title: Safety and Tolerability of CSL112, a Reconstituted, Infusible, Plasma-Derived Apolipoprotein A-I, After Acute Myocardial Infarction: The AEGIS-I Trial (ApoA-I Event Reducing in Ischemic Syndromes I).
abstract: BACKGROUND
  Human or recombinant apolipoprotein A-I (apoA-I) has been shown to increase high-density lipoprotein-mediated cholesterol efflux capacity and to regress atherosclerotic disease in animal and clinical studies. CSL112 is an infusible, plasma-derived apoA-I that has been studied in normal subjects or those with stable coronary artery disease. This study aimed to characterize the safety, tolerability, pharmacokinetics, and pharmacodynamics of CSL112 in patients with a recent acute myocardial infarction.
  
  
  METHODS
  The AEGIS-I trial (Apo-I Event Reducing in Ischemic Syndromes I) was a multicenter, randomized, double-blind, placebo-controlled, dose-ranging phase 2b trial. Patients with myocardial infarction were stratified by renal function and randomized 1:1:1 to CSL112 (2 g apoA-I per dose) and high-dose CSL112 (6 g apoA-I per dose), or placebo for 4 consecutive weekly infusions. Coprimary safety end points were occurrence of either a hepatic safety event (an increase in alanine transaminase >3 times the upper limit of normal or an increase in total bilirubin >2 times the upper limit of normal) or a renal safety event (an increase in serum creatinine >1.5 times the baseline value or a new requirement for renal replacement therapy).
  
  
  RESULTS
  A total of 1258 patients were randomized, and 91.2% received all 4 infusions. The difference in incidence rates for an increase in alanine transaminase or total bilirubin between both CSL112 arms and placebo was within the protocol-defined noninferiority margin of 4%. Similarly, the difference in incidence rates for an increase in serum creatinine or a new requirement for renal replacement therapy was within the protocol-defined noninferiority margin of 5%. CSL112 was associated with increases in apoA-I and ex vivo cholesterol efflux similar to that achieved in patients with stable coronary artery disease. In regard to the secondary efficacy end point, the risk for the composite of major adverse cardiovascular events among the groups was similar.
  
  
  CONCLUSIONS
  Among patients with acute myocardial infarction, 4 weekly infusions of CSL112 are feasible, well tolerated, and not associated with any significant alterations in liver or kidney function or other safety concern. The ability of CSL112 to acutely enhance cholesterol efflux was confirmed. The potential benefit of CSL112 to reduce major adverse cardiovascular events needs to be assessed in an adequately powered phase 3 trial.
  
  
  BACKGROUND
  URL: https://clinicaltrials.gov. Unique identifier: NCT02108262.
authors.affiliation: From PERFUSE Study Group, Cardiovascular Division, Department of Medicine, Beth Israel Deaconess Medical, Harvard Medical School, Boston, MA (C.M.G., S.K., Y.D., M.Y., P.J.); Duke Clinical Research Institute, Cardiovascular Division, Department of Medicine, Duke University Health, Durham, NC (P.T., J.H.A.); INSERM-Unité 1148, France Assistance Publique-Hôpitaux de Paris, Hôpital Bichat, France Université Paris-Diderot, Sorbonne- Paris Cité, France National Heart and Lung Institute, Paris, France (P.G.S.); Imperial College London, UK Institute of Cardiovascular Medicine and Science, and Royal Brompton Hospital, London, UK (P.G.S.); Department of Cardiovascular Medicine, Cleveland Clinic Foundation, Cleveland, OH (A.M.L.); Department of Vascular Medicine, Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands (J.J.P.K.); Cardiovascular Institute, Mount Sinai Medical Center, Icahn School of Medicine at Mount Sinai, New York (R.M.); CSL Behring, LLC, King of Prussia, PA (D.M.D., L.I.D.); Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.M.); Department of Cardiology, Warsaw Medical University, Warsaw, Poland (M.Z.); Department of Cardiology, Canisius Wilhelmina Ziekenhuis, Nijmegen, the Netherlands (T.O.O.); and Department of Medicine, Stanford University, Stanford, CA (R.A.H.). mgibson@bidmc.harvard.edu.
