Status:
RECRUITING
Ezetimibe Utilization Early After Acute Myocardial Infarction, "EzAMI Trial"
Lead Sponsor:
Cairo University
Collaborating Sponsors:
Aswan Heart Centre
Conditions:
Acute Myocardial Infarction
Dyslipidemias
Eligibility:
All Genders
18-100 years
Phase:
NA
Brief Summary
Rationale: Patients with acute coronary syndromes are at an increased risk for recurrent adverse coronary events, particularly during the early period following their initial presentation. Early (in-...
Detailed Description
Introduction: After a major event of "atherosclerotic cardiovascular disease" ASCVD, like a stroke or "Acute Myocardial infarction" AMI, best practice clinical guidelines strongly recommend prompt in...
Eligibility Criteria
Inclusion
- 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
- 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. \[relevant for females in the child-bearing period\]
Key Trial Info
Start Date :
March 24 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT04701242
Start Date
March 24 2021
End Date
December 1 2025
Last Update
August 21 2024
Active Locations (1)
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1
Aswan Heart Centre
Aswān, Egypt, 81511