Cardiovascular DiseasesPhase 4NCT03228017
Subclinical Cardiovascular Disease in Psoriatic Disease
A Phase 4 study testing Aspirin and/or Atorvastatin in people with Cardiovascular Diseases and Myocardial Infarction, run by NYU Langone Health at 1 site in United States.
Trial summary
This study will look at how chronic inflammation seen in psoriatic disease translates into the increased atherosclerotic and thrombotic risk and how treatment reduces this CVD risk. The Aim of this study is to 1) Evaluate the association between moderate to severe psoriatic disease and measures of vascular function. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases, Myocardial Infarction, Atherosclerotic Cardiovascular Disease
- What is being tested?
- Aspirin and/or Atorvastatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2017to 1 Apr 2019
- Phase
- Phase 4
- 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 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects with a history of moderate to severe psoriatic disease
- Group 2: Healthy subjects without known psoriatic disease or cardiovascular disease
Who cannot join
- Unable to speak Spanish or English
- Active smoking (within the past year)
- Autoimmune, rheumatologic or inflammatory disease which are not psoriasis or psoriatic arthritis
- Known active cancer receiving treatment
- Pregnancy
- Anemia (hemoglobin < 9 mg/dl) or thrombocytopenia (Platelet count <75), or thrombocytosis (Platelet count >600)
Show all 12Show fewer
- A history of severe bleeding or bleeding disorders
- Current medication use which interact with either aspirin or atorvastatin
- Chronic kidney disease (CrCl < 30ml/min)
- Congestive heart failure
- Currently taking aspirin or a statin.
- NSAID use within the past 48 hours
Trial locations and contacts
1 site in 1 country.
United States1 site
New York University School of Medicine
New York, New York, 10016
About this study
This study will look at how chronic inflammation seen in psoriatic disease translates into the increased atherosclerotic and thrombotic risk and how treatment reduces this CVD risk. The Aim of this study is to 1) Evaluate the association between moderate to severe psoriatic disease and measures of vascular function. 2) Evaluate the association between moderate to severe psoriatic disease and measures of thrombotic risk. 3) Understand how traditional medications used in cardiovascular disease (CVD) prevention such as aspirin and statins affect vascular function and thrombotic risk in those with moderate to severe psoriatic disease.
Read the detailed description
Cardiovascular disease (CVD) remains the leading cause of death in the US. Five modifiable risk factors: smoking, hyperlipidemia, diabetes, hypertension and obesity, account for 50% of CVD mortality between the ages of 45 - 79.1 These traditional cardiac risk factors dictate who to treat with primary prevention measures but do not take into account patient-specific disease states such as psoriatic disease including psoriasis and psoriatic arthritis, which predispose to chronic inflammation. Patients with psoriatic disease have an increased risk of atherosclerotic heart disease and myocardial infarctions compared to matched controls.
- Conditions
- Cardiovascular Diseases, Myocardial Infarction, Atherosclerotic Cardiovascular Disease, Thrombotic Vascular Disease
- Being tested
- Aspirin and/or Atorvastatin
- Keywords
- cardiovascular disease, CVD
- Medical subject headings
- Cardiovascular Diseases, Myocardial Infarction, Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aspirin and/or AtorvastatinDrug
This follow-up will allow us to assess how aspirin and/or atorvastatin affect platelet and endothelial function and inflammation.
| Study group | Role | What they receive |
|---|---|---|
| Psoriatic Disease Patients | Other | Moderate to severe psoriatic disease Receives: Drug: Aspirin and/or Atorvastatin |
| Healthy Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Fold Change in Brachial Vein Endothelial Inflammatory Transcript
Endothelial sampling coupled to real-time PCR analysis will be used to monitor brachial vein endothelial inflammation
Measured: Baseline, 5 Months
Secondary outcomes (3)
Fold Change Change in Composite Endothelial Inflammation
Endothelial inflammation will be monitored after 2 weeks of aspirin 81mg therapy
Measured: Baseline (pre-Aspirin), 2 weeks (post-Aspirin)
Fold Change in Composite Endothelial Inflammation
Endothelial inflammation will be monitored after 2- weeks of 40mg of atorvastatin therapy.
Measured: Baseline (pre-Atorvastatin), 2 weeks (post-Atorvastatin)
Change in Levels of Circulating Thromboxane B2
Platelet activation is measured by levels of circulating thromboxane b2, which will be measured after 2- weeks of aspirin 81mg therapy
Measured: Baseline (pre-Aspirin), 2 weeks (post-Aspirin)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2017
- Study start1 Aug 2017
- Primary completion1 Apr 2019
- Study completion1 Apr 2019
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 (3)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jeffrey Berger, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03228017
- Sponsor's protocol ID
- 17-00692
- Status last verified
- Aug 2021
- First submitted
- 11 Jul 2017
- Last updated
- 28 Sep 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Garshick MS, Block R, Drenkova K, Tawil M, James G, Brenna JT. Statin therapy upregulates arachidonic acid status via enhanced endogenous synthesis in patients with plaque psoriasis. Prostaglandins Leukot Essent Fatty Acids. 2022 May;180:102428. doi: 10.1016/j.plefa.2022.102428. Epub 2022 Apr 16.
PubMed 35490599Garshick MS, Tawil M, Barrett TJ, Salud-Gnilo CM, Eppler M, Lee A, Scher JU, Neimann AL, Jelic S, Mehta NN, Fisher EA, Krueger JG, Berger JS. Activated Platelets Induce Endothelial Cell Inflammatory Response in Psoriasis via COX-1. Arterioscler Thromb Vasc Biol. 2020 May;40(5):1340-1351. doi: 10.1161/ATVBAHA.119.314008. Epub 2020 Mar 5.