authors.forename: C
authors.initials: C
authors.lastname: Michael Gibson
authors.affiliation: From PERFUSE Study Group, Cardiovascular Division, Department of Medicine, Beth Israel Deaconess Medical, Harvard Medical School, Boston, MA (C.M.G., S.K., Y.D., M.Y., P.J.); Duke Clinical Research Institute, Cardiovascular Division, Department of Medicine, Duke University Health, Durham, NC (P.T., J.H.A.); INSERM-Unité 1148, France Assistance Publique-Hôpitaux de Paris, Hôpital Bichat, France Université Paris-Diderot, Sorbonne- Paris Cité, France National Heart and Lung Institute, Paris, France (P.G.S.); Imperial College London, UK Institute of Cardiovascular Medicine and Science, and Royal Brompton Hospital, London, UK (P.G.S.); Department of Cardiovascular Medicine, Cleveland Clinic Foundation, Cleveland, OH (A.M.L.); Department of Vascular Medicine, Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands (J.J.P.K.); Cardiovascular Institute, Mount Sinai Medical Center, Icahn School of Medicine at Mount Sinai, New York (R.M.); CSL Behring, LLC, King of Prussia, PA (D.M.D., L.I.D.); Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.M.); Department of Cardiology, Warsaw Medical University, Warsaw, Poland (M.Z.); Department of Cardiology, Canisius Wilhelmina Ziekenhuis, Nijmegen, the Netherlands (T.O.O.); and Department of Medicine, Stanford University, Stanford, CA (R.A.H.).
authors.forename: Serge
authors.initials: S
authors.lastname: Korjian
authors.affiliation: From PERFUSE Study Group, Cardiovascular Division, Department of Medicine, Beth Israel Deaconess Medical, Harvard Medical School, Boston, MA (C.M.G., S.K., Y.D., M.Y., P.J.); Duke Clinical Research Institute, Cardiovascular Division, Department of Medicine, Duke University Health, Durham, NC (P.T., J.H.A.); INSERM-Unité 1148, France Assistance Publique-Hôpitaux de Paris, Hôpital Bichat, France Université Paris-Diderot, Sorbonne- Paris Cité, France National Heart and Lung Institute, Paris, France (P.G.S.); Imperial College London, UK Institute of Cardiovascular Medicine and Science, and Royal Brompton Hospital, London, UK (P.G.S.); Department of Cardiovascular Medicine, Cleveland Clinic Foundation, Cleveland, OH (A.M.L.); Department of Vascular Medicine, Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands (J.J.P.K.); Cardiovascular Institute, Mount Sinai Medical Center, Icahn School of Medicine at Mount Sinai, New York (R.M.); CSL Behring, LLC, King of Prussia, PA (D.M.D., L.I.D.); Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.M.); Department of Cardiology, Warsaw Medical University, Warsaw, Poland (M.Z.); Department of Cardiology, Canisius Wilhelmina Ziekenhuis, Nijmegen, the Netherlands (T.O.O.); and Department of Medicine, Stanford University, Stanford, CA (R.A.H.).
authors.forename: Pierluigi
authors.initials: P
authors.lastname: Tricoci
authors.affiliation: From PERFUSE Study Group, Cardiovascular Division, Department of Medicine, Beth Israel Deaconess Medical, Harvard Medical School, Boston, MA (C.M.G., S.K., Y.D., M.Y., P.J.); Duke Clinical Research Institute, Cardiovascular Division, Department of Medicine, Duke University Health, Durham, NC (P.T., J.H.A.); INSERM-Unité 1148, France Assistance Publique-Hôpitaux de Paris, Hôpital Bichat, France Université Paris-Diderot, Sorbonne- Paris Cité, France National Heart and Lung Institute, Paris, France (P.G.S.); Imperial College London, UK Institute of Cardiovascular Medicine and Science, and Royal Brompton Hospital, London, UK (P.G.S.); Department of Cardiovascular Medicine, Cleveland Clinic Foundation, Cleveland, OH (A.M.L.); Department of Vascular Medicine, Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands (J.J.P.K.); Cardiovascular Institute, Mount Sinai Medical Center, Icahn School of Medicine at Mount Sinai, New York (R.M.); CSL Behring, LLC, King of Prussia, PA (D.M.D., L.I.D.); Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.M.); Department of Cardiology, Warsaw Medical University, Warsaw, Poland (M.Z.); Department of Cardiology, Canisius Wilhelmina Ziekenhuis, Nijmegen, the Netherlands (T.O.O.); and Department of Medicine, Stanford University, Stanford, CA (R.A.H.).
