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We strongly feel that the ability to recruit the required number of patients is very low and thus decided to stop the study.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Atorvastatin | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atorvastatin | Drug | Drug: Atorvastatin 80 mg for 6 months following by 40 mg for additional 6 months once daily. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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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
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:
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| Name | Affiliation | Role |
|---|---|---|
| Shmuel Fuchs, Professor | Rabin Medical Center, Israel | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rabin Medical Center, Beilinson Hospital | Petah Tikva | 49100 | Israel |
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| ID | Term |
|---|---|
| D011565 | Psoriasis |
| D002318 | Cardiovascular Diseases |
| D012871 | Skin Diseases |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D000069059 | Atorvastatin |
| ID | Term |
|---|---|
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Atorvastatin placebo | Drug | Atorvastatin 80mg during 6 month and 40mg in additional 6 month period once daily. |
|
| D006538 |
| Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |