SystemIc iNflammation and Microvascular diSease PreventIon in psoRiatic diseasE

NCT04417114 | Withdrawn Phase 4 FDA Drug

• 1 other identifier: BWH TBD
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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 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.

Conditions

Psoriasis; Psoriatic Arthritis; Cardiovascular Risk Factor

Keywords

Coronary microvascular function

Outcome Measures

Primary Outcomes (1)

• Change in Coronary Flow Reserve (CFR)

  CFR will be measured by cardiac PET at baseline prior to initiating treatment and following 12 months of statin therapy.

  Baseline and 12 months

Secondary Outcomes (3)

• Change in the total coronary plaque burden measured by cardiac CT angiography (CCTA)

  Baseline and 12 months

• Change in change in LV peak global longitudinal strain (GLS) (systolic function), measured by transthoracic echocardiogram (TTE)

  Baseline and 12 months

• Change in tissue Doppler mitral annular early diastolic relaxation velocity (E') (diastolic function), measured by transthoracic echocardiogram (TTE)

  Baseline and 12 months

Study Arms (1)

Single-Arm Open label

EXPERIMENTAL

This is a single-arm open label mechanistic clinical trial. Subjects will be treated with rosuvastatin at a dose of 20mg/day and uptitrated as tolerated to a dose of 40mg/day.

Drug: Rosuvastatin

Interventions

Rosuvastatin DRUG

Statin

Also known as: Crestor

Single-Arm Open label

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• The Cleveland Clinic: collaborator

MeSH Terms

Conditions

Psoriasis; Arthritis, Psoriatic

Interventions

Rosuvastatin Calcium

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Marcelo Di Carli, MD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Division of Nuclear Medicine and Molecular Imaging, Executive Director CV Imaging Program, Principal Investigator, Seltzer Family Professor of Radiology and Medicine

Study Record Dates

• First Submitted: June 2, 2020
• First Posted: June 4, 2020
• Study Start: April 1, 2021
• Primary Completion: March 31, 2025
• Study Completion: March 31, 2025
• Last Updated: July 23, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share