Using Ezetimibe After Heart Attacks
Ezetimibe Utilization Early After Acute Myocardial Infarction. "EzAMI Trial"
This study tests if starting a cholesterol-lowering drug called Ezetimibe right after a heart attack can help people lower their bad cholesterol and prevent future heart problems when used with statins.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 500 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | Cairo University Academic / other |
| Drugs / interventions | Evolocumab |
| Locations | 1 site (Aswān) |
| Trial ID | NCT04701242 on ClinicalTrials.gov |
What this trial studies
This trial investigates the early use of Ezetimibe, a cholesterol-lowering medication, in patients who have experienced an acute myocardial infarction (heart attack). The study aims to determine if initiating Ezetimibe alongside high-intensity statin therapy can more effectively lower LDL cholesterol levels and reduce the risk of recurrent heart events. Patients will be monitored for their LDL-C levels and overall cardiovascular health following the intervention. The trial focuses on individuals who have not achieved target cholesterol levels with statins alone.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 who have had a heart attack within the last 48 hours and have elevated LDL-C levels.
Not a fit: Patients who are already on high-intensity statins or have proven intolerance to statins may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly lower the risk of further heart complications in patients recovering from a heart attack.
How similar studies have performed: Previous studies have shown promise in using combination therapies for cholesterol management after acute coronary events, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age more than 18 years. Both genders are eligible. * Acute myocardial infarction (STEMI or NSTEMI) within 48 hours from the onset of symptoms. * Baseline LDL-C above 125 mg/dl for those who were not on consistent lipid lowering therapy; or above 100 mg/dl for those who were compliant (≥ 90 days) on moderate intensity statin therapy. Exclusion Criteria: * Refusal to participate in the study. * Proved intolerance to statins on previous use. * Having conditions (or taking medications) that would not allow concomitant safe statins use. \[such as patients receiving Cyclosporine - Gemfibrozil -Pazopanib - Tipranavir - Itraconazole - Ketoconazole\] * Those who are already compliant on high intensity statins. * Those who are already on statins plus non-statin agent (ezetimibe-PCSK9i-BAS). * Known familial dyslipidemia or having TG\>500 mg/dl or LDL-C\>190 mg/dl which are highly suggestive of familial or secondary causes. * Pregnant or contemplating pregnancy in the following 12 months. \[relevant for females in the child-bearing period\]
Where this trial is running
Aswān
- Aswan Heart Centre — Aswān, Egypt (Recruiting)
Study contacts
- Principal investigator: Ahmad Samir, MD — Cairo University
- Study coordinator: Ahmad Samir, MD
- Email: ahmad.samir@kasralainy.edu.eg
- Phone: 00201002647275
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.