NCT04417114WithdrawnPhase 4
SystemIc iNflammation and Microvascular diSease PreventIon in psoRiatic diseasE
Source: ClinicalTrials.gov · Last updated 23 Jul 2021
Reason given: The study was not funded.
Brief summary (registry, in English)
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 statin treatment with rosuvastatin. The statin treatment in this study will be used as an intervention with widely known pleiotropic CV risk reduction effects, including anti-inflammatory reduction. Subjects will be studied before statin therapy and followed for 48 weeks on treatment. The primary outcome will be change in the coronary flow reserve (CFR) as measured by cardiac PET. Overall, this study will examine the impact of statin therapy on changes in CFR as a reflection of impaired coronary vasoreactivity and a manifestation of myocardial ischemia, which may precede clinical CV events (and visible changes in plaque morphology) in high-risk patients with psoriatic disease.
- Status (registry)
- Withdrawn
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 0 (actual)
- First submitted
- 2 Jun 2020
- Start date
- 1 Apr 2021
- Primary completion date
- 31 Mar 2025
- Lead sponsor
- Brigham and Women's Hospital
- Diseases
- Psoriasis, Psoriatic arthritis
- NCT number
- NCT04417114
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients on statin or PCSK9 inhibitor therapy, or use of statin therapy within the past year
- 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
Other illness
- Documented history of other systemic inflammatory diseases, which in the opinion of the investigator would be inappropriate for enrollment.
- NYHA class IV heart failure
- Severe renal impairment
Lab values
- Active liver disease including unexplained, persistent elevations of serum transaminases or serum transaminase elevation > 3 x the upper limit of normal.
Other
- Pregnancy
Who the study is looking for
- 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
Age in the registry: 40 years to 80 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.