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Ezetimibe Utilization Early After Acute Myocardial Infarction, "EzAMI Trial"

RecruitingNAAges 18 Years - 100 YearsAllCairo University
NCT04701242 on ClinicalTrials.gov โ†—
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In plain words

What the trial is, and whether it could suit you

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-hospital) initiation of high-intensity statins reduces the risk of recurrent events and is therefore recommended by the best current practice guidelines.(1,2) However, the delayed onset of action of statin therapy and given the frequent failure of patients to achieve the recommended LDL-C targets using statins alone (as per the current practice guidelines recommendations), might be placing large number of patients at increased risk during such a vulnerable period early after an ACS.(3) More rapid and effective reduction of LDL-C levels using combination therapy from the outset may therefore be beneficial in these patients. This hypothesis has been tested with combining Evolocumab and a stati

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๐Ÿ“‹ Eligibility rules (as published)
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 (โ‰ฅ 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. \[relevant for females in the child-bearing period\]
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What it tests

  • Ezetimibe 10mg
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Where

1 site
Aswan Heart Centre
Aswฤn, Egypt
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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