Status:
WITHDRAWN
SystemIc iNflammation and Microvascular diSease PreventIon in psoRiatic diseasE
Lead Sponsor:
Brigham and Women's Hospital
Collaborating Sponsors:
The Cleveland Clinic
Conditions:
Psoriasis
Psoriatic Arthritis
Eligibility:
All Genders
40-80 years
Phase:
PHASE4
Brief Summary
This is a single-label open-arm mechanistic clinical study recruiting patients with psoriasis or psoriatic arthritis with elevated cardiovascular risk. Subjects enrolled in this study will receive sta...
Detailed Description
The primary objective of this study is to investigate the impact of maximally tolerated statin (MTS) therapy on coronary flow reserve (CFR), reflecting coronary vasoreactivity and myocardial tissue pe...
Eligibility Criteria
Inclusion
- Age \> 40 years of age
- Documented evidence of PsO or PsA by a board-certified dermatologist or rheumatologist, respectively.
- Subjects on systemic therapy/phototherapy for PsO or PsA will be required to be on stable therapy for at least 3 months prior to enrollment
- Plus, documented history of at least one of the following:
- Hypertension
- Obesity (BMI \> 30)
- Diabetes Mellitus
- HsCRP \> 3 mg/L within 30 days of enrollment
Exclusion
- Patients on statin or PCSK9 inhibitor therapy, or use of statin therapy within the past year
- Documented history of other systemic inflammatory diseases, which in the opinion of the investigator would be inappropriate for enrollment.
- Prior history of untreated chronic infection (tuberculosis), severe fungal infection, or known HIV positive, chronic hepatitis B or C infection), prior history of solid malignancy, myeloproliferative or lymphoproliferative disease within 5 years, excluding treated non-melanoma skin cancer
- NYHA class IV heart failure
- Active liver disease including unexplained, persistent elevations of serum transaminases or serum transaminase elevation \> 3 x the upper limit of normal.
- Severe renal impairment
- Pregnancy
Key Trial Info
Start Date :
April 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2025
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04417114
Start Date
April 1 2021
End Date
March 31 2025
Last Update
July 23 2021
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