Rationale and design of Apo-I Event Reduction in Ischemic Syndromes I (AEGIS-I): A phase 2b, randomized, placebo-controlled, dose-ranging trial to investigate the safety and tolerability of CSL112, a reconstituted, infusible, human apoA-I, after acute myocardial infarction

American Heart Journal

Volumn 180, Issue , 2016, Pages 22-28

  Gibson, C Michael ^a   Korjian, Serge ^a   Tricoci, Pierluigi ^b   Daaboul, Yazan ^a   Alexander, John H ^b   Steg, Philippe G ^c   Lincoff, A Michael ^d   Kastelein, John J P ^e   Mehran, Roxana ^f   D'Andrea, Denise ^g   Merkely, Bela ^h   Zarebinski, Maciej ⁱ   Ophius, Ton Oude ^j   Harrington, Robert A ^k  

^a BETH ISRAEL DEACONESS MEDICAL CENTER   (United States)

^b DUKE CLINICAL RESEARCH INSTITUTE   (United States)

^c ROYAL BROMPTON HOSPITAL   (United Kingdom)

^d LERNER RESEARCH INSTITUTE   (United States)

^e UNIVERSITY OF AMSTERDAM   (Netherlands)

^f Department of Medicine   (United States)

^g CSL Behring LLC   (United States)

^h SEMMELWEIS UNIVERSITY   (Hungary)

ⁱ MEDICAL UNIVERSITY OF WARSAW   (Poland)

^j CANISIUS WILHELMINA HOSPITAL   (Netherlands)

^k STANFORD UNIVERSITY SCHOOL OF MEDICINE   (United States)

more..

Author keywords

[No Author keywords available]

Indexed keywords

ALANINE AMINOTRANSFERASE; APOLIPOPROTEIN A1; APOLIPOPROTEIN B; BILIRUBIN; BIOLOGICAL MARKER; C REACTIVE PROTEIN; CHOLESTEROL; CREATININE; CSL 112; FIBRINOGEN; HEMOGLOBIN A1C; HIGH DENSITY LIPOPROTEIN CHOLESTEROL; INTERLEUKIN 6; LOW DENSITY LIPOPROTEIN CHOLESTEROL; PLACEBO; TRIACYLGLYCEROL; TROPONIN I; UNCLASSIFIED DRUG; CSL112; HIGH DENSITY LIPOPROTEIN;

ACUTE HEART INFARCTION; AREA UNDER THE CURVE; ARTICLE; BLEEDING; BRAIN ISCHEMIA; CARDIOVASCULAR MORTALITY; CARDIOVASCULAR RISK; CHOLESTEROL TRANSPORT; CLINICAL EVALUATION; CONTROLLED STUDY; CORONARY ARTERY ATHEROSCLEROSIS; CREATININE BLOOD LEVEL; DOUBLE BLIND PROCEDURE; DRUG CLEARANCE; DRUG EFFICACY; DRUG MEGADOSE; DRUG SAFETY; DRUG TOLERABILITY; HEART PROTECTION; HOSPITALIZATION; HUMAN; KIDNEY FUNCTION; LIVER TOXICITY; LOW DRUG DOSE; MAJOR CLINICAL STUDY; MAXIMUM PLASMA CONCENTRATION; MILD RENAL IMPAIRMENT; MULTICENTER STUDY; NEPHROTOXICITY; OUTCOME ASSESSMENT; PHARMACODYNAMICS; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RENAL REPLACEMENT THERAPY; SINGLE DRUG DOSE; STATISTICAL ANALYSIS; TIME TO MAXIMUM PLASMA CONCENTRATION; UNSTABLE ANGINA PECTORIS; VOLUME OF DISTRIBUTION AT STEADY-STATE; ADULT; CLINICAL TRIAL; DOSE RESPONSE; DRUG EFFECTS; FEMALE; INTRAVENOUS DRUG ADMINISTRATION; KAPLAN MEIER METHOD; KIDNEY; LIVER; MALE; METHODOLOGY; MYOCARDIAL INFARCTION;

ADULT; DOSE-RESPONSE RELATIONSHIP, DRUG; DOUBLE-BLIND METHOD; FEMALE; HUMANS; INFUSIONS, INTRAVENOUS; KAPLAN-MEIER ESTIMATE; KIDNEY; LIPOPROTEINS, HDL; LIVER; MALE; MYOCARDIAL INFARCTION; RESEARCH DESIGN;

EID: 84994882510     PISSN: 00028703     EISSN: 10976744     Source Type: Journal    
DOI: 10.1016/j.ahj.2016.06.017     Document Type: Article

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