PubMed 32131611Garshick MS, Barrett TJ, Wechter T, Azarchi S, Scher JU, Neimann A, Katz S, Fuentes-Duculan J, Cannizzaro MV, Jelic S, Fisher EA, Krueger JG, Berger JS. Inflammasome Signaling and Impaired Vascular Health in Psoriasis. Arterioscler Thromb Vasc Biol. 2019 Apr;39(4):787-798. doi: 10.1161/ATVBAHA.118.312246.
PubMed 30760013
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Subclinical Cardiovascular Disease in Psoriatic Disease
- ClinicalTrials.gov ID
- NCT03228017
- Acronym / sponsor ID
- 17-00692
- Conditions
- Cardiovascular Diseases, Myocardial Infarction, Atherosclerotic Cardiovascular Disease, Thrombotic Vascular Disease
- Keywords
- cardiovascular disease, CVD
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 1 Apr 2019 (actual)
- Study completion
- 1 Apr 2019 (actual)
- First posted
- 24 Jul 2017 (actual)
- Results
- Posted 28 Sep 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will look at how chronic inflammation seen in psoriatic disease translates into the increased atherosclerotic and thrombotic risk and how treatment reduces this CVD risk. The Aim of this study is to 1) Evaluate the association between moderate to severe psoriatic disease and measures of vascular function. 2) Evaluate the association between moderate to severe psoriatic disease and measures of thrombotic risk. 3) Understand how traditional medications used in cardiovascular disease (CVD) prevention such as aspirin and statins affect vascular function and thrombotic risk in those with moderate to severe psoriatic disease.
Detailed description
Cardiovascular disease (CVD) remains the leading cause of death in the US. Five modifiable risk factors: smoking, hyperlipidemia, diabetes, hypertension and obesity, account for 50% of CVD mortality between the ages of 45 - 79.1 These traditional cardiac risk factors dictate who to treat with primary prevention measures but do not take into account patient-specific disease states such as psoriatic disease including psoriasis and psoriatic arthritis, which predispose to chronic inflammation. Patients with psoriatic disease have an increased risk of atherosclerotic heart disease and myocardial infarctions compared to matched controls.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Psoriatic Disease Patients | Other | Drug: Aspirin and/or AtorvastatinModerate to severe psoriatic disease |
| Healthy Control | No intervention | – |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subjects with a history of moderate to severe psoriatic disease
- Group 2: Healthy subjects without known psoriatic disease or cardiovascular disease
Key exclusion criteria (12 listed)
- Unable to speak Spanish or English
- Active smoking (within the past year)
- Autoimmune, rheumatologic or inflammatory disease which are not psoriasis or psoriatic arthritis
- Known active cancer receiving treatment
- Pregnancy
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 |
|---|---|---|
| Aspirin and/or AtorvastatinThis follow-up will allow us to assess how aspirin and/or atorvastatin affect platelet and endothelial function and inflammation. | Drug | Psoriatic Disease Patients |
Primary outcome
Mean Fold Change in Brachial Vein Endothelial Inflammatory Transcript
Time frame: Baseline, 5 Months
Endothelial sampling coupled to real-time PCR analysis will be used to monitor brachial vein endothelial inflammation
3 secondary outcomes
Fold Change Change in Composite Endothelial Inflammation
Time frame: Baseline (pre-Aspirin), 2 weeks (post-Aspirin)
Fold Change in Composite Endothelial Inflammation
Time frame: Baseline (pre-Atorvastatin), 2 weeks (post-Atorvastatin)
Change in Levels of Circulating Thromboxane B2
Time frame: Baseline (pre-Aspirin), 2 weeks (post-Aspirin)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35490599Garshick MS, Block R, Drenkova K, Tawil M, James G, Brenna JT. Statin therapy upregulates arachidonic acid status via enhanced endogenous synthesis in patients with plaque psoriasis. Prostaglandins Leukot Essent Fatty Acids. 2022 May;180:102428. doi: 10.1016/j.plefa.2022.102428. Epub 2022 Apr 16.
- Derived from this study: PubMed 32131611Garshick MS, Tawil M, Barrett TJ, Salud-Gnilo CM, Eppler M, Lee A, Scher JU, Neimann AL, Jelic S, Mehta NN, Fisher EA, Krueger JG, Berger JS. Activated Platelets Induce Endothelial Cell Inflammatory Response in Psoriasis via COX-1. Arterioscler Thromb Vasc Biol. 2020 May;40(5):1340-1351. doi: 10.1161/ATVBAHA.119.314008. Epub 2020 Mar 5.
- Derived from this study: PubMed 30760013Garshick MS, Barrett TJ, Wechter T, Azarchi S, Scher JU, Neimann A, Katz S, Fuentes-Duculan J, Cannizzaro MV, Jelic S, Fisher EA, Krueger JG, Berger JS. Inflammasome Signaling and Impaired Vascular Health in Psoriasis. Arterioscler Thromb Vasc Biol. 2019 Apr;39(4):787-798. doi: 10.1161/ATVBAHA.118.312246.
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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.
Jeffrey Berger, MD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Aspirin and/or Atorvastatin in people with Cardiovascular Diseases and Myocardial Infarction, run by NYU Langone Health at 1 site in United States.
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 2 inclusion and 12 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 28 Sep 2021. 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 States. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Sep 2021). 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?
Mean Fold Change in Brachial Vein Endothelial Inflammatory Transcript (time frame: Baseline, 5 Months). 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 NCT03228017, which also lists 3 linked publications.
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 28 Sep 2021.