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

NCT05895123 | Completed Phase 2

• 1 other identifier: statinstudy
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Conditions

ST-segment Elevation Myocardial Infarction

Keywords

Statin; remodeling; STEMI

Outcome Measures

Primary Outcomes (1)

• Evaluation of the effect on ventricular remodeling

  MMP9,sST2 and CRP level will be measured and monitoring the change in their levels Echocardiogram will be obtained and monitoring the change in echocardiogram indexes.

  3 months

Secondary Outcomes (1)

• Evaluation of the effect on lipid parameters and liver enzymes

  3 months

Study Arms (2)

Rosuvastatin group

EXPERIMENTAL

patients will receive Rosuvastatin orally (20 mg) at night once daily

Drug: Rosuvastatin 20 mg

Atorvastatin group

EXPERIMENTAL

patients will receive Atorvastatin orally (40 mg) at night once daily

Drug: Atorvastatin 40mg

Interventions

Rosuvastatin 20 mg DRUG

patients will receive one tablet rosuvastatin 20 mg every night

Also known as: cholerose

Rosuvastatin group

Atorvastatin 40mg DRUG

patients will receive one tablet Atorvastatin 40 mg every night

Also known as: ator

Atorvastatin group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Electrocardiogram showed abnormal elevation of the ST segment.
• First myocardial infarction occurred.
• The patients received one-stage percutaneous coronary intervention (PCI) therapy within 12 h.

You may not qualify if:

• Severe cardiac insufficiency.
• Hepatic insufficiency (continuous increase of serum transaminase more than 3 times of the upper limit of normal level).
• Renal insufficiency (creatinine clearance rate \<30 mL/min).
• Addition of others blood lipid lowering and antioxidant drugs during follow up period.
• Familial hypercholesterolemia.
• Malignant tumor.
• Immune system disease.
• Acute infectious disease.
• Hypersensitivity to rosuvastatin and Atorvastatin.

Sponsors & Collaborators

• Damanhour University: lead
• Alexandria University: collaborator

Study Sites (1)

Damanhour University

Damanhūr, Egypt

Location

Related Publications (6)

• 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.

  PMID: 26311995 BACKGROUND

• 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.

  PMID: 10869273 BACKGROUND

• 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.

  PMID: 15638784 BACKGROUND

• 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.

  PMID: 32626540 BACKGROUND

• 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.

  PMID: 28286377 BACKGROUND

• 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. 2025 Oct;39(5):1113-1123. doi: 10.1007/s10557-024-07621-w. Epub 2024 Sep 12.

  PMID: 39264503 DERIVED

Related Links

• 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 \[Internet\]. \[cited 2021 Aug 20\];

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Interventions

Rosuvastatin Calcium; Atorvastatin; ORANGE protein, Arabidopsis

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrroles; Azoles; Heptanoic Acids; Fatty Acids; Lipids

Study Officials

• Zeinab M Elhadad, bachelor

  demonstrator of Clinical Pharmacy, Damanhour University.

  PRINCIPAL INVESTIGATOR

• Amira B Kassem, PhD

  Lecturer of Clinical Pharmacy, Damanhour University.

  STUDY DIRECTOR

• Ahmed salahaldin, PHD

  Lecturer of biochemisrty, Damanhour University.

  STUDY DIRECTOR

• noha ahmad, PHD

  Lecturer of Clinical Pharmacy, Damanhour University.

  STUDY CHAIR

• ahmad alamrawy, PHD

  Lecturer of cardiology , Faculty of medicine, Alexandria University.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized control trial

Study Record Dates

• First Submitted: October 11, 2022
• First Posted: June 8, 2023
• Study Start: November 1, 2021
• Primary Completion: March 1, 2023
• Study Completion: April 1, 2023
• Last Updated: August 1, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)