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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT03473223




Registration number
NCT03473223
Ethics application status
Date submitted
14/03/2018
Date registered
22/03/2018
Date last updated
9/05/2024

Titles & IDs
Public title
Study to Investigate CSL112 in Subjects With Acute Coronary Syndrome
Scientific title
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
Secondary ID [1] 0 0
CSL112_3001
Universal Trial Number (UTN)
Trial acronym
AEGIS-II
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Coronary Syndrome 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Apolipoprotein A-I [human] (apoA-I)
Other interventions - Placebo

Experimental: CSL112 - Apolipoprotein A-I [human]

Placebo Comparator: Placebo - 25% albumin solution diluted to 4.4%


Other interventions: Apolipoprotein A-I [human] (apoA-I)
Apolipoprotein A-I [human] (apoA-I) purified from human plasma for intravenous administration

Other interventions: Placebo
25% albumin solution diluted to 4.4%
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Time to first occurrence of any component of composite MACE (CV death, MI, or stroke )
Timepoint [1] 0 0
Through 90 days
Secondary outcome [1] 0 0
Key secondary outcome: Total number of hospitalizations for coronary, cerebral, or peripheral ischemia
Timepoint [1] 0 0
Through 90 days
Secondary outcome [2] 0 0
Key secondary outcome: Time to first occurrence of CV death, MI, or stroke
Timepoint [2] 0 0
Through 180 days
Secondary outcome [3] 0 0
Key secondary outcome: Time to first occurrence of CV death, MI, or stroke
Timepoint [3] 0 0
Through 365 days
Secondary outcome [4] 0 0
Time to occurrence of CV death
Timepoint [4] 0 0
Through 90 days
Secondary outcome [5] 0 0
Time to first occurrence of MI
Timepoint [5] 0 0
Through 90 days
Secondary outcome [6] 0 0
Time to first occurrence of stroke
Timepoint [6] 0 0
Through 90 days
Secondary outcome [7] 0 0
Time to occurrence of all-cause death
Timepoint [7] 0 0
Through 365 days
Secondary outcome [8] 0 0
Number of subjects with adverse events
Timepoint [8] 0 0
Through 90 days
Secondary outcome [9] 0 0
Percent of subjects with adverse events
Timepoint [9] 0 0
Through 90 days
Secondary outcome [10] 0 0
Number of subjects with treatment-related adverse events
Timepoint [10] 0 0
Through 365 days
Secondary outcome [11] 0 0
Percent of subjects with treatment-related adverse events
Timepoint [11] 0 0
Through 365 days
Secondary outcome [12] 0 0
Number of subjects with serious adverse events
Timepoint [12] 0 0
Through 365 days
Secondary outcome [13] 0 0
Percent of subjects with serious adverse events
Timepoint [13] 0 0
Through 365 days
Secondary outcome [14] 0 0
Number of subjects with a shift in clinical laboratory assessments from baseline to worst post-treatment value according to normal range criteria (normal, high, or low)
Timepoint [14] 0 0
Baseline and 29 days
Secondary outcome [15] 0 0
Percent of subjects with a shift in clinical laboratory assessments from baseline to worst post-treatment value according to normal range criteria (normal, high, or low)
Timepoint [15] 0 0
Baseline and 29 days

Eligibility
Key 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):

1. Diabetes mellitus on pharmacotherapy OR

2. 2 or more of the following: age = 65 years, prior history of MI, peripheral
arterial disease
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Ongoing hemodynamic instability

- Evidence of hepatobiliary disease

- Evidence of severe chronic kidney disease

- Plan to undergo scheduled coronary artery bypass graft surgery as treatment for the
index MI

- Known history of allergies, hypersensitivity, or deficiencies to soy bean, peanut or
albumin

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
21/03/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
17/11/2023
Sample size
Target
Accrual to date
Final
18200
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,TazmaniaVIC,WA
Recruitment hospital [1] 0 0
0360087 - Campbelltown Hospital - Campbelltown
Recruitment hospital [2] 0 0
0360069 - Liverpool Hospital - Liverpool
Recruitment hospital [3] 0 0
0360070 - Royal North Shore Hospital - St. Leonards
Recruitment hospital [4] 0 0
0360071 - Wollongong Hospital - Wollongong
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0360063 - Cairns Base Hospital - Cairns
Recruitment hospital [6] 0 0
0360062 - The Prince Charles Hospital - Chermside
Recruitment hospital [7] 0 0
0360061 - Royal Brisbane Hospital - Herston
Recruitment hospital [8] 0 0
0360060 - Gold Coast Hospital - Southport
Recruitment hospital [9] 0 0
0360057 - Royal Adelaide Hospital - Adelaide
Recruitment hospital [10] 0 0
0360032 - Flinders Medical Centre - Bedford Park
Recruitment hospital [11] 0 0
0360055 - Queen Elizabeth Hospital - Woodville South
Recruitment hospital [12] 0 0
0360084 - Royal Hobart Hospital - Hobart
Recruitment hospital [13] 0 0
0360092 - Monash Medical Centre - Clayton
Recruitment hospital [14] 0 0
0360036 - The Northern Hospital - Epping
Recruitment hospital [15] 0 0
0360096 - Peninsula Health - Frankston
Recruitment hospital [16] 0 0
0360076 - Geelong Hospital - Geelong
Recruitment hospital [17] 0 0
0360081 - Peninsula Heart Centre - Langwarrin
Recruitment hospital [18] 0 0
0360073 - The Alfred Hospital - Melbourne
Recruitment hospital [19] 0 0
0360080 - Fiona Stanley Hospital - Murdoch
Recruitment hospital [20] 0 0
0360059 - Royal Perth Hospital - Perth
Recruitment hospital [21] 0 0
0360072 - John Hunter Hospital - New Lambton Heights
Recruitment postcode(s) [1] 0 0
2560 - Campbelltown
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2170 - Liverpool
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2065 - St. Leonards
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2500 - Wollongong
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4870 - Cairns
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4032 - Chermside
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4029 - Herston
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4215 - Southport
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5000 - Adelaide
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5042 - Bedford Park
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5011 - Woodville South
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7001 - Hobart
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3168 - Clayton
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3076 - Epping
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3199 - Frankston
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3320 - Geelong
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3910 - Langwarrin
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3004 - Melbourne
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6150 - Murdoch
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6000 - Perth
Recruitment postcode(s) [21] 0 0
2305 - New Lambton Heights
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Germany
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Germany
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Germany
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Germany
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Germany
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Germany
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Germany
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Germany
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Germany
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Germany
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Germany
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Germany
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Germany
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Germany
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Germany
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Germany
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Germany
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Piraeus
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Hong Kong
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Kwai Chung
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Hong Kong
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Sha Tin
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Hungary
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Budapest
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Hungary
State/province [226] 0 0
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Country [227] 0 0
Hungary
State/province [227] 0 0
Dombóvár
Country [228] 0 0
Hungary
State/province [228] 0 0
Gyula
Country [229] 0 0
Hungary
State/province [229] 0 0
Gyor
Country [230] 0 0
Hungary
State/province [230] 0 0
Kaposvár
Country [231] 0 0
Hungary
State/province [231] 0 0
Kecskemét
Country [232] 0 0
Hungary
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Nyíregyháza
Country [233] 0 0
Hungary
State/province [233] 0 0
Szeged
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Hungary
State/province [234] 0 0
Szekszárd
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Hungary
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Szolnok