authors.forename: Yazan
authors.initials: Y
authors.lastname: Daaboul
authors.affiliation: From PERFUSE Study Group, Cardiovascular Division, Department of Medicine, Beth Israel Deaconess Medical, Harvard Medical School, Boston, MA (C.M.G., S.K., Y.D., M.Y., P.J.); Duke Clinical Research Institute, Cardiovascular Division, Department of Medicine, Duke University Health, Durham, NC (P.T., J.H.A.); INSERM-Unité 1148, France Assistance Publique-Hôpitaux de Paris, Hôpital Bichat, France Université Paris-Diderot, Sorbonne- Paris Cité, France National Heart and Lung Institute, Paris, France (P.G.S.); Imperial College London, UK Institute of Cardiovascular Medicine and Science, and Royal Brompton Hospital, London, UK (P.G.S.); Department of Cardiovascular Medicine, Cleveland Clinic Foundation, Cleveland, OH (A.M.L.); Department of Vascular Medicine, Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands (J.J.P.K.); Cardiovascular Institute, Mount Sinai Medical Center, Icahn School of Medicine at Mount Sinai, New York (R.M.); CSL Behring, LLC, King of Prussia, PA (D.M.D., L.I.D.); Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.M.); Department of Cardiology, Warsaw Medical University, Warsaw, Poland (M.Z.); Department of Cardiology, Canisius Wilhelmina Ziekenhuis, Nijmegen, the Netherlands (T.O.O.); and Department of Medicine, Stanford University, Stanford, CA (R.A.H.).
authors.forename: Megan
authors.initials: M
authors.lastname: Yee
authors.affiliation: From PERFUSE Study Group, Cardiovascular Division, Department of Medicine, Beth Israel Deaconess Medical, Harvard Medical School, Boston, MA (C.M.G., S.K., Y.D., M.Y., P.J.); Duke Clinical Research Institute, Cardiovascular Division, Department of Medicine, Duke University Health, Durham, NC (P.T., J.H.A.); INSERM-Unité 1148, France Assistance Publique-Hôpitaux de Paris, Hôpital Bichat, France Université Paris-Diderot, Sorbonne- Paris Cité, France National Heart and Lung Institute, Paris, France (P.G.S.); Imperial College London, UK Institute of Cardiovascular Medicine and Science, and Royal Brompton Hospital, London, UK (P.G.S.); Department of Cardiovascular Medicine, Cleveland Clinic Foundation, Cleveland, OH (A.M.L.); Department of Vascular Medicine, Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands (J.J.P.K.); Cardiovascular Institute, Mount Sinai Medical Center, Icahn School of Medicine at Mount Sinai, New York (R.M.); CSL Behring, LLC, King of Prussia, PA (D.M.D., L.I.D.); Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.M.); Department of Cardiology, Warsaw Medical University, Warsaw, Poland (M.Z.); Department of Cardiology, Canisius Wilhelmina Ziekenhuis, Nijmegen, the Netherlands (T.O.O.); and Department of Medicine, Stanford University, Stanford, CA (R.A.H.).
authors.forename: Purva
authors.initials: P
authors.lastname: Jain
authors.affiliation: From PERFUSE Study Group, Cardiovascular Division, Department of Medicine, Beth Israel Deaconess Medical, Harvard Medical School, Boston, MA (C.M.G., S.K., Y.D., M.Y., P.J.); Duke Clinical Research Institute, Cardiovascular Division, Department of Medicine, Duke University Health, Durham, NC (P.T., J.H.A.); INSERM-Unité 1148, France Assistance Publique-Hôpitaux de Paris, Hôpital Bichat, France Université Paris-Diderot, Sorbonne- Paris Cité, France National Heart and Lung Institute, Paris, France (P.G.S.); Imperial College London, UK Institute of Cardiovascular Medicine and Science, and Royal Brompton Hospital, London, UK (P.G.S.); Department of Cardiovascular Medicine, Cleveland Clinic Foundation, Cleveland, OH (A.M.L.); Department of Vascular Medicine, Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands (J.J.P.K.); Cardiovascular Institute, Mount Sinai Medical Center, Icahn School of Medicine at Mount Sinai, New York (R.M.); CSL Behring, LLC, King of Prussia, PA (D.M.D., L.I.D.); Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.M.); Department of Cardiology, Warsaw Medical University, Warsaw, Poland (M.Z.); Department of Cardiology, Canisius Wilhelmina Ziekenhuis, Nijmegen, the Netherlands (T.O.O.); and Department of Medicine, Stanford University, Stanford, CA (R.A.H.).
