Influence of Atorvastatin on Psoriasis Severity and Endothelial Function
Information source: Rabin Medical Center
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Psoriasis
Intervention: Atorvastatin (Drug); Atorvastatin placebo (Drug)
Phase: Phase 3
Status: Not yet recruiting
Sponsored by: shmuel fuchs Official(s) and/or principal investigator(s): Shmuel Fuchs, Professor, Study Director, Affiliation: Rabin Medical Center, Israel
Overall contact: Shmuel Fuchs, Professor, Phone: 972 - 3 - 9376601, Email: shmuelf@clalit.org.il
Summary
Patients with psoriasis seem to have increased risk for developing atherosclerosis. This may
be due to the fact that psoriasis and atherosclerosis are both caused by inflammation and
involvement of cells of the immune system. Atherosclerosis is frequently treated by statins
(class of cholesterol lowering drugs), which lower bad cholesterol levels and also reduce
inflammation. Some new evidences also suggest that therapy with statins may improve
psoriasis skin disease.
The current study aims are to evaluate whether a strong statin named Atorvastatin can
improve psoriatic skin disease and functioning of the arteries. The study also aims to
evaluate if the activity of these two diseases are related to levels of common inflammatory
biomarkers (substance in blood) and whether Atorvastatin can change their levels.
Clinical Details
Official title: Atorvastatin to Reduce Psoriasis Severity and Improve Endothelial Function in Patients With Severe Psoriasis and Non-Elevated LDL Levels: A Randomized, Double Blind, Placebo-Controlled Study.
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: The primary efficacy outcome variable of the study is defined as the composite endpoint of improving of psoriatic severity and endothelial function (assessed by FMD changes).
Eligibility
Minimum age: 20 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Patients older than 20 years
- Patients with psoriasis of at least 3-years duration
- Current moderate to severe psoriatic disease (PASI ≥12, IGA≥3)
- Statin-naïve patients
- No history of cardiovascular disease (ischemic heart disease, peripheral vascular
disease or cerebrovascular disease)
- LDL levels
- LDL level > 70 mg% and < 160 mg% in low risk patients (defined as having none or
a single risk factor*)
- LDL > 70 mg% and < 130 mg% in moderate risk patients (defined as the presence of
2 or more risk factors*)
- LDL > 70 mg% and < 100 mg% in patients with type II diabetes
- hsCRP ≥ 1 mg/l * Risk factors: smoking, hypertension (blood pressure > 140/90 or
current treatment with blood pressure lowering agents, HDL < 40 mg%, family history
of premature coronary artery disease in a first degree relative younger than 45 (men)
or 55 (women) and obesity (BMI ≥ 30).
Exclusion Criteria:
- Current statin therapy
- Patents with Atrial Fibrillation
- Elevated liver enzymes (> X3 ULN)
- History of statin-induced liver enzyme elevation
- Elevated CPK levels (> X3 ULN)
- History of myopathy including statin-induced
- Severe chronic renal failure (GFR <30 ml/min)
- Pregnant or breast-feeding women
- Individuals at risk for poor protocol, or medication compliance
- Patients with life-expectancy of less than 2 years
- Patients who are currently participating in another clinical trial
- Other current active inflammatory and/or infectious conditions
- Sensitivity to any of atorvastatin ingredients
- Concomitant drug therapy, taken on a regular basis, which may interact with
Atorvastatin
Locations and Contacts
Shmuel Fuchs, Professor, Phone: 972 - 3 - 9376601, Email: shmuelf@clalit.org.il
Rabin Medical Center, Beilinson Hospital, Petach Tikva 49100, Israel; Not yet recruiting Shmuel Fuchs, Professor, Phone: 972-3-9376601\3, Email: shmuelf@clalit.org.il Maya Arlyuk, Study Coordinator, Email: mayaor@clalit.org.il Shmuel Fuchs, Professor, Principal Investigator
Additional Information
Starting date: August 2012
Last updated: June 20, 2012
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