ST Elevation Myocardial InfarctionNCT04974814
Effect of Statin Preloading in STEMI in Improving PCI Outcomes
A study testing Rosuvastatin 40mg and Atorvastatin 80mg in people with ST Elevation Myocardial Infarction, run by Beni-Suef University at 1 site in Egypt.
Trial summary
To compare the effect of a single high dose of atorvastatin versus rosuvastatin preloading on microvascular coronary perfusion as determined by CTFC in patients with ST-segment elevation myocardial infarction (STEMI) undergoing PCI. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- ST Elevation Myocardial Infarction
- What is being tested?
- Rosuvastatin 40mg and Atorvastatin 80mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 99 participants
- Where
- 1 siteEgypt
- Study dates
- 26 May 2021to Apr 2023
- Phase
- Interventional
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The Presence of symptoms (<12h).
- ST-segment elevation of at least 0.1Mv in two contiguous leads of electrocardiogram or new onset left bundle branch block.
- Patients age 18 to 80 years.
Who cannot join
- Previous (within 3 months) or current treatment with statins.
- Known allergy to heparin, aspirin, clopidogrel, or abciximab.
- Active severe bleeding.
- Pregnancy.
- History of major surgery or trauma.
- Significant gastrointestinal or genitourinary bleeding (<6 weeks).
- History of cerebrovascular attack (within 2 years) or cerebrovascular attack with a significant residual neurological deficit.
- Cardiogenic shock with mechanical ventilation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Treatment Efficacy of Rosuvastatin Versus Atorvastatin Loading Prior to Percutaneous Coronary Intervention in ST-Segment Elevation Myocardial Infarction
To compare the effect of a single high dose of atorvastatin versus rosuvastatin preloading on microvascular coronary perfusion as determined by CTFC in patients with ST-segment elevation myocardial infarction (STEMI) undergoing PCI.
Read the detailed description
Acute myocardial infarction (MI) indicates irreversible myocardial injury resulting in necrosis of a significant portion of myocardium which is caused mostly by coronary plaque rupture or erosion. It could result in several clinical complications and impact cardiac prognosis .
Worldwide, ischemic heart disease is the single most common cause of death and its frequency is increasing, now Accounts for almost 1.8 million annual deaths.
Cholesterol reduction with HMG-CoA (3-hydroxy-3-methylglutaryl coenzyme A) reductase inhibitors or statins has been shown to improve mortality and cardiovascular morbidity in patients with established coronary artery disease (CAD).
Previous evidence suggests that statins have various favorable effects on vascular system that are not directly related to their impact on lipid metabolism. Beyond lowering lipids, statins have favorable effects on platelet adhesion, thrombosis, endothelial function, plaque stability, and inflammation. . As with ACS, the vascular injury from coronary angioplasty and stent placement induces platelet activation, thrombosis, and inflammation within the vessel wall and the distal microvasculature. Therefore, in addition to a long-term benefit associated with lipid lowering, statin therapy might play a beneficial role early after PCI.
Conventional TIMI flow grading (Thrombolysis In Myocardial Infarction) is a predictor of cardiac outcome after acute myocardial infarction and PCI, but it has several limitations.
The CTFC (corrected TIMI frame count) another approach to grade flow impairment, is an objective, quantitative, reproducible, and sensitive index for coronary blood flow[9].
TIMI flow may appear normal visually, but may correlate to abnormal CTFC. The CTFC has been proposed to have incremental prognostic accuracy in predicting survival outcome with reperfusion therapy . Higher CTFC values after PCI have also been found to be associated with poor clinical outcomes.
- Conditions
- ST Elevation Myocardial Infarction
- Being tested
- Rosuvastatin 40mg, Atorvastatin 80mg, Control Test
- Keywords
- STEMI, statin, PCI
- 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 40mgDrug
patients in active arms will be preloaded with a single 40 mg rosuvastatin in ER before PCI
Atorvastatin 80mgDrug
patients in active arms will be preloaded with a single 80 mg atorvastatin in ER before PCI
Control TestDrug
patients in control arm will not preloaded with statin in ER before PCI
| Study group | Role | What they receive |
|---|---|---|
| control group | Placebo comparator | in this group patients will not receive statin before primary PCI Receives: Drug: Control Test |
| atorvastatin group | Active comparator | in this group patients will receive 80 mg atorvastatin single dose before primary PCI Receives: Drug: Atorvastatin 80mg |
| rosuvastatin group | Active comparator | in this group patients will receive 40 mg rosuvastatin single dose before primary PCI Receives: Drug: Rosuvastatin 40mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
angiographic parameters
CTFC (corrected TIMI frame count) In the CTFC method, the number of frames required for dye to reach a standardized distal landmark is counted. A correction factor is required to compensate for the longer length of the left anterior descending artery (LAD) compared with the circumflex and right coronary arteries (the number of frames required for dye to traverse the LAD is divided by 1.7). The frame count number after adjustment for vessel length is given the term 'corrected TIMI frame count'.
