Clinical trial NCT05895123: Comparison Between the Effects of High Doses Statin on Ventricular Remodeling in STEMI Patients
Official title: Comparative Study Between the Effects of High Doses Rosuvastatin and Atorvastatin on Ventricular Remodeling in Patients With ST-Segment Elevation Myocardial Infarction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: ST-segment Elevation Myocardial Infarction
Keywords: Statin
remodeling
STEMI
Lead sponsor: Damanhour University
Sponsor class: OTHER
Collaborators: name: Alexandria University
First posted: 2023-06-08
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized control trial
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Evaluation of the effect on ventricular remodeling
timeFrame: 3 months
Secondary outcomes:
measure: Evaluation of the effect on lipid parameters and liver enzymes
timeFrame: 3 months
Other outcomes:
Locations:
city: Damanhūr
country: Egypt
facility: Damanhour University
Study officials:
affiliation: demonstrator of Clinical Pharmacy, Damanhour University.
name: Zeinab M Elhadad, bachelor
role: PRINCIPAL_INVESTIGATOR
affiliation: Lecturer of Clinical Pharmacy, Damanhour University.
name: Amira B Kassem, PhD
role: STUDY_DIRECTOR
affiliation: Lecturer of biochemisrty, Damanhour University.
name: Ahmed salahaldin, PHD
role: STUDY_DIRECTOR
affiliation: Lecturer of Clinical Pharmacy, Damanhour University.
name: noha ahmad, PHD
role: STUDY_CHAIR
affiliation: Lecturer of cardiology , Faculty of medicine, Alexandria University.
name: ahmad alamrawy, PHD
role: STUDY_CHAIR
References:
citation: Khurana S, Gupta S, Bhalla H, Nandwani S, Gupta V. Comparison of anti-inflammatory effect of atorvastatin with rosuvastatin in patients of acute coronary syndrome. J Pharmacol Pharmacother. 2015 Jul-Sep;6(3):130-5. doi: 10.4103/0976-500X.162011.
citation: Sutton MG, Sharpe N. Left ventricular remodeling after myocardial infarction: pathophysiology and therapy. Circulation. 2000 Jun 27;101(25):2981-8. doi: 10.1161/01.cir.101.25.2981. No abstract available.
citation: Reddy R, Chahoud G, Mehta JL. Modulation of cardiovascular remodeling with statins: fact or fiction? Curr Vasc Pharmacol. 2005 Jan;3(1):69-79. doi: 10.2174/1570161052773915.
citation: Berezin AE, Berezin AA. Adverse Cardiac Remodelling after Acute Myocardial Infarction: Old and New Biomarkers. Dis Markers. 2020 Jun 12;2020:1215802. doi: 10.1155/2020/1215802. eCollection 2020.
citation: Neri M, Riezzo I, Pascale N, Pomara C, Turillazzi E. Ischemia/Reperfusion Injury following Acute Myocardial Infarction: A Critical Issue for Clinicians and Forensic Pathologists. Mediators Inflamm. 2017;2017:7018393. doi: 10.1155/2017/7018393. Epub 2017 Feb 13.