Comparison Between the Effects of High Doses Statin on Ventricular Remodeling in STEMI Patients
NCT ID: NCT05895123
Last Updated: 2024-08-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
80 participants
INTERVENTIONAL
2021-11-01
2023-04-01
Brief Summary
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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
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Rosuvastatin group
patients will receive Rosuvastatin orally (20 mg) at night once daily
Rosuvastatin 20 mg
patients will receive one tablet rosuvastatin 20 mg every night
Atorvastatin group
patients will receive Atorvastatin orally (40 mg) at night once daily
Atorvastatin 40mg
patients will receive one tablet Atorvastatin 40 mg every night
Interventions
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Rosuvastatin 20 mg
patients will receive one tablet rosuvastatin 20 mg every night
Atorvastatin 40mg
patients will receive one tablet Atorvastatin 40 mg every night
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. First myocardial infarction occurred.
3. The patients received one-stage percutaneous coronary intervention (PCI) therapy within 12 h.
Exclusion Criteria
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.
18 Years
85 Years
ALL
No
Sponsors
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Alexandria University
OTHER
Damanhour University
OTHER
Responsible Party
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Principal Investigators
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Zeinab M Elhadad, bachelor
Role: PRINCIPAL_INVESTIGATOR
demonstrator of Clinical Pharmacy, Damanhour University.
Amira B Kassem, PhD
Role: STUDY_DIRECTOR
Lecturer of Clinical Pharmacy, Damanhour University.
Ahmed salahaldin, PHD
Role: STUDY_DIRECTOR
Lecturer of biochemisrty, Damanhour University.
noha ahmad, PHD
Role: STUDY_CHAIR
Lecturer of Clinical Pharmacy, Damanhour University.
ahmad alamrawy, PHD
Role: STUDY_CHAIR
Lecturer of cardiology , Faculty of medicine, Alexandria University.
Locations
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Damanhour University
Damanhūr, , Egypt
Countries
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References
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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.
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.
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.
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.
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.
Elhadad ZM, Kassem AB, Amrawy AME, Salahuddin A, El-Bassiouny NA. Comparative Study Between the Effects of High Doses of Rosuvastatin and Atorvastatin on Ventricular Remodeling in Patients with ST-Segment Elevation Myocardial Infarction. Cardiovasc Drugs Ther. 2024 Sep 12. doi: 10.1007/s10557-024-07621-w. Online ahead of print.
Related Links
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Luo R, Sun X, Shen F, Design BH-D, Development undefined, 2020 undefined. Effects of High-Dose Rosuvastatin on Ventricular Remodelling and Cardiac Function in ST-Segment Elevation Myocardial Infarction. ncbi.nlm.nih.gov \[Internet\]. \[cited 2021 Aug 20\];
Other Identifiers
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statinstudy
Identifier Type: -
Identifier Source: org_study_id
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