Effect of Intensive Lipid Lowering Treatment Compared to Moderate Lipid Lowering Treatment on Carotid Intima-media Thickness (CIMT)

Study Overview
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Brief Summary
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The aim of this study was to measure the effect of moderate and intensive lipid-lowering treatment with rosuvastatin on the carotid intima-media thickness (CIMT) as a surrogate marker of cardiovascular risk.

Detailed Description
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The aim of this study was to measure the effect of moderate (5mg) and intensive (40mg) lipid-lowering treatment with rosuvastatin on the carotid intima-media thickness as a surrogate marker of cardiovascular risk and to obtain whether CIMT correlated with the plaque components in coronary arteries evaluated with Intravascular Ultrasound Virtual Histology (IVUS-VH).

Official Title
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Effect of Intensive Lipid Lowering Treatment Compared to Moderate Lipid Lowering Treatment on Carotid Intima Media Thickness and Its Relation to Plaque Components of the Coronary Arteries in Patients With ST-Segment Elevation Acute Myocardial Infarction

Conditions
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ST-segment Elevation Myocardial Infarction, Subclinical Carotid Atherosclerosis

Intervention / Treatment
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* Drug: Rosuvastatin
* Drug: Rosuvastatin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: STEMI, no prior treatment with statins and a non significant lesion in one of the two non-culprit coronary arteries. - Exclusion Criteria: age below 18 or above 81 years, unconscious patients, serum creatinine > 176μmol/L, total-cholesterol > 7.0 mmol/l, hypothyroidism ((TSH > 1.5 x ULN (upper limit of normal)), current liver disease (ALAT > 2 x ULN), unexplained creatine kinase > 3 x ULN, alcohol or drug abuse within the last five years, prior myopathy or serious hypersensitivity reaction caused by statins, women with childbearing potential who were not using chemical or mechanical contraception, pregnant or breastfeeding women, history of malignancy unless a disease-free period of more than five years was present, patients with abnormal lung function test (LFT), participation in another investigational drug study less than four weeks before enrolment in the present study, treatment with cyclosporine or fibrates. -

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 81 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Rosuvastatin 5mg<br>Rosuvastatin 5mg/day | Drug: Rosuvastatin<br>* Rosuvastatin 5mg/day for one year<br>* Other names: Crestor;|
| Active Comparator: Rosuvastatin 40mg<br>Rosuvastatin 40mg/day | Drug: Rosuvastatin<br>* Rosuvastatin 40mg/day for one year<br>* Other names: Crestor;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change from baseline in mean CIMT | Average of the far wall of common and bulbus carotid artery | baseline, 6month, 12 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes from baseline in max CIMT |  | baseline, 6month, 12 month | 
| change from baseline in mean common CIMT |  | baaseline, 6month 12 month | 
| change from baseline in max common CIMT |  | baseline, 6month 12month | 
| change from baseline in mean bulbus CIMT |  | Baseline, 6month 12 month | 
| change from baseline in max bulbus CIMT |  | baseline, 6month 12month | 
| change from baseline in lipid values |  | baseline, 6month 12month | 
| correlation between CIMT measurements and lipid values |  | Baseline, 6month 12 month | 
| correlation between CIMT measurements and plaque components evaluated by IVUS-VH |  | Baseline, 6month 12month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CIMT, IVUS-VH, Coronary artery disease