A Phase 3, Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Investigate the Efficacy and Safety of CSL112 in Subjects With Acute Coronary Syndrome
A Phase 3, Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Investigate the Efficacy and Safety of CSL112 in Subjects With Acute Coronary Syndrome
This is a phase 3, multicenter, double-blind, randomized, placebo-controlled, parallel-group study to evaluate the efficacy and safety of CSL112 on reducing the risk of major adverse CV events [MACE - cardiovascular (CV) death, myocardial infarction (MI), and stroke] in subjects with acute coronary syndrome (ACS) diagnosed with either ST-segment elevation myocardial infarction (STEMI) or non-ST-segment elevation myocardial infarction (NSTEMI), including those managed with percutaneous coronary intervention (PCI) or medically managed.
Inclusion Criteria:
Male or female least 18 years of age
Evidence of myocardial necrosis, consistent with type I (spontaneous) MI
No suspicion of acute kidney injury
Evidence of multivessel coronary artery disease
Presence of established cardiovascular risk factor(s):
Exclusion Criteria:
San Diego, California 92103, United States
Colorado Springs, Colorado 80909, United States
Greeley, Colorado 80631, United States
Washington D.C., District of Columbia 20010, United States
Washington D.C., District of Columbia 20037, United States
Clearwater, Florida 33756, United States
Safety Harbor, Florida 34695, United States
Kalamazoo, Michigan 49048, United States
Neptune City, New Jersey 07753, United States
Liverpool, New York 13088, United States
Rochester, New York 14642, United States
The Bronx, New York 10461, United States
Chapel Hill, North Carolina 27517, United States
Lumberton, North Carolina 28358, United States
Winston-Salem, North Carolina 27157, United States
Knoxville, Tennessee 37934, United States
Manitowoc, Wisconsin 54220, United States
Ciudad Autonoma Buenos Aires, 1413, Argentina
Ciudad Autónoma Buenos Aires, 1118, Argentina
Ciudad Autónoma Buenos Aires, 1280, Argentina
Ciudad Autónoma Buenos Aires, 1428, Argentina
Ciudad Autónoma Buenos Aires, 1430, Argentina
Ciudad Autónoma Buenos Aires, 4071, Argentina
Innsbruck, 6020, Austria
São Bernardo do Campo, 09780-000, Brazil
São José do Rio Preto, 15090-000, Brazil
Sofia, 1309, Bulgaria
Trois-Rivières, Quebec G8Z 3R9, Canada
Krapinske Toplice, 49217, Croatia
Bad Friedrichshall, 74177, Germany
Essen, 45138, Germany
Rüsselsheim am Main, 65428, Germany
Ioannina, 451 10, Greece
Szeged, 6725, Hungary
Kurashiki-shi, Okayama-ken 710-8602, Japan
Adachi-Ku, 120-0006, Japan
Amagasaki-Shi, 660-0828, Japan
Aoba-Ku, 227-8501, Japan
Asahi-Shi, 289-2511, Japan
Fuchu-Shi, 183-0003, Japan
Itabashi-Ku, 173-0003, Japan
Itabashi-Ku, 173-8610, Japan
Izunokuni-Shi, 410-2211, Japan
Kasuga-Shi, Kasuga-Shi, Japan
Kisarazu-Shi, 292-0822, Japan
Kurume-Shi, 830-0011, Japan
Kurume-Shi, 830-8577, Japan
Kusatsu-Shi, 525-0066, Japan
Matsusaka-Shi, 515-8566, Japan
Meguro-ku, 1538515, Japan
Seto-Shi, 489-8642, Japan
Shinjuku-Ku, 162-8666, Japan
Suita-Shi, 565-8565, Japan
Tomakomai-Shi, 053-8506, Japan
Urayasu-Shi, 279-0001, Japan
Kaunas, LT-50161, Lithuania
Guadalajara, Jalisco 44340, Mexico
San Luis Potosí City, 78200, Mexico
Lørenskog, 1474, Norway
Dąbrowa Górnicza, 41-300, Poland
Kędzierzyn-Koźle, 47-200, Poland
Senhora da Hora, 4460-298, Portugal
Vila Real, 5000-508, Portugal
Bucharest, 010825, Romania
Târgu Mureş, 540136, Romania
Novosibirsk, 630008, Russia
Saint Petersburg, 192242, Russia
Afyonkarahisar, 03200, Turkey (Türkiye)
Bağcılar, 34100, Turkey (Türkiye)
Kocaeli, 4138, Turkey (Türkiye)
Maltepe, 34846, Turkey (Türkiye)
Yıldırım, 16310, Turkey (Türkiye)
Ivano-Frankivsk, 76018, Ukraine
Chelmsford, CM1 7ET, United Kingdom
Clydebank, G81 4DY, United Kingdom
Harrow, HA1 3UJ, United Kingdom
Lincoln, LN2 5QY, United Kingdom
Manchester, M13 9WL, United Kingdom
Newcastle upon Tyne, NE7 7DN, United Kingdom
Torquay, TQ2 7AA, United Kingdom