authors.forename: John H
authors.initials: JH
authors.lastname: Alexander
authors.affiliation: From PERFUSE Study Group, Cardiovascular Division, Department of Medicine, Beth Israel Deaconess Medical, Harvard Medical School, Boston, MA (C.M.G., S.K., Y.D., M.Y., P.J.); Duke Clinical Research Institute, Cardiovascular Division, Department of Medicine, Duke University Health, Durham, NC (P.T., J.H.A.); INSERM-Unité 1148, France Assistance Publique-Hôpitaux de Paris, Hôpital Bichat, France Université Paris-Diderot, Sorbonne- Paris Cité, France National Heart and Lung Institute, Paris, France (P.G.S.); Imperial College London, UK Institute of Cardiovascular Medicine and Science, and Royal Brompton Hospital, London, UK (P.G.S.); Department of Cardiovascular Medicine, Cleveland Clinic Foundation, Cleveland, OH (A.M.L.); Department of Vascular Medicine, Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands (J.J.P.K.); Cardiovascular Institute, Mount Sinai Medical Center, Icahn School of Medicine at Mount Sinai, New York (R.M.); CSL Behring, LLC, King of Prussia, PA (D.M.D., L.I.D.); Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.M.); Department of Cardiology, Warsaw Medical University, Warsaw, Poland (M.Z.); Department of Cardiology, Canisius Wilhelmina Ziekenhuis, Nijmegen, the Netherlands (T.O.O.); and Department of Medicine, Stanford University, Stanford, CA (R.A.H.).
authors.forename: P Gabriel
authors.initials: PG
authors.lastname: Steg
authors.affiliation: From PERFUSE Study Group, Cardiovascular Division, Department of Medicine, Beth Israel Deaconess Medical, Harvard Medical School, Boston, MA (C.M.G., S.K., Y.D., M.Y., P.J.); Duke Clinical Research Institute, Cardiovascular Division, Department of Medicine, Duke University Health, Durham, NC (P.T., J.H.A.); INSERM-Unité 1148, France Assistance Publique-Hôpitaux de Paris, Hôpital Bichat, France Université Paris-Diderot, Sorbonne- Paris Cité, France National Heart and Lung Institute, Paris, France (P.G.S.); Imperial College London, UK Institute of Cardiovascular Medicine and Science, and Royal Brompton Hospital, London, UK (P.G.S.); Department of Cardiovascular Medicine, Cleveland Clinic Foundation, Cleveland, OH (A.M.L.); Department of Vascular Medicine, Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands (J.J.P.K.); Cardiovascular Institute, Mount Sinai Medical Center, Icahn School of Medicine at Mount Sinai, New York (R.M.); CSL Behring, LLC, King of Prussia, PA (D.M.D., L.I.D.); Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.M.); Department of Cardiology, Warsaw Medical University, Warsaw, Poland (M.Z.); Department of Cardiology, Canisius Wilhelmina Ziekenhuis, Nijmegen, the Netherlands (T.O.O.); and Department of Medicine, Stanford University, Stanford, CA (R.A.H.).
