Participants BMI <30 With Diagnosis of Venous Thromboembolism After the Start of Follow-up for Each Person
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.
Measured: 10 years from index date
Number of Participants BMI ≥30 With Diagnosis of Venous Thromboembolism After the Start of Follow-up for Each Person
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.
Measured: 10 years from index date
Number of Female Participants Aged 18-44 Using Oestrogen Contraceptive With Diagnosis of Venous Thromboembolism After the Start of Follow-up for Each Person
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.
Measured: 10 years from index date
Number of Participants Having History of an Allergic Condition With Diagnosis of Venous Thromboembolism After the Start of Follow-up for Each Person
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.
Measured: 10 years from index date
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2021
- Study start21 Jun 2021
- Primary completion31 Mar 2023
- Study completion1 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Venous ThromboembolismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 754,745 participants (actual)
Sponsor and investigators
- Lead sponsor
- Momentum Data
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Pfizer
- Responsible party
- Sponsor
- Investigators
- Andrew McGovern, MD, Study director, Momentum Data Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04969653
- Sponsor's protocol ID
- P046
- Status last verified
- Oct 2024
- First submitted
- 1 Jul 2021
- Last updated
- 9 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: OPCRD data can be accessed by bone fide researchers for specific research projects, subject to approval by Anonymised Data Ethics \& Protocol Transparency (ADEPT) Committee. The data utilised for this study cannot be made available without such approval.
Publications
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.
PubMed 37418627
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Incidence of Venous Thromboembolism in Atopic Dermatitis: A Matched Cohort Analysis in UK Primary Care
- ClinicalTrials.gov ID
- NCT04969653
- Acronym / sponsor ID
- P046
- Conditions
- Venous Thromboembolism, Atopic Dermatitis, Pulmonary Embolism, Deep Vein Thrombosis, Allergic Rhinitis, Allergy to House Dust Mite
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 754,745 participants (actual)
- Lead sponsor
- Momentum DataIndustry (pharma, biotech, devices)
- Collaborators
- Pfizer
- Study start
- 21 Jun 2021 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 1 Jul 2023 (actual)
- First posted
- 21 Jul 2021 (actual)
- Results
- Posted 9 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to investigate the incidence of venous thromboembolism in people who are diagnosed with atopic dermatitis.
Detailed 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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cases | – | Other: Exposure of venous thromboembolismAll adults with an episode of active atopic dermatitis at any point between 1st Jan 2010 to 1st Jan 2015 will be included for analysis. |
| Controls | – | Other: Exposure of venous thromboembolismAdults without atopic dermatitis or other skin conditions matched to cases by age, gender, and duration of practice registration. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exposure of venous thromboembolismComposite of pulmonary embolism and deep vein thrombosis | Other | Cases, Controls |
Primary outcome
Number of Participants With Diagnosis of Venous Thromboembolism After the Start of Follow-up for Each Person.
Time frame: 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.
11 secondary outcomes
Number of Participants With Diagnosis of Pulmonary Embolism After the Start of Follow-up for Each Person
Time frame: 10 years from index date
Number of Participants With Diagnosis of Deep-vein Thrombosis After the Start of Follow-up for Each Person
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 10 years from index date
Number of Participants Aged 45-64 With Diagnosis of Venous Thromboembolism After the Start of Follow-up for Each Person
Time frame: 10 years from index date
Number of Participants Aged ≥65 With Diagnosis of Venous Thromboembolism After the Start of Follow-up for Each Person
Time frame: 10 years from index date
Number of Participants BMI <30 With Diagnosis of Venous Thromboembolism After the Start of Follow-up for Each Person
Time frame: 10 years from index date
Number of Participants BMI ≥30 With Diagnosis of Venous Thromboembolism After the Start of Follow-up for Each Person
Time frame: 10 years from index date
Number of Female Participants Aged 18-44 Using Oestrogen Contraceptive With Diagnosis of Venous Thromboembolism After the Start of Follow-up for Each Person
Time frame: 10 years from index date
Number of Participants Having History of an Allergic Condition With Diagnosis of Venous Thromboembolism After the Start of Follow-up for Each Person
Time frame: 10 years from index date
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 37418627Warren 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.
- Individual participant dataSharing planned: Yes. OPCRD data can be accessed by bone fide researchers for specific research projects, subject to approval by Anonymised Data Ethics \& Protocol Transparency (ADEPT) Committee. The data utilised for this study cannot be made available without such approval.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew McGovern, MD study director
Momentum Data Ltd
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Venous Thromboembolism and Atopic Dermatitis, run by Momentum Data at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Diagnosis of Venous Thromboembolism After the Start of Follow-up for Each Person. (time frame: 10 years from index date). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04969653, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2024.