Measured: 3 months
STR (ST-segment resolution) (STR)
ST-segment resolution (STR) was calculated as the sum of ST-segment elevation on initial ECG minus the sum of ST-segment elevation on the ECG at 90 min after PCI, divided by the sum of ST- segment elevation on initial ECG, and was expressed as a percentage . The complete early STR was defined as more than or equal to 70% STR.
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 posted23 Jul 2021
- Study start26 May 2021
- Primary completionOct 2022 (estimated)
- Study completionApr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for ST Elevation Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by Beni-Suef UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The clinical study will be a prospective open label randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 99 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esraa M. Adel, Beni-Suef University
- Investigators
- Esraa M Adel, bachelor, Principal investigator, National Heart InstituteAhmed A El berry, phd, Study director, Beni-Suef UniversityRaghda R Hussein, phd, Study director, Beni-Suef UniversityAhmed A Abd el hamid, Study director, National Heart Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04974814
- Sponsor's protocol ID
- statin in STEMI
- Status last verified
- Jul 2022
- First submitted
- 6 Jul 2021
- Last updated
- 21 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Elserafy AS, Farag NM, El Desoky AI, Eletriby KA. Effect of high-intensity statin preloading on TIMI flow in patients presenting with ST-elevation myocardial infarction undergoing primary percutaneous coronary intervention. Egypt Heart J. 2020 Jul 10;72(1):40. doi: 10.1186/s43044-020-00074-0.
PubMed 32651772Jang Y, Zhu J, Ge J, Kim YJ, Ji C, Lam W. Preloading with atorvastatin before percutaneous coronary intervention in statin-naive Asian patients with non-ST elevation acute coronary syndromes: A randomized study. J Cardiol. 2014 May;63(5):335-43. doi: 10.1016/j.jjcc.2013.09.012. Epub 2013 Nov 9.
PubMed 24216317Ma M, Bu L, Shi L, Guo R, Yang B, Cao H, Luo L, Lu L. Effect of loading dose of atorvastatin therapy prior to percutaneous coronary intervention in patients with acute coronary syndrome: a meta-analysis of six randomized controlled trials. Drug Des Devel Ther. 2019 Apr 16;13:1233-1240. doi: 10.2147/DDDT.S196588. eCollection 2019.
PubMed 31354240
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Treatment Efficacy of Rosuvastatin Versus Atorvastatin Loading Prior to Percutaneous Coronary Intervention in ST-Segment Elevation Myocardial Infarction
- ClinicalTrials.gov ID
- NCT04974814
- Acronym / sponsor ID
- statin in STEMI
- Conditions
- ST Elevation Myocardial Infarction
- Keywords
- STEMI, statin, PCI
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 99 participants (estimated)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Study start
- 26 May 2021 (actual)
- Primary completion
- Oct 2022 (estimated)
- Study completion
- Apr 2023 (estimated)
- First posted
- 23 Jul 2021 (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.
To compare the effect of a single high dose of atorvastatin versus rosuvastatin preloading on microvascular coronary perfusion as determined by CTFC in patients with ST-segment elevation myocardial infarction (STEMI) undergoing PCI.
Detailed description
Acute myocardial infarction (MI) indicates irreversible myocardial injury resulting in necrosis of a significant portion of myocardium which is caused mostly by coronary plaque rupture or erosion. It could result in several clinical complications and impact cardiac prognosis .
Worldwide, ischemic heart disease is the single most common cause of death and its frequency is increasing, now Accounts for almost 1.8 million annual deaths.
Cholesterol reduction with HMG-CoA (3-hydroxy-3-methylglutaryl coenzyme A) reductase inhibitors or statins has been shown to improve mortality and cardiovascular morbidity in patients with established coronary artery disease (CAD).
Previous evidence suggests that statins have various favorable effects on vascular system that are not directly related to their impact on lipid metabolism. Beyond lowering lipids, statins have favorable effects on platelet adhesion, thrombosis, endothelial function, plaque stability, and inflammation. . As with ACS, the vascular injury from coronary angioplasty and stent placement induces platelet activation, thrombosis, and inflammation within the vessel wall and the distal microvasculature. Therefore, in addition to a long-term benefit associated with lipid lowering, statin therapy might play a beneficial role early after PCI.
