Effects of Alirocumab on coronary plaque formation in patients with acute heart infarct. A serial, multivessel imaging study.

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 294

Inclusion Criteria

Acute myocardial infarction: acute ST-segment elevation myocardial infarction (STEMI) with pain onset within =24h, or non-ST segment elevation myocardial infarction (NSTEMI), with at least one coronary segment (culprit lesion) requiring PCI;
LDL-C =70 mg/dL (=1.8 mmol/L) assessed prior to, or during PCI in patients who have been receiving any stable statin regimen within = 4 weeks prior to enrollment; OR LDL-C =125 mg/dL (=3.2 mmol/L) in patients who are statin-naïve or have not been on stable statin regimen
for = 4 weeks prior to enrollment;
At least two major native coronary arteries (target vessels) each meeting the following criteria for intracoronary imaging immediately following the qualifying PCI procedure;
Hemodynamic stability allowing the repetitive administration of nitroglycerine;
Ability to understand the requirements of the study and to provide informed consent;
Willingness to undergo follow-up intracoronary imaging

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 168
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 126

Exclusion Criteria

Left-main disease, defined as =50% reduction in lumen diameter of the left main coronary artery by angiographic visual estimation;
Three-vessel disease;
History of coronary artery bypass surgery;
TIMI flow <2 of the infarct-related artery after PCI;
Unstable clinical status (hemodynamic or electrical instability);
Significant coronary calcification or tortuosity deemed to preclude IVUS, NIRS and OCT evaluation;
Uncontrolled cardiac arrhythmia;
Severe renal dysfunction;
Active liver disease or hepatic dysfunction;
Known intolerance to rosuvastatin OR known statin intolerance ;
Known allergy to contrast medium, heparin, aspirin, ticagrelor or prasugrel;
Known sensitivity to any substances to be administered, including known statin intolerance
Patients who previously received alirocumab or other PCSK9 inhibitor;
Patient who received cholesterol ester transfer protein inhibitors in the
past 12 months prior to screening; Treatment with systemic steroids or
systemic cyclosporine in the past 3 months;
Known active infection or major hematologic, metabolic, or endocrine
dysfunction;
Planned surgery within 12 months;
Patients who will not be available for study-required visits;
Current enrollment in another investigational device or drug study;
History of cancer within the past 5 years, except for adequately treated
basal cell skin cancer, squamous cell skin cancer, or in situ cervical
cancer;
Estimated life expectancy less than 1 year;
Female of childbearing potential (age <50 years and last menstruation
within the last 12 months), who did not undergo tubal ligation,
ovariectomy or hysterectomy.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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