Acute Myocardial Infarction

A Phase 2b Study of CSL112 in Subjects With Acute Myocardial Infarction.

NCT02108262 | PHASE 2 | INTERVENTIONAL

This is a multicenter randomized, double-blind, placebo-controlled, parallel-group, dose-ranging phase 2b study to investigate the hepatic and renal safety and tolerability of multiple dose administration of two dose levels of CSL112 compared with placebo in subjects with acute myocardial infarction (AMI).

189 Sites

1267 Participants

Recruiting

18 Years to 17 Years

If interested, contact clinicaltrials@cslbehring.com for more information

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Find closest sites:

SUBMIT

Study Site

Birmingham,Alabama,United States,35211

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Huntsville,Alabama,United States,35801

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Concord,California,United States,94520

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Concord,California,United States,94520

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Sacramento,California,United States,95819

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Torrance,California,United States,90502

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Littleton,Colorado,United States,80120

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Bridgeport,Connecticut,United States,06606

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Danbury,Connecticut,United States,06810

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Clearwater,Florida,United States,33756

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Jacksonville,Florida,United States,32209

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Atlanta,Georgia,United States,30322

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Boise,Idaho,United States,83712

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Evanston,Illinois,United States,60201

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Elkhart,Indiana,United States,46514

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Indianapolis,Indiana,United States,46290

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West Des Moines,Iowa,United States,50266

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Lexington,Kentucky,United States,40504

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Lexington,Kentucky,United States,40536

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Louisville,Kentucky,United States,40202

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Alexandria,Louisiana,United States,71301

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Auburn,Maine,United States,04210

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Bangor,Maine,United States,04401

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Baltimore,Maryland,United States,21215

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Detroit,Michigan,United States,48202

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Petoskey,Michigan,United States,49770

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Minneapolis,Minnesota,United States,55407

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Saint Paul,Minnesota,United States,55102

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Tupelo,Mississippi,United States,38801

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Brooklyn,New York,United States,11215

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Buffalo,New York,United States,14215

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New York,New York,United States,10029

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Durham,North Carolina,United States,27705

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Elizabeth City,North Carolina,United States,27909

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High Point,North Carolina,United States,27262

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Winston-Salem,North Carolina,United States,27157

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Cincinnati,Ohio,United States,45219

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Hershey,Pennsylvania,United States,17033

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Lancaster,Pennsylvania,United States,17604

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Philadelphia,Pennsylvania,United States,19104

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Greenwood,South Carolina,United States,29646

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Rapid City,South Dakota,United States,57701

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Greeneville,Tennessee,United States,37745

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Amarillo,Texas,United States,79106

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Dallas,Texas,United States,75216

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Wichita Falls,Texas,United States,76301

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Richmond,Virginia,United States,23298

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Wausau,Wisconsin,United States,54401

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Herston,Queensland,Australia,4029

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Adelaide,South Australia,Australia,5000

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Woodville South,South Australia,Australia,5011

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Epping,Victoria,Australia,3076

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Geelong,Victoria,Australia,3220

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Innsbruck,Austria,6020

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Vienna,Austria,1090

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Wien,Austria,1160

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Blagoevgrad,Bulgaria,2700

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Burgas,Bulgaria,8000

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Dobrich,Bulgaria,9300

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Haskovo,Bulgaria,6300

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Pazardzhik,Bulgaria,4400

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Pazardzhik,Bulgaria,4400

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Pleven,Bulgaria,5800

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Plovdiv,Bulgaria,4002

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Plovdiv,Bulgaria,4002

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Sandanski,Bulgaria,2800

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Sofia,Bulgaria,1233

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Sofia,Bulgaria,1309

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Sofia,Bulgaria,1407

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Sofia,Bulgaria,1407

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Sofia,Bulgaria,152

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Sofia,Bulgaria,1750

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Varna,Bulgaria,9010

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Veliko Tarnovo,Bulgaria,5000

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Yambol,Bulgaria,8600

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Edmonton,Alberta,Canada,T5H3V9

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Edmonton,Alberta,Canada,T6G2B7

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Penticton,British Columbia,Canada,V2A3G6

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Victoria,British Columbia,Canada,V8R4R2

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St. Johns,Newfoundland and Labrador,Canada,A1B3V6

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London,Ontario,Canada,N6A5A5

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Newmarket,Ontario,Canada,L3Y2P7

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Montreal,Quebec,Canada,H2W1T8

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Quebec,Canada,G1V4G5

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Brno,Czechia,62500

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Brno,Czechia,65691

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Hradec Kralove,Czechia,50005

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Jablonec nad Nisou,Czechia,46660

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Jihlava,Czechia,58633

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Kolin,Czechia,28000

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Nachod,Czechia,54701

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Ostrava,Czechia,70852

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Pardubice,Czechia,53203

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Praha 10,Czechia,10034

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Praha 2,Czechia,12808

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Praha 2,Czechia,12808

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Praha 4 - Krc,Czechia,14059

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Praha 5,Czechia,15006

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Teplice,Czechia,41501

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Usti nad Orlici,Czechia,56218

