Status:
WITHDRAWN
Influence of Atorvastatin on Psoriasis Severity and Endothelial Function
Lead Sponsor:
shmuel fuchs
Conditions:
Psoriasis
Eligibility:
All Genders
20+ years
Phase:
PHASE3
Brief 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 ce...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2015
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01527097
Start Date
August 1 2012
End Date
April 1 2015
Last Update
November 17 2015
Active Locations (1)
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1
Rabin Medical Center, Beilinson Hospital
Petah Tikva, Israel, 49100