authors.forename: A Michael
authors.initials: AM
authors.lastname: Lincoff
authors.affiliation: From PERFUSE Study Group, Cardiovascular Division, Department of Medicine, Beth Israel Deaconess Medical, Harvard Medical School, Boston, MA (C.M.G., S.K., Y.D., M.Y., P.J.); Duke Clinical Research Institute, Cardiovascular Division, Department of Medicine, Duke University Health, Durham, NC (P.T., J.H.A.); INSERM-Unité 1148, France Assistance Publique-Hôpitaux de Paris, Hôpital Bichat, France Université Paris-Diderot, Sorbonne- Paris Cité, France National Heart and Lung Institute, Paris, France (P.G.S.); Imperial College London, UK Institute of Cardiovascular Medicine and Science, and Royal Brompton Hospital, London, UK (P.G.S.); Department of Cardiovascular Medicine, Cleveland Clinic Foundation, Cleveland, OH (A.M.L.); Department of Vascular Medicine, Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands (J.J.P.K.); Cardiovascular Institute, Mount Sinai Medical Center, Icahn School of Medicine at Mount Sinai, New York (R.M.); CSL Behring, LLC, King of Prussia, PA (D.M.D., L.I.D.); Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.M.); Department of Cardiology, Warsaw Medical University, Warsaw, Poland (M.Z.); Department of Cardiology, Canisius Wilhelmina Ziekenhuis, Nijmegen, the Netherlands (T.O.O.); and Department of Medicine, Stanford University, Stanford, CA (R.A.H.).
authors.forename: John J P
authors.initials: JJ
authors.lastname: Kastelein
authors.affiliation: From PERFUSE Study Group, Cardiovascular Division, Department of Medicine, Beth Israel Deaconess Medical, Harvard Medical School, Boston, MA (C.M.G., S.K., Y.D., M.Y., P.J.); Duke Clinical Research Institute, Cardiovascular Division, Department of Medicine, Duke University Health, Durham, NC (P.T., J.H.A.); INSERM-Unité 1148, France Assistance Publique-Hôpitaux de Paris, Hôpital Bichat, France Université Paris-Diderot, Sorbonne- Paris Cité, France National Heart and Lung Institute, Paris, France (P.G.S.); Imperial College London, UK Institute of Cardiovascular Medicine and Science, and Royal Brompton Hospital, London, UK (P.G.S.); Department of Cardiovascular Medicine, Cleveland Clinic Foundation, Cleveland, OH (A.M.L.); Department of Vascular Medicine, Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands (J.J.P.K.); Cardiovascular Institute, Mount Sinai Medical Center, Icahn School of Medicine at Mount Sinai, New York (R.M.); CSL Behring, LLC, King of Prussia, PA (D.M.D., L.I.D.); Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.M.); Department of Cardiology, Warsaw Medical University, Warsaw, Poland (M.Z.); Department of Cardiology, Canisius Wilhelmina Ziekenhuis, Nijmegen, the Netherlands (T.O.O.); and Department of Medicine, Stanford University, Stanford, CA (R.A.H.).
authors.forename: Roxana
authors.initials: R
authors.lastname: Mehran
authors.affiliation: From PERFUSE Study Group, Cardiovascular Division, Department of Medicine, Beth Israel Deaconess Medical, Harvard Medical School, Boston, MA (C.M.G., S.K., Y.D., M.Y., P.J.); Duke Clinical Research Institute, Cardiovascular Division, Department of Medicine, Duke University Health, Durham, NC (P.T., J.H.A.); INSERM-Unité 1148, France Assistance Publique-Hôpitaux de Paris, Hôpital Bichat, France Université Paris-Diderot, Sorbonne- Paris Cité, France National Heart and Lung Institute, Paris, France (P.G.S.); Imperial College London, UK Institute of Cardiovascular Medicine and Science, and Royal Brompton Hospital, London, UK (P.G.S.); Department of Cardiovascular Medicine, Cleveland Clinic Foundation, Cleveland, OH (A.M.L.); Department of Vascular Medicine, Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands (J.J.P.K.); Cardiovascular Institute, Mount Sinai Medical Center, Icahn School of Medicine at Mount Sinai, New York (R.M.); CSL Behring, LLC, King of Prussia, PA (D.M.D., L.I.D.); Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.M.); Department of Cardiology, Warsaw Medical University, Warsaw, Poland (M.Z.); Department of Cardiology, Canisius Wilhelmina Ziekenhuis, Nijmegen, the Netherlands (T.O.O.); and Department of Medicine, Stanford University, Stanford, CA (R.A.H.).
