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Influence of Atorvastatin on Psoriasis Severity and Endothelial Function

Primary Purpose

Psoriasis

Status

Withdrawn

Phase

Phase 3

Locations

Israel

Study Type

Interventional

Intervention

Atorvastatin

Atorvastatin placebo

About this trial

This is an interventional treatment trial for Psoriasis focused on measuring Cardiovascular Diseases, Pharmacologic Actions, Endothelial Function, Dermatology, Inflammatory Disease, Skin Disease

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Rabin Medical Center, Beilinson Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Atorvastatin

Placebo

Arm Description

Outcomes

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).

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

Secondary Outcome Measures

Full Information

NCT ID

NCT01527097

First Posted

January 15, 2012

Last Updated

November 16, 2015

Sponsor

shmuel fuchs

1. Study Identification

Unique Protocol Identification Number

NCT01527097

Brief Title

Influence of Atorvastatin on Psoriasis Severity and Endothelial Function

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 Type

Interventional

2. Study Status

Record Verification Date

November 2015

Overall Recruitment Status

Withdrawn

Why Stopped

We strongly feel that the ability to recruit the required number of patients is very low and thus decided to stop the study.

Study Start Date

August 2012 (undefined)

Primary Completion Date

April 2015 (Actual)

Study Completion Date

April 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

shmuel fuchs

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Psoriasis

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Atorvastatin

Arm Type

Experimental

Arm Title

Placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Atorvastatin

Other Intervention Name(s)

Lipitor

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Atorvastatin placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

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).

Description

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

Time Frame

3,6 and 12 months after randomization.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Shmuel Fuchs, Professor

Organizational Affiliation

Rabin Medical Center, Israel

Official's Role

Study Director

Facility Information:

Facility Name

Rabin Medical Center, Beilinson Hospital

City

Petach Tikva

ZIP/Postal Code

49100

Country

Israel

12. IPD Sharing Statement

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Influence of Atorvastatin on Psoriasis Severity and Endothelial Function

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