Ezetimibe Utilization Early After Acute Myocardial Infarction, EzAMI Trial

Not Applicable

Recruiting

• Conditions: Acute Myocardial Infarction; Dyslipidemias

• Registration Number: NCT04701242
• Lead Sponsor: Cairo University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-1-6
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

Inclusion Criteria:<br><br> - Age more than 18 years. Both genders are eligible.<br><br> - Acute myocardial infarction (STEMI or NSTEMI) within 48 hours from the onset of<br> symptoms.<br><br> - Baseline LDL-C above 125 mg/dl for those who were not on consistent lipid lowering<br> therapy; or above 100 mg/dl for those who were compliant (= 90 days) on moderate<br> intensity statin therapy.<br><br>Exclusion Criteria:<br><br> - Refusal to participate in the study.<br><br> - Proved intolerance to statins on previous use.<br><br> - Having conditions (or taking medications) that would not allow concomitant safe<br> statins use. [such as patients receiving Cyclosporine - Gemfibrozil -Pazopanib -<br> Tipranavir - Itraconazole - Ketoconazole]<br><br> - Those who are already compliant on high intensity statins.<br><br> - Those who are already on statins plus non-statin agent (ezetimibe-PCSK9i-BAS).<br><br> - Known familial dyslipidemia or having TG>500 mg/dl or LDL-C>190 mg/dl which are<br> highly suggestive of familial or secondary causes.<br><br> - Pregnant or contemplating pregnancy in the following 12 months. [relevant for<br> females in the child-bearing period]

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Efficacy endpoint;(Safety endpoint)

Secondary Outcome Measures

Name	Time	Method
? Percent of LDL-C reduction from baseline to 6 weeks interval.;? Reduction of high-sensitive C-reactive protein (hs-CRP) from baseline to 6 weeks interval.;? MACE free survival at 1 year, (cardiovascular death; non fatal-MI; hospitalization for ACS, urgent unplanned revascularization, and cerebrovascular stroke)