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Completed

NCT Number: NCT05895123

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

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

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Key information

Conditions

ST-segment Elevation Myocardial Infarction Cardiovascular Diseases Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms ST Elevation Myocardial Infarction Vascular Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Damanhour University

Damanhūr, Egypt

About this study

  • Ethical committee approval will be obtained from Ethics committee of Faculty of Pharmacy, Damanhour University.
  • All participants should agree to take part in this clinical study and will provide informed consent.
  • (80) patients diagnosed with STEMI will be enrolled from Alexandria university hospital.
  • Serum samples will be collected from patients at the time of admission for measuring the biomarkers.
  • Echocardiogram also will be obtained at the time of admission.
  • All enrolled patients will be divided into two group to receive either Atorvastatin (40 mg) or Rosuvastatin (20mg).
  • 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.
  • Statistical tests appropriate to the study design will be conducted to evaluate the significance of the results.
  • Results, conclusion, discussion, and recommendations will be given.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Rosuvastatin 20 mg

Drug

patients will receive one tablet rosuvastatin 20 mg every night

Other names: cholerose

Atorvastatin 40mg

Drug

patients will receive one tablet Atorvastatin 40 mg every night

Other names: ator

Primary outcomes

  1. Evaluation of the effect on ventricular remodeling

    Time frame: 3 months

    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.

Secondary outcomes

  1. Evaluation of the effect on lipid parameters and liver enzymes

    Time frame: 3 months

    lipid parameters and liver enzymes level will be measured and monitoring the change in their levels

Sponsors and collaborators

Lead sponsor

Damanhour University

Other

Collaborators

  • Alexandria University

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jun 8, 2023
Registry last updated
Aug 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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