Effect of Crestor (Rosuvastatin) on Lipid Levels in Patients With Metabolic Syndrome

Study Overview
=================
Brief Summary
-----------------
The primary objective is to evaluate the efficacy of rosuvastatin therapy on plasma lipid profile (Low Density Lipoprotein (LDL), High-Density Lipoprotein (HDL), total cholesterol, triglyceride) in patients with metabolic syndrome.

Official Title
-----------------
Open-labelled, Single Arm, Phase IV Clinical Study to Evaluate the Impact of Rosuvastatin on Lipid Levels in Patients With Metabolic Syndrome (EFFORT)

Conditions
-----------------
Metabolic Syndrome

Intervention / Treatment
-----------------
* Drug: rosuvastatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: metabolic syndrome (according to National Cholesterol Education Program (NCEP) Adenosine triphosphate (ATP) Ill criteria) LDL-Cholesterol > 130mg/dl HDL-Cholesterol < 40mg/dl in males and <50mg/dl in females Triglycerides < 400 mg/dl Exclusion Criteria: With a concomitant coronary disease Currently under statin therapy or previously treated with statins within the last 6 months

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 69 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rosuvastatin<br>medication start dose is 10mg. After 6 weeks of treatment will be force-titrated to 20mg. | Drug: rosuvastatin<br>* medication start dose is 10mg. After 6 weeks of treatment will be force-titrated to 20mg.<br>* Other names: CRESTOR;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Basal HDL-cholesterol Level | HDL-cholesterol levels before (mean of visit 1 - screening and Visit 2 - enrollment) | Baseline | 
| HDL-cholesterol Level After 3 Months of Rosuvastatin Treatment | HDL- cholesterol levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF) | 3 months (from enrollment to last visit) | 
| Basal LDL-cholesterol Level | LDL-cholesterol levels before (mean of visit 1 - screening and Visit 2 - enrollment) | Baseline | 
| LDL-cholesterol Level After 3 Months of Rosuvastatin Treatment | LDL- cholesterol levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF) | 3 months (from enrollment to last visit) | 
| Basal Total Cholesterol Level | Baseline | Total cholesterol levels before (mean of visit 1 - screening and Visit 2 - enrollment) | 
| Total Cholesterol Level After 3 Months of Rosuvastatin Treatment | Total cholesterol after 3 months of rosuvastatin treatment (last observation carried forward; LOCF) | 3 months (from enrollment to last visit) | 
| Basal Triglyceride Level | Triglyceride levels before (mean of visit 1 - screening and Visit 2 - enrollment) | Baseline | 
| Triglyceride Level After 3 Months of Rosuvastatin Treatment | Triglycerides after 3 months of rosuvastatin treatment (last observation carried forward; LOCF) | 3 months (from enrollment to last visit) | 
| Number of Patients Who Reached Target Level of LDL-cholesterol After 3 Months of Rosuvastatin Treatment | Number of patients who reached target level of LDL-cholesterol after 3 months of rosuvastatin treatment. Target level: LDL-cholesterol: <100 mg/dL; HDL-cholesterol: For males >40 mg/dL, for females >50 mg/dL; non-HDL-cholesterol: <130 mg/dL | 3 months (from enrollment to last visit) | 
| Number of Patients Who Reached Target Level of HDL-cholesterol After 3 Months of Rosuvastatin Treatment | Number of patients who reached target level of HDL-cholesterol after 3 months of rosuvastatin treatment | 3 months (from enrollment to last visit) | 
| Number of Patients Who Reached Target Level of Non-HDL-cholesterol After 3 Months of Rosuvastatin Treatment | Number of patients who reached target level of non-HDL-cholesterol after 3 months of rosuvastatin treatment | 3 months (from enrollment to last visit) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Basal Interleukin 1 (IL-1) Level | IL-1 levels before (Visit 2-enrollment) | Baseline | 
| Interleukin 1 (IL-1) Level After 3 Months of Rosuvastatin Treatment | IL-1 levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF) | 3 months (from enrollment to last visit) | 
| Basal Interleukin 6 (IL-6) Level | IL-6 levels before (Visit 2-enrollment) | Baseline | 
