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

Damanhour University

Status and phase: Completed; Phase 2

Conditions: ST-segment Elevation Myocardial Infarction

Treatments: Drug: Atorvastatin 40mg; Drug: Rosuvastatin 20 mg

Study type: Interventional

Funder types: Other

Identifiers

NCT05895123

statinstudy

Details and patient eligibility

About

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

Full 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.

Enrollment: 80 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Electrocardiogram showed abnormal elevation of the ST segment.
2. First myocardial infarction occurred.
3. The patients received one-stage percutaneous coronary intervention (PCI) therapy within 12 h.

Exclusion criteria

1. Severe cardiac insufficiency.
2. Hepatic insufficiency (continuous increase of serum transaminase more than 3 times of the upper limit of normal level).
3. Renal insufficiency (creatinine clearance rate <30 mL/min).
4. Addition of others blood lipid lowering and antioxidant drugs during follow up period.
5. Familial hypercholesterolemia.
6. Malignant tumor.
7. Immune system disease.
8. Acute infectious disease.
9. Hypersensitivity to rosuvastatin and Atorvastatin.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 2 patient groups

Rosuvastatin group

Experimental group

Description:

patients will receive Rosuvastatin orally (20 mg) at night once daily

Treatment:

Drug: Rosuvastatin 20 mg

Atorvastatin group

Experimental group

Description:

patients will receive Atorvastatin orally (40 mg) at night once daily

Treatment:

Drug: Atorvastatin 40mg