Clinical trial

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

Name
statinstudy
Description
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
Trial arms
Trial start
2022-10-01
Estimated PCD
2023-03-01
Trial end
2023-04-01
Status
Completed
Phase
Early phase I
Treatment
Rosuvastatin 20 mg ,40 mg
patients will receive one tablet rosuvastatin 20-40 mg every night
Arms:
Rosuvastatin group
Other names:
cholerose
Atorvastatin 40mg,80mg
patients will receive one tablet Atorvastatin 20-40 mg every night
Arms:
Atorvastatin group
Other names:
ator
Size
80
Primary endpoint
Evaluation of the effect on ventricular remodeling
3 months
Eligibility criteria
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized control trial', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 80, 'type': 'ACTUAL'}}
Updated at
2023-06-08

1 organization

2 products

1 indication