| Interleukin 6 (IL-6) Level After 3 Months of Rosuvastatin Treatment | IL-6 levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF) | 3 months (from enrollment to last visit) | 
| Basal Interleukin 8 (IL-8) Level | IL-8 levels before (Visit 2-enrollment) | Baseline | 
| Interleukin 8 (IL-8) Level After 3 Months of Rosuvastatin Treatment | IL-8 levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF) | 3 months (from enrollment to last visit) | 
| Basal Interleukin 10 (IL-10) Level | IL-10 levels before (Visit 2-enrollment) | Baseline | 
| Interleukin 10 (IL-10) Level After 3 Months of Rosuvastatin Treatment | IL-10 levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF) | 3 months (from enrollment to last visit) | 
| Basal Tumor Necrosis Factor (TNF) Level | TNF levels before (Visit 2-enrollment) | Baseline | 
| Tumor Necrosis Factor (TNF) Level After 3 Months of Rosuvastatin Treatment | TNF levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF) | 3 months (from enrollment to last visit) | 
| Basal High Sensitivity C-reactive Protein (Hs-CRP) Level | hs-CRP levels before (Visit 2-enrollment) | Baseline | 
| High Sensitivity C-reactive Protein (Hs-CRP) Level After 3 Months of Rosuvastatin Treatment | hs-CRP levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF) | 3 months (from enrollment to last visit) | 
| Basal LDL-3 Level | LDL subfractions are light (LDL1 and 2), intermediate (LDL3) and small dense LDL (LDL 4, 5, 6 and 7). Small dense LDL (sdLDL)-cholesterol that expresses greater atherogenicity than large buoyant LDL. Large LDL particles are the least likely to cause plaque formation, because LDL particles have to be approximately 25 nm in diameter or smaller to penetrate the artery walls. High sdLDL and decreased large HDL fraction are more common in patients with coronary heart disease than in controls | Baseline | 
| LDL-3 Level After 3 Months of Rosuvastatin Treatment | LDL-3 levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF) | 3 months (from enrollment to last visit) | 
| Basal LDL-4 Level | LDL-4 levels before (Visit 2-enrollment) | Baseline | 
| LDL-4 Level After 3 Months of Rosuvastatin Treatment | LDL-4 levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF) | 3 months (from enrollment to last visit) | 
| Basal LDL-5 Level | LDL-5 levels before (Visit 2-enrollment) | Baseline | 
| LDL-5 Level After 3 Months of Rosuvastatin Treatment | LDL-5 levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF) | 3 months (from enrollment to last visit) | 
| Basal LDL-6 Level | LDL-6 levels before (Visit 2-enrollment) | Baseline | 
| LDL-6 Level After 3 Months of Rosuvastatin Treatment | LDL-6 levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF) | 3 months (from enrollment to last visit) | 
| Basal LDL-7 Level | LDL-7 levels before (Visit 2-enrollment) | Baseline | 
| LDL-7 Level After 3 Months of Rosuvastatin Treatment | LDL-7 levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF) | 3 months (from enrollment to last visit) | 
| Basal Large HDL Subfraction Level | Large HDL subfraction levels before (Visit 2-enrollment) | Baseline | 
| Large HDL Subfraction Level After 3 Months of Rosuvastatin Treatment | Large HDL subfraction levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF) | 3 months (from enrollment to last visit) | 
| Basal Intermediate HDL Subfraction Level | Intermediate HDL subfraction levels before (Visit 2-enrollment) | Baseline | 
| Intermediate HDL Subfraction Level After 3 Months of Rosuvastatin Treatment | Intermediate HDL subfraction levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF) | 3 months (from enrollment to last visit) | 
| Basal Small HDL Subfraction Level | Small HDL subfraction levels before (Visit 2-enrollment) | Baseline | 
| Small HDL Subfraction Level After 3 Months of Rosuvastatin Treatment | Small HDL subfraction levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF) | 3 months (from enrollment to last visit) | 
| Number of Patients With Adverse Events | Number of patients with any adverse events in 3 months of rosuvastatin treatment | 3 months (from enrollment to last visit) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
plasma lipid profile, metabolic syndrome