Status:
COMPLETED
EVOlocumab for Early Reduction of LDL-cholesterol Levels in Patients With Acute Coronary Syndromes (EVOPACS)
Lead Sponsor:
Insel Gruppe AG, University Hospital Bern
Collaborating Sponsors:
Amgen
University of Bern
Conditions:
Acute Coronary Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Reduction of low-density lipoprotein cholesterol (LDL-C) levels effectively reduces the risk of adverse events in patients with established atherosclerotic cardiovascular disease. The clinical benefit...
Eligibility Criteria
Inclusion
- Male or female ≥ 18 years of age;
- Hospitalized for a recent ACS;
- LDL-C levels defined as follows:
- LDL-C ≥70 mg/dL (≥1.8 mmol/L) or non-HDL-C ≥100 mg/dL (≥2.6 mmol/) in patients who have been receiving stable treatment with high-intensity statin within ≥ 4 weeks prior to enrollment (i.e. continuous treatment that has not changed with regard to statin intensity over the past 4 weeks) or, LDL-C ≥90 mg/dL (≥2.3 mmol/L) or non-HDL-C ≥120 mg/dL (≥3.1 mmol/) in patients who have been receiving stable treatment with low- or moderate-intensity statin within ≥ 4 weeks prior to enrollment (i.e. continuous treatment that has not changed with regard to statin intensity over the past 4 weeks), or LDL-C ≥125 mg/dL (≥3.2 mmol/L) or non-HDL-C ≥155 mg/dL (≥4.0 mmol/) in patients who are statin-naïve or have not been on a stable (unchanged) statin regimen for at least 4 weeks prior to enrollment;
- Ability to understand the requirements of the study and to provide informed consent.
Exclusion
- Unstable clinical status (hemodynamic or electrical instability;
- 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 months prior to screening;
- Severe renal dysfunction, defined by estimated glomerular filtration rate \<30 ml/min/1.73m2;
- Active liver disease or hepatic dysfunction, either reported in patient medical record or defined by asparate aminotransferase (AST) or alanine aminotransferase (ALT) levels \> 3x the upper limit of normal;
- Reported intolerance to atorvastatin (any dose) OR statin intolerance;
- Known allergy to contrast medium, heparin, aspirin, ticagrelor or prasugrel;
- Known sensitivity to any substances to be administered;
- Patients who previously received evolocumab 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 systemic cyclosporine, systemic steroids (eg. intravenous, intramuscular or per os);
- Known active infection or major hematologic, metabolic, or endocrine dysfunction in the judgment of the Investigator;
- Patients who will not be available for study-required procedures in the judgment of the Investigator;
- Current enrollment in another investigational device or drug study;
- Active malignancy requiring treatment;
- Female of childbearing potential (age \<50 years and last menstruation within the last 12 months), who did not undergo tubal ligation, ovariectomy or hysterectomy.
Key Trial Info
Start Date :
January 23 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 7 2019
Estimated Enrollment :
308 Patients enrolled
Trial Details
Trial ID
NCT03287609
Start Date
January 23 2018
End Date
August 7 2019
Last Update
August 14 2019
Active Locations (7)
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1
Basel University Hospital
Basel, Canton of Basel-City, Switzerland, 4031
2
HFR Kantonsspital
Fribourg, Canton of Fribourg, Switzerland, 1708
3
Hopitaux Universitaires Geneve
Geneva, Canton of Geneva, Switzerland, 1211
4
Centre Hospitalier Universitaire Vaudois
Lausanne, Canton of Vaud, Switzerland