Conventional TIMI flow grading (Thrombolysis In Myocardial Infarction) is a predictor of cardiac outcome after acute myocardial infarction and PCI, but it has several limitations.
The CTFC (corrected TIMI frame count) another approach to grade flow impairment, is an objective, quantitative, reproducible, and sensitive index for coronary blood flow[9].
TIMI flow may appear normal visually, but may correlate to abnormal CTFC. The CTFC has been proposed to have incremental prognostic accuracy in predicting survival outcome with reperfusion therapy . Higher CTFC values after PCI have also been found to be associated with poor clinical outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- The clinical study will be a prospective open label randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| control group | Placebo comparator | Drug: Control Testin this group patients will not receive statin before primary PCI |
| atorvastatin group | Active comparator | Drug: Atorvastatin 80mgin this group patients will receive 80 mg atorvastatin single dose before primary PCI |
| rosuvastatin group | Active comparator | Drug: Rosuvastatin 40mgin this group patients will receive 40 mg rosuvastatin single dose before primary PCI |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- The Presence of symptoms (<12h).
- ST-segment elevation of at least 0.1Mv in two contiguous leads of electrocardiogram or new onset left bundle branch block.
- Patients age 18 to 80 years.
Key exclusion criteria (8 listed)
- Previous (within 3 months) or current treatment with statins.
- Known allergy to heparin, aspirin, clopidogrel, or abciximab.
- Active severe bleeding.
- Pregnancy.
- History of major surgery or trauma.
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 40mgpatients in active arms will be preloaded with a single 40 mg rosuvastatin in ER before PCI | Drug | rosuvastatin group |
| Atorvastatin 80mgpatients in active arms will be preloaded with a single 80 mg atorvastatin in ER before PCI | Drug | atorvastatin group |
| Control Testpatients in control arm will not preloaded with statin in ER before PCI | Drug | control group |
Primary outcome
angiographic parameters
Time frame: 3 months
CTFC (corrected TIMI frame count) In the CTFC method, the number of frames required for dye to reach a standardized distal landmark is counted. A correction factor is required to compensate for the longer length of the left anterior descending artery (LAD) compared with the circumflex and right coronary arteries (the number of frames required for dye to traverse the LAD is divided by 1.7). The frame count number after adjustment for vessel length is given the term 'corrected TIMI frame count'.
STR (ST-segment resolution) (STR)
Time frame: 3 months
ST-segment resolution (STR) was calculated as the sum of ST-segment elevation on initial ECG minus the sum of ST-segment elevation on the ECG at 90 min after PCI, divided by the sum of ST- segment elevation on initial ECG, and was expressed as a percentage . The complete early STR was defined as more than or equal to 70% STR.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2022.
- Results publication: PubMed 32651772Elserafy AS, Farag NM, El Desoky AI, Eletriby KA. Effect of high-intensity statin preloading on TIMI flow in patients presenting with ST-elevation myocardial infarction undergoing primary percutaneous coronary intervention. Egypt Heart J. 2020 Jul 10;72(1):40. doi: 10.1186/s43044-020-00074-0.
- Results publication: PubMed 24216317Jang Y, Zhu J, Ge J, Kim YJ, Ji C, Lam W. Preloading with atorvastatin before percutaneous coronary intervention in statin-naive Asian patients with non-ST elevation acute coronary syndromes: A randomized study. J Cardiol. 2014 May;63(5):335-43. doi: 10.1016/j.jjcc.2013.09.012. Epub 2013 Nov 9.
- Results publication: PubMed 31354240Ma M, Bu L, Shi L, Guo R, Yang B, Cao H, Luo L, Lu L. Effect of loading dose of atorvastatin therapy prior to percutaneous coronary intervention in patients with acute coronary syndrome: a meta-analysis of six randomized controlled trials. Drug Des Devel Ther. 2019 Apr 16;13:1233-1240. doi: 10.2147/DDDT.S196588. eCollection 2019.
- 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.
Esraa M Adel, bachelor principal investigator
National Heart Institute
Ahmed A El berry, phd study director
Beni-Suef University
Raghda R Hussein, phd study director
Beni-Suef University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rosuvastatin 40mg and Atorvastatin 80mg in people with ST Elevation Myocardial Infarction, run by Beni-Suef 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 8 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: status not confirmed, as of the sponsor's last update on 21 Jul 2022. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Esraa M Adel, bachelor (01026 028251, esso_935@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
angiographic parameters (time frame: 3 months). The study lists 2 primary outcomes in all. 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 NCT04974814, which also lists 3 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 21 Jul 2022.