ST-segment Elevation Myocardial InfarctionPhase 2NCT05895123
Comparison Between the Effects of High Doses Statin on Ventricular Remodeling in STEMI Patients
A Phase 2 study testing Rosuvastatin 20 mg and Atorvastatin 40mg in people with ST-segment Elevation Myocardial Infarction, run by Damanhour University at 1 site in Egypt.
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 . Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- ST-segment Elevation Myocardial Infarction
- What is being tested?
- Rosuvastatin 20 mg and Atorvastatin 40mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2021to 1 Apr 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- Immune system disease.
- Acute infectious disease.
- Hypersensitivity to rosuvastatin and Atorvastatin.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the detailed description
- 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.
- Being tested
- Rosuvastatin 20 mg, Atorvastatin 40mg
- Keywords
- Statin, remodeling, STEMI
- Medical subject headings
- ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rosuvastatin 20 mgDrug
Also called cholerose
patients will receive one tablet rosuvastatin 20 mg every night
Atorvastatin 40mgDrug
Also called ator
patients will receive one tablet Atorvastatin 40 mg every night
| Study group | Role | What they receive |
|---|---|---|
| Rosuvastatin group | Experimental | patients will receive Rosuvastatin orally (20 mg) at night once daily Receives: Drug: Rosuvastatin 20 mg |
| Atorvastatin group | Experimental | patients will receive Atorvastatin orally (40 mg) at night once daily Receives: Drug: Atorvastatin 40mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (1)
Evaluation of the effect on lipid parameters and liver enzymes
lipid parameters and liver enzymes level will be measured and monitoring the change in their levels
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2023
- Study start1 Nov 2021
- Primary completion1 Mar 2023
- Study completion1 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for ST-segment Elevation Myocardial InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized control trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Damanhour University
- Sponsor type
- University, hospital or other
- Collaborators
- Alexandria University
- Responsible party
- Sponsor
- Investigators
- Zeinab M Elhadad, bachelor, Principal investigator, demonstrator of Clinical Pharmacy, Damanhour University.Amira B Kassem, PhD, Study director, Lecturer of Clinical Pharmacy, Damanhour University.Ahmed salahaldin, PHD, Study director, Lecturer of biochemisrty, Damanhour University.noha ahmad, PHD, Study chair, Lecturer of Clinical Pharmacy, Damanhour University.ahmad alamrawy, PHD, Study chair, Lecturer of cardiology , Faculty of medicine, Alexandria University.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05895123
- Sponsor's protocol ID
- statinstudy
- Status last verified
- Jul 2024
- First submitted
- 11 Oct 2022
- Last updated
- 1 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 26311995Sutton 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.
PubMed 10869273Reddy 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.
PubMed 15638784Berezin 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.
PubMed 32626540Neri 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.
PubMed 28286377Elhadad 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.
PubMed 39264503
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between the Effects of High Doses Rosuvastatin and Atorvastatin on Ventricular Remodeling in Patients With ST-Segment Elevation Myocardial Infarction
- ClinicalTrials.gov ID
- NCT05895123
- Acronym / sponsor ID
- statinstudy
- Keywords
- Statin, remodeling, STEMI
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Damanhour UniversityUniversity, hospital or other
- Collaborators
- Alexandria University
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 1 Mar 2023 (actual)
- Study completion
- 1 Apr 2023 (actual)
- First posted
- 8 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized control trial
| Arm | Type | Receives |
|---|---|---|
| Rosuvastatin group | Experimental | Drug: Rosuvastatin 20 mgpatients will receive Rosuvastatin orally (20 mg) at night once daily |
| Atorvastatin group | Experimental | Drug: Atorvastatin 40mgpatients will receive Atorvastatin orally (40 mg) at night once daily |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rosuvastatin 20 mgAlso: cholerosepatients will receive one tablet rosuvastatin 20 mg every night | Drug | Rosuvastatin group |
| Atorvastatin 40mgAlso: atorpatients will receive one tablet Atorvastatin 40 mg every night | Drug | Atorvastatin group |
Primary outcome
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.
1 secondary outcome
Evaluation of the effect on lipid parameters and liver enzymes
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2024.
- Background: PubMed 26311995Khurana 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.
- Background: PubMed 10869273Sutton 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.
- Background: PubMed 15638784Reddy 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.
- Background: PubMed 32626540Berezin 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.
- Background: PubMed 28286377Neri 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.
- Derived from this study: PubMed 39264503Elhadad 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.
- 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 \[Internet\]. \[cited 2021 Aug 20\];Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zeinab M Elhadad, bachelor principal investigator
demonstrator of Clinical Pharmacy, Damanhour University.
Amira B Kassem, PhD study director
Lecturer of Clinical Pharmacy, Damanhour University.
Ahmed salahaldin, PHD study director
Lecturer of biochemisrty, Damanhour University.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Rosuvastatin 20 mg and Atorvastatin 40mg in people with ST-segment Elevation Myocardial Infarction, run by Damanhour University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the effect on ventricular remodeling (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05895123, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2024.