Influence of Atorvastatin on Psoriasis Severity and Endothelial Function

NCT01527097 | Withdrawn Phase 3

• 1 other identifier: 0263 - 11 - RMC
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Psoriasis

Keywords

Cardiovascular Diseases; Pharmacologic Actions; Endothelial Function; Dermatology; Inflammatory Disease; Skin Disease

Outcome Measures

Primary Outcomes (1)

• 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).

  Patient invited to clinic visits at 3,6 and 12 month follow up.At this visits in addition primary outcome will be measured.

  3,6 and 12 months after randomization.

Study Arms (2)

Atorvastatin

EXPERIMENTAL

Drug: Atorvastatin

Placebo

PLACEBO COMPARATOR

Drug: Atorvastatin placebo

Interventions

Atorvastatin DRUG

Drug: Atorvastatin 80 mg for 6 months following by 40 mg for additional 6 months once daily.

Also known as: Lipitor

Atorvastatin

Atorvastatin placebo DRUG

Atorvastatin 80mg during 6 month and 40mg in additional 6 month period once daily.

Placebo

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• shmuel fuchs: lead

Study Sites (1)

Rabin Medical Center, Beilinson Hospital

Petah Tikva, 49100, Israel

Location

MeSH Terms

Conditions

Psoriasis; Cardiovascular Diseases; Skin Diseases

Interventions

Atorvastatin

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids

Study Officials

• Shmuel Fuchs, Professor

  Rabin Medical Center, Israel

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof Shmuel Fuchs, MD, MACC, FSCAI

Study Record Dates

• First Submitted: January 15, 2012
• First Posted: February 6, 2012
• Study Start: August 1, 2012
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: November 17, 2015

Record last verified: 2015-11

Locations

IL (1)