Comparison Between the Effects of High Doses Statin on Ventricular Remodeling in STEMI Patients

Study Overview
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Brief Summary
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STEMI is a serious type of coronary heart disease, which is a major cause of disability and death. Morphologically the key feature of remodeling is myocyte hypertrophy, myocyte loss from necrosis or apoptosis, as well as interstitial cell growth especially fibroblast proliferation leading to myocardial fibrosis . Elevated serum LDL-cholesterol concentrations play a proatherogenic role by stimulating inflammation and oxidative processes. Statins have been documented to retard fibrosis and ventricular hypertrophy by the cessation of myofibroblast activity. Clinical studies have proven that statins not only regulate lipids but also improve myocardial fibrosis, regulate cell proliferation and apoptosis, regulate ventricular remodeling, and protect the myocardium

Detailed Description
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Ethical committee approval will be obtained from Ethics committee of Faculty of Pharmacy, Damanhour University. All participants should agree to take part in this clinical study and will provide informed consent. (80) patients diagnosed with STEMI will be enrolled from Alexandria university hospital. Serum samples will be collected from patients at the time of admission for measuring the biomarkers. Echocardiogram also will be obtained at the time of admission. All enrolled patients will be divided into two group to receive either Atorvastatin (40-80 mg) or Rosuvastatin (20-40mg). All patients will be followed up during 3 months' period. At the end of 3 months, Serum samples will be collected from patients for measuring the biomarkers and Echocardiogram will be repeated. Statistical tests appropriate to the study design will be conducted to evaluate the significance of the results. Results, conclusion, discussion, and recommendations will be given.

Official Title
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Comparative Study Between the Effects of High Doses Rosuvastatin and Atorvastatin on Ventricular Remodeling in Patients With ST-Segment Elevation Myocardial Infarction

Conditions
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ST-segment Elevation Myocardial Infarction

Intervention / Treatment
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* Drug: Rosuvastatin 20 mg ,40 mg
* Drug: Atorvastatin 40mg,80mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Electrocardiogram showed abnormal elevation of the ST segment. First myocardial infarction occurred. The patients received one-stage percutaneous coronary intervention (PCI) therapy within 12 h. Exclusion Criteria: Severe cardiac insufficiency. Hepatic insufficiency (continuous increase of serum transaminase more than 3 times of the upper limit of normal level). Renal insufficiency (creatinine clearance rate <30 mL/min). Addition of others blood lipid lowering and antioxidant drugs during follow up period. Familial hypercholesterolemia. Malignant tumor. Immune system disease. Acute infectious disease. Hypersensitivity to rosuvastatin and Atorvastatin.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 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
Interventional Model Description: Randomized control trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rosuvastatin group<br>patients will receive Rosuvastatin orally (20-40 mg) at night once daily | Drug: Rosuvastatin 20 mg ,40 mg<br>* patients will receive one tablet rosuvastatin 20-40 mg every night<br>* Other names: cholerose;|
| Experimental: Atorvastatin group<br>patients will receive Atorvastatin orally (40-80 mg) at night once daily | Drug: Atorvastatin 40mg,80mg<br>* patients will receive one tablet Atorvastatin 20-40 mg every night<br>* Other names: ator;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the effect on ventricular remodeling | Echocardiogram will be obtained and monitoring the change in echocardiogram indexes. | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Statin, remodeling, STEMI