NCT05895123

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Damanhour University · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• ST-segment Elevation Myocardial Infarction

Interventions

Type	Name	Description
DRUG	Rosuvastatin 20 mg	patients will receive one tablet rosuvastatin 20 mg every night
DRUG	Atorvastatin 40mg	patients will receive one tablet Atorvastatin 40 mg every night

Timeline

• Start date: 2021-11-01
• Primary completion: 2023-03-01
• Completion: 2023-04-01
• First posted: 2023-06-08
• Last updated: 2024-08-01

Locations

1 site across 1 country: Egypt