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Influence of Atorvastatin on Psoriasis Severity and Endothelial Function

NCT ID: NCT01527097

Last Updated: 2015-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2015-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Psoriasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Atorvastatin

Group Type EXPERIMENTAL

Atorvastatin

Intervention Type DRUG

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

Placebo

Group Type PLACEBO_COMPARATOR

Atorvastatin placebo

Intervention Type DRUG

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

Interventions

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Atorvastatin

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

Intervention Type DRUG

Atorvastatin placebo

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

Intervention Type DRUG

Other Intervention Names

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Lipitor

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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shmuel fuchs

OTHER

Sponsor Role lead

Responsible Party

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shmuel fuchs

Prof Shmuel Fuchs, MD, MACC, FSCAI

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Shmuel Fuchs, Professor

Role: STUDY_DIRECTOR

Rabin Medical Center, Israel

Locations

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Rabin Medical Center, Beilinson Hospital

Petah Tikva, , Israel

Site Status

Countries

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Israel

Other Identifiers

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0263 - 11 - RMC

Identifier Type: -

Identifier Source: org_study_id