PCSK 9 Inhibitor Added to High-Intensity Statin Therapy to Prevent Cardiovascular Events in Patients With ACS After PCI (ETACS)

This is an interventional treatment trial for Acute Coronary Syndrome Read More

Inclusion Criteria:

• Male or female, age ≥18 y at screening

• Patients with ACS who underwent PCI for culprit lesions. ACS defined as:

  1. Unstable angina, defined as rest pain lasting for 5-30 minutes or deteriorative exertional angina with either a) transient ST segment depression or elevation, or b) angiography showing a visually estimated diameter stenosis ≥90% or a ruptured plaque or thrombotic lesion
  2. Non-ST elevation myocardial infarction (NSTEMI), defined as positive troponin consistent with clinical syndrome and non-ST-segment elevation
  3. ST elevation MI (STEMI), defined as positive troponin consistent with clinical syndrome and ST-segment elevation
• 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 ≥4 wk prior to enrolment; or LDL-C ≥90 mg/dL (≥2.3 mmol/L) in patients who have been on moderate or low intensity statin regimen 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 wk prior to enrollment

• At least one major native coronary artery ("diseased vessels") or lesion meeting the following criteria following the qualifying PCI procedure:

  1. Angiographic evidence of <50% diameter stenosis
  2. Diseased vessel must not be a bypass (saphenous vein or arterial) graft or a bypassed native vessel
  3. Diseased vessel must not have undergone previous PCI prior-to enrollment
• Hemodynamic stability allowing the repetitive administration of nitroglycerine if necessary
• Ability to understand the requirements of the study and to provide informed consent
• Willingness of patient to undergo follow-up procedures and visits

Exclusion Criteria:

• Patients in whom the qualifying index ACS event occurred > 30 days prior to randomization
• Fasting low-density lipoprotein cholesterol (LDL-C) < 70 mg/dL (< 1.8 mmol/L) if on stable statin treatment for minimal 4 weeks; OR LDL-C <90 mg/dL (<2.3 mmol/L) in patients who have been on moderate or low intensity statin regimen 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 wk prior to enrollment
• Fasting serum triglycerides (TG) >400 mg/dL (>4.52 mmol/L) prior to randomization
• History of coronary artery bypass surgery
• Residual diameter stenosis >50% by visual examination after PCI of the culprit lesion
• TIMI flow <2 after culprit vessel PCI
• Unstable clinical status (hemodynamic or electrical instability)
• Uncontrolled hypertension (multiple readings with SBP > 180 mmHg or DBP > 110 mmHg)
• New York Heart Association (NYHA) class III or IV, or last known left ventricular ejection fraction < 30%
• Known history of hemorrhagic stroke less than 180 days prior to randomization
• Uncontrolled cardiac arrhythmia, defined as recurrent and symptomatic ventricular tachycardia or atrial fibrillation with rapid ventricular response not controlled by medications in the past 3 mo prior to screening
• Severe renal dysfunction, defined by estimated glomerular filtration rate <30 ml/min/1.73m^2
• Active liver disease or hepatic dysfunction
• Known intolerance to rosuvastatin OR known statin intolerance
• Known allergy to contrast medium, heparin, aspirin, ticagrelor or prasugrel or clopidogrel
• Patients who previously received PCSK9 inhibitor
• Patient who received cholesterol ester transfer protein inhibitors in the past 12 mo prior to screening
• Treatment with systemic steroids or systemic cyclosporine in the past 3 mo
• Known active infection or major hematologic, metabolic, or endocrine dysfunction in the judgment of the Investigator
• Planned Non-cardiac surgery within 12 mo
• Patients who will not be available for study-required visits in the judgment of the Investigator
• Current enrolment in another investigational device or drug study
• History of cancer within the past 5 y, except for adequately treated basal cell skin cancer, squamous cell skin cancer, or in situ cervical cancer
• Estimated life expectancy less than 12 mo
• Female of childbearing potential (age <50 y and last menstruation within the last 12 mo), who did not undergo tubal ligation, ovariectomy or hysterectomy.