Influence of Intensive Lipid Lowering Treatment Compared to Moderate Lipid Lowering Treatment on Plaque Composition in Patients With ST-Segment Elevation Myocardial Infarction (MI)

Study Overview
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Brief Summary
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In patients with ST-segment elevation acute myocardial infarction (STEMI) increased LDL-cholesterol reduction (rosuvastatin 40 mg) will provide incremental plaque stabilization (changes in plaque composition) and plaque regression over 12 months beyond the benefit of moderate LDL-cholesterol reduction (rosuvastatin 5 mg) (assessed by IVUS and VH).

Official Title
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Influence of Intensive Lipid Lowering Treatment Compared to Moderate Lipid Lowering Treatment on Plaque Composition Assessed by Virtual Histology in Patients With ST-Segment Elevation Acute Myocardial Infarction (VIRHISTAMI)

Conditions
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Acute Coronary Syndrome

Intervention / Treatment
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* Drug: Rosuvastatin 5mg
* Drug: Rosuvastatin 40mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ST segment elevation acute myocardial infarction 20% < angiographic diameter stenosis < 50% on a not previously revascularized native coronary artery Statin naïve Exclusion Criteria: Pharmacologic lipid lowering treatment before index hospitalization Atrial fibrillation, not well rate-controlled Ventricle frequency variation with more than a factor 2 over 1 minute Unconscious patients Total cholesterol > 7.0 mmol/l History of statin induced myopathy, or serious hypersensitivity reaction to other HMG-CoA reductase inhibitors (statins) including rosuvastatin Pregnant women, women who are breast feeding, and women of childbearing potential who are not using chemical or mechanical contraception or have a positive serum pregnancy test (a serum-human chorionic gonadotrophin [Beta-HCG] analysis) History of malignancy (unless a documented disease free period exceeding 5-years is present) with the exception of basal cell or squamous cell carcinoma of the skin, or in the case of a study designed to investigate antineoplastic properties of rosuvastatin. Women with a history of cervical dysplasia would be permitted to enter the study provided they had 3 consecutive clear Papanicolaou (Pap) smears Uncontrolled hypothyroidism (TSH > 1.5xULN) Abnormal LFT's History of alcohol or drug abuse within the last 5 years (this may affect compliance) Current active liver disease (ALT/SGPT >2xULN or severe hepatic impairment (to protect patient safety as directed on the labels of currently approved statins) Unexplained creatine kinase (CK > 3xULN) (To protect patient safety) (will be increased at baseline because of acute ST segment elevation myocardial infarction a few days before enrolment) Serum creatinine >176mmol/L (2.0mg/dL) (unless the protocol specifically aims to investigate a chronic renal disease population) Participation in another investigational drug study less than 4 weeks before enrolment in the study, or according to subjects local ethics committee requirements where a larger period is stipulated (to avoid potential misinterpretation of overlapping adverse events) Treatments with cyclosporine Treatment with gemfibrozil

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 for one year | Drug: Rosuvastatin 5mg<br>* Rosuvastatin 5mg/day<br>* Other names: Crestor;|
| Active Comparator: Rosuvaststin 40mg<br>Rosuvastatin 40mg/day | Drug: Rosuvastatin 40mg<br>* Rosuvastatin 40mg/day<br>* Other names: Crestor;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in plaque composition (VH) in a not previously revascularized or infarct related coronary artery with an angiographic insignificant lesion (Follow up - baseline). |  | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent changes in plaque volume in a not previously revascularized coronary artery with an angiographic insignificant lesion (Follow up - baseline). |  | One year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ST-Segment Elevation Myocardial Infarction