Comparative Study Between the Effects of High Doses Rosuvastatin and Atorvastatin on Ventricular Remodeling in Patients With ST-Segment Elevation Myocardial Infarction
Overview
- Phase
- Phase 2
- Intervention
- Rosuvastatin 20 mg
- Conditions
- ST-segment Elevation Myocardial Infarction
- Sponsor
- Damanhour University
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Evaluation of the effect on ventricular remodeling
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
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
1. Ethical committee approval will be obtained from Ethics committee of Faculty of Pharmacy, Damanhour University. 2. All participants should agree to take part in this clinical study and will provide informed consent. 3. (80) patients diagnosed with STEMI will be enrolled from Alexandria university hospital. 4. Serum samples will be collected from patients at the time of admission for measuring the biomarkers. 5. Echocardiogram also will be obtained at the time of admission. 6. All enrolled patients will be divided into two group to receive either Atorvastatin (40 mg) or Rosuvastatin (20mg). 7. 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. 8. Statistical tests appropriate to the study design will be conducted to evaluate the significance of the results. 9. Results, conclusion, discussion, and recommendations will be given.
Investigators
Eligibility Criteria
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.
Arms & Interventions
Rosuvastatin group
patients will receive Rosuvastatin orally (20 mg) at night once daily
Intervention: Rosuvastatin 20 mg
Atorvastatin group
patients will receive Atorvastatin orally (40 mg) at night once daily
Intervention: Atorvastatin 40mg
Outcomes
Primary Outcomes
Evaluation of the effect on ventricular remodeling
Time Frame: 3 months
MMP9,sST2 and CRP level will be measured and monitoring the change in their levels Echocardiogram will be obtained and monitoring the change in echocardiogram indexes.
Secondary Outcomes
- Evaluation of the effect on lipid parameters and liver enzymes(3 months)