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Influence of Atorvastatin on Psoriasis Severity and Endothelial Function

This study is not yet open for participant recruitment.
Verified June 2012 by Rabin Medical Center
Sponsor:
Information provided by (Responsible Party):
shmuel fuchs, Rabin Medical Center
ClinicalTrials.gov Identifier:
NCT01527097
First received: January 15, 2012
Last updated: June 20, 2012
Last verified: June 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Psoriasis
 Drug: Atorvastatin
Drug: Atorvastatin placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Rabin Medical Center:

Primary Outcome Measures:
  • 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). [ Time Frame: 3,6 and 12 months after randomization. ] [ Designated as safety issue: No ]
    Patient invited to clinic visits at 3,6 and 12 month follow up.At this visits in addition primary outcome will be measured.


Estimated Enrollment: 110
Study Start Date: August 2012
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Atorvastatin Drug: Atorvastatin
Drug: Atorvastatin 80 mg for 6 months following by 40 mg for additional 6 months once daily.
Other Name: Lipitor
Placebo Comparator: Placebo Drug: Atorvastatin placebo
Atorvastatin 80mg during 6 month and 40mg in additional 6 month period once daily.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01527097

Contacts
Contact: Shmuel Fuchs, Professor 972 - 3 - 9376601 shmuelf@clalit.org.il
Contact: Maya Arlyuk, Study Coordinator mayaor@clalit.org.il

Locations
Israel
Rabin Medical Center, Beilinson Hospital Not yet recruiting
Petach Tikva, Israel, 49100
Contact: Shmuel Fuchs, Professor     972-3-9376601\3     shmuelf@clalit.org.il    
Contact: Maya Arlyuk, Study Coordinator         mayaor@clalit.org.il    
Principal Investigator: Shmuel Fuchs, Professor            
Sponsors and Collaborators
shmuel fuchs
Investigators
Study Director: Shmuel Fuchs, Professor Rabin Medical Center, Israel
  More Information

No publications provided

Responsible Party: shmuel fuchs, Prof Shmuel Fuchs, MD, MACC, FSCAI, Rabin Medical Center
ClinicalTrials.gov Identifier: NCT01527097     History of Changes
Other Study ID Numbers: 0263 - 11 - RMC
Study First Received: January 15, 2012
Last Updated: June 20, 2012
Health Authority: Israel: Ministry of Health

Keywords provided by Rabin Medical Center:
Cardiovascular Diseases
Pharmacologic Actions
Endothelial Function
 Dermatology
Inflammatory Disease
Skin Disease

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Atorvastatin
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
 Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 22, 2013