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

ST-segment Elevation Myocardial Infarction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05895123
• Other study ID #: statinstudy
• Status: Completed
• Phase: Phase 2
• Start date: October 1, 2022
• Est. completion date: April 1, 2023

Study information

• Verified date: June 2023
• Source: Damanhour University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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 (40-80 mg) or Rosuvastatin (20-40mg).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: April 1, 2023
• Est. primary completion date: March 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction
• ST Elevation Myocardial Infarction
• ST-segment Elevation Myocardial Infarction
• Ventricular Remodeling

Intervention

Drug:
• Rosuvastatin 20 mg ,40 mg
patients will receive one tablet rosuvastatin 20-40 mg every night
• Atorvastatin 40mg,80mg
patients will receive one tablet Atorvastatin 20-40 mg every night

Locations

Country	Name	City	State
Egypt	Damanhour University	Damanhur

Sponsors (2)

Lead Sponsor	Collaborator
Damanhour University	Alexandria University

Country where clinical trial is conducted

Egypt, 

References & Publications (5)

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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of the effect on ventricular remodeling	Echocardiogram will be obtained and monitoring the change in echocardiogram indexes.	3 months

External Links

•   Bostan M, Statescu C, Anghel L, Biomolecules I ?erban-, 2020 undefined. PostMyocardial Infarction Ventricular Remodeling Biomarkers-The Key Link between Pathophysiology and Clinic. mdpi.com [Internet]. [cited 2021 Aug 22];
•   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];
•   Wegiel M, Interwencyjnej TR-P w K, 2021 undefined. Circulating biomarkers as predictors of left ventricular remodeling after myocardial infarction. ncbi.nlm.nih.gov [Internet]. [cited 2021 Sep 8];