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Alborg,Denmark,9100

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Esbjerg,Denmark,6700

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Hellerup,Denmark,2900

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Hvidovre,Denmark,2650

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Odense,Denmark,5000

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Pessac,Gironde,France,33604

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Toulouse cedex 3,Haute Garonne,France,31076

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Nantes cedex,Loire Antlantique,France,44093

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Paris cedex 12,Paris,France,75571

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Pau,Pyrenees Atlantiques,France,64046

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Paris,France,75013

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Freiburg,Baden Wuerttemberg,Germany,79106

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Berlin,Berin,Germany,10249

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Franfurt,Hessen,Germany,65929

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Hannover,Niedersachsen,Germany,30625

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Luedenscheid,Nordrhein Westfalen,Germany,58509

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Ludwigshafen,Rheinland Pfalz,Germany,67063

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Mainz,Rheinland Pfalz,Germany,55131

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Berlin,Germany,10117

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Berlin,Germany,10967

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Berlin,Germany,12351

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Hamburg,Germany,20246

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Budapest,Hungary,1023

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Budapest,Hungary,1122

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Budapest,Hungary,1134

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Gyor,Hungary,9024

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Nyiregyhaza,Hungary,4400

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Pecs,Hungary,7624

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Szeged,Hungary,6720

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Szolnok,Hungary,5000

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Ashkelon,Israel,7830604

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Beer Sheva,Israel,8410101

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Haifa,Israel,3109601

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Holon,Israel,5822012

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Jerusalem,Israel,91120

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Jerusalem,Israel,9124001

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Nahariya,Israel,2210001

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Ramat Gan,Israel,5262000

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Safed,Israel,13100

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Legnano,Milano,Italy,20025

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Magenta,Milano,Italy,20013

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Rozzano,Milano,Italy,20089

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Benevento,Italy,82100

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Napoli,Italy,80131

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Rimini,Italy,47923

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Roma,Italy,00189

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Terni,Italy,05100

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Udine,Italy,33100

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Alkmaar,Netherlands,1815JD

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Amsterdam,Netherlands,091AC

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Amsterdam,Netherlands,1081HV

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Amsterdam,Netherlands,1105AZ

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Ede,Netherlands,6716RP

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Leeuwarden,Netherlands,8934AD

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Nieuwegein,Netherlands,3435CM

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Nijmegen,Netherlands,6525EC

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Rotterdam,Netherlands,3079DZ

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Sneek,Netherlands,8601ZK

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Tilburg,Netherlands,5042AD

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Venlo,Netherlands,5912BL

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Gdansk,Poland,80-952

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Grodzisk Mazowiecki,Poland,05-825

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Inowroclaw,Poland,88-10

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Kielce,Poland,25-736

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Krakow,Poland,31-202

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Lodz,Poland,91-347

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Starogard Gdanski,Poland,83-200

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Walbrzych,Poland,58-309

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Warszawa,Poland,01-211

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Wejherowo,Poland,84-200

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Wroclaw,Poland,50-981

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L'Hospitalet de Llobregat,Barcelona,Spain,08907

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A Coruna,La Coruna,Spain,15006

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Santiago de Compostela,La Coruna,Spain,15706

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Barcelona,Spain,08003

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Barcelona,Spain,08023

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Barcelona,Spain,08036

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Madrid,Spain,28007

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Madrid,Spain,28034

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Madrid,Spain,28040

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Malaga,Spain,29010

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Tarragona,Spain,43007

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Valencia,Spain,46010

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Clydebank,Dunbartonshire,United Kingdom,G811DY

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Basildon,Essex,United Kingdom,SS165NL

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Romford,Essex,United Kingdom,UM70AG

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London,Greater London,United Kingdom,E29JX

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Leicester,Leicestershire,United Kingdom,LE39QP

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Newcastle upon Tyne,Tyne & Wear,United Kingdom,NE77DN

Study Eligibility Criteria

Inclusion Criteria

* Men or women, at least 18 years of age, with evidence of myocardial necrosis in a clinical setting consistent with a type I (spontaneous) acute myocardial infarction (AMI), in the last week.

Exclusion Criteria

* Ongoing hemodynamic instability
* Evidence of hepatobiliary disease
* Evidence of chronic kidney disease (CKD) (Stage III, IV, or V), defined as moderate or severe renal impairment or if subject is receiving dialysis
* Evidence of unstable renal function
* History of acute kidney injury after previous exposure to an intravenous contrast agent.
* Known history of allergies, hypersensitivity or deficiencies to CSL112 or any of its components
* Other severe comorbid condition, concurrent medication, or other issue that renders the subject unsuitable for participation in the study

Additional Studies

Additional studies can be found at ClinicalTrials.gov