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

July 31, 2024 updated by: Damanhour University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Damanhūr, Egypt
        • Damanhour University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Rosuvastatin group
patients will receive Rosuvastatin orally (20 mg) at night once daily
Drug: Rosuvastatin 20 mg
patients will receive one tablet rosuvastatin 20 mg every night
Other Names:
  • cholerose
Experimental: Atorvastatin group
patients will receive Atorvastatin orally (40 mg) at night once daily
Drug: Atorvastatin 40mg
patients will receive one tablet Atorvastatin 40 mg every night
Other Names:
  • ator

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Damanhour University

Collaborators

Alexandria University

Investigators

  • Study Director: Amira B Kassem, PhD, Lecturer of Clinical Pharmacy, Damanhour University.
  • Study Chair: noha ahmad, PHD, Lecturer of Clinical Pharmacy, Damanhour University.
  • Principal Investigator: Zeinab M Elhadad, bachelor, demonstrator of Clinical Pharmacy, Damanhour University.
  • Study Director: Ahmed salahaldin, PHD, Lecturer of biochemisrty, Damanhour University.
  • Study Chair: ahmad alamrawy, PHD, Lecturer of cardiology , Faculty of medicine, Alexandria University.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2021

Primary Completion (Actual)

March 1, 2023

Study Completion (Actual)

April 1, 2023

Study Registration Dates

First Submitted

October 11, 2022

First Submitted That Met QC Criteria

June 6, 2023

First Posted (Actual)

June 8, 2023

Study Record Updates

Last Update Posted (Actual)

August 1, 2024

Last Update Submitted That Met QC Criteria

July 31, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • statinstudy

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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