authors.forename: Denise M
authors.initials: DM
authors.lastname: D'Andrea
authors.affiliation: From PERFUSE Study Group, Cardiovascular Division, Department of Medicine, Beth Israel Deaconess Medical, Harvard Medical School, Boston, MA (C.M.G., S.K., Y.D., M.Y., P.J.); Duke Clinical Research Institute, Cardiovascular Division, Department of Medicine, Duke University Health, Durham, NC (P.T., J.H.A.); INSERM-Unité 1148, France Assistance Publique-Hôpitaux de Paris, Hôpital Bichat, France Université Paris-Diderot, Sorbonne- Paris Cité, France National Heart and Lung Institute, Paris, France (P.G.S.); Imperial College London, UK Institute of Cardiovascular Medicine and Science, and Royal Brompton Hospital, London, UK (P.G.S.); Department of Cardiovascular Medicine, Cleveland Clinic Foundation, Cleveland, OH (A.M.L.); Department of Vascular Medicine, Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands (J.J.P.K.); Cardiovascular Institute, Mount Sinai Medical Center, Icahn School of Medicine at Mount Sinai, New York (R.M.); CSL Behring, LLC, King of Prussia, PA (D.M.D., L.I.D.); Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.M.); Department of Cardiology, Warsaw Medical University, Warsaw, Poland (M.Z.); Department of Cardiology, Canisius Wilhelmina Ziekenhuis, Nijmegen, the Netherlands (T.O.O.); and Department of Medicine, Stanford University, Stanford, CA (R.A.H.).
authors.forename: Lawrence I
authors.initials: LI
authors.lastname: Deckelbaum
authors.affiliation: From PERFUSE Study Group, Cardiovascular Division, Department of Medicine, Beth Israel Deaconess Medical, Harvard Medical School, Boston, MA (C.M.G., S.K., Y.D., M.Y., P.J.); Duke Clinical Research Institute, Cardiovascular Division, Department of Medicine, Duke University Health, Durham, NC (P.T., J.H.A.); INSERM-Unité 1148, France Assistance Publique-Hôpitaux de Paris, Hôpital Bichat, France Université Paris-Diderot, Sorbonne- Paris Cité, France National Heart and Lung Institute, Paris, France (P.G.S.); Imperial College London, UK Institute of Cardiovascular Medicine and Science, and Royal Brompton Hospital, London, UK (P.G.S.); Department of Cardiovascular Medicine, Cleveland Clinic Foundation, Cleveland, OH (A.M.L.); Department of Vascular Medicine, Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands (J.J.P.K.); Cardiovascular Institute, Mount Sinai Medical Center, Icahn School of Medicine at Mount Sinai, New York (R.M.); CSL Behring, LLC, King of Prussia, PA (D.M.D., L.I.D.); Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.M.); Department of Cardiology, Warsaw Medical University, Warsaw, Poland (M.Z.); Department of Cardiology, Canisius Wilhelmina Ziekenhuis, Nijmegen, the Netherlands (T.O.O.); and Department of Medicine, Stanford University, Stanford, CA (R.A.H.).
authors.forename: Bela
authors.initials: B
authors.lastname: Merkely
authors.affiliation: From PERFUSE Study Group, Cardiovascular Division, Department of Medicine, Beth Israel Deaconess Medical, Harvard Medical School, Boston, MA (C.M.G., S.K., Y.D., M.Y., P.J.); Duke Clinical Research Institute, Cardiovascular Division, Department of Medicine, Duke University Health, Durham, NC (P.T., J.H.A.); INSERM-Unité 1148, France Assistance Publique-Hôpitaux de Paris, Hôpital Bichat, France Université Paris-Diderot, Sorbonne- Paris Cité, France National Heart and Lung Institute, Paris, France (P.G.S.); Imperial College London, UK Institute of Cardiovascular Medicine and Science, and Royal Brompton Hospital, London, UK (P.G.S.); Department of Cardiovascular Medicine, Cleveland Clinic Foundation, Cleveland, OH (A.M.L.); Department of Vascular Medicine, Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands (J.J.P.K.); Cardiovascular Institute, Mount Sinai Medical Center, Icahn School of Medicine at Mount Sinai, New York (R.M.); CSL Behring, LLC, King of Prussia, PA (D.M.D., L.I.D.); Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.M.); Department of Cardiology, Warsaw Medical University, Warsaw, Poland (M.Z.); Department of Cardiology, Canisius Wilhelmina Ziekenhuis, Nijmegen, the Netherlands (T.O.O.); and Department of Medicine, Stanford University, Stanford, CA (R.A.H.).
authors.forename: Maciej
authors.initials: M
authors.lastname: Zarebinski
authors.affiliation: From PERFUSE Study Group, Cardiovascular Division, Department of Medicine, Beth Israel Deaconess Medical, Harvard Medical School, Boston, MA (C.M.G., S.K., Y.D., M.Y., P.J.); Duke Clinical Research Institute, Cardiovascular Division, Department of Medicine, Duke University Health, Durham, NC (P.T., J.H.A.); INSERM-Unité 1148, France Assistance Publique-Hôpitaux de Paris, Hôpital Bichat, France Université Paris-Diderot, Sorbonne- Paris Cité, France National Heart and Lung Institute, Paris, France (P.G.S.); Imperial College London, UK Institute of Cardiovascular Medicine and Science, and Royal Brompton Hospital, London, UK (P.G.S.); Department of Cardiovascular Medicine, Cleveland Clinic Foundation, Cleveland, OH (A.M.L.); Department of Vascular Medicine, Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands (J.J.P.K.); Cardiovascular Institute, Mount Sinai Medical Center, Icahn School of Medicine at Mount Sinai, New York (R.M.); CSL Behring, LLC, King of Prussia, PA (D.M.D., L.I.D.); Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.M.); Department of Cardiology, Warsaw Medical University, Warsaw, Poland (M.Z.); Department of Cardiology, Canisius Wilhelmina Ziekenhuis, Nijmegen, the Netherlands (T.O.O.); and Department of Medicine, Stanford University, Stanford, CA (R.A.H.).
authors.forename: Ton Oude
authors.initials: TO
authors.lastname: Ophuis
authors.affiliation: From PERFUSE Study Group, Cardiovascular Division, Department of Medicine, Beth Israel Deaconess Medical, Harvard Medical School, Boston, MA (C.M.G., S.K., Y.D., M.Y., P.J.); Duke Clinical Research Institute, Cardiovascular Division, Department of Medicine, Duke University Health, Durham, NC (P.T., J.H.A.); INSERM-Unité 1148, France Assistance Publique-Hôpitaux de Paris, Hôpital Bichat, France Université Paris-Diderot, Sorbonne- Paris Cité, France National Heart and Lung Institute, Paris, France (P.G.S.); Imperial College London, UK Institute of Cardiovascular Medicine and Science, and Royal Brompton Hospital, London, UK (P.G.S.); Department of Cardiovascular Medicine, Cleveland Clinic Foundation, Cleveland, OH (A.M.L.); Department of Vascular Medicine, Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands (J.J.P.K.); Cardiovascular Institute, Mount Sinai Medical Center, Icahn School of Medicine at Mount Sinai, New York (R.M.); CSL Behring, LLC, King of Prussia, PA (D.M.D., L.I.D.); Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.M.); Department of Cardiology, Warsaw Medical University, Warsaw, Poland (M.Z.); Department of Cardiology, Canisius Wilhelmina Ziekenhuis, Nijmegen, the Netherlands (T.O.O.); and Department of Medicine, Stanford University, Stanford, CA (R.A.H.).
authors.forename: Robert A
authors.initials: RA
authors.lastname: Harrington
mesh_terms: D000208:Acute Disease; D000328:Adult; D000368:Aged; D000410:Alanine Transaminase / Q000097:blood; D001663:Bilirubin / Q000097:blood; D015415:Biomarkers / Q000097:blood; D003404:Creatinine / Q000097:blood; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D006207:Half-Life; D006470:Hemorrhage / Q000209:etiology; D006801:Humans; D008075:Lipoproteins, HDL / Q000009:adverse effects / Q000493:pharmacokinetics / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000188:drug therapy* / Q000473:pathology; D015990:Placebo Effect; D016016:Proportional Hazards Models; D016896:Treatment Outcome
chemical_list: D015415:Biomarkers; C584257:CSL112; D008075:Lipoproteins, HDL; D003404:Creatinine; D000410:Alanine Transaminase; D001663:Bilirubin
keywords: alipoprotein A-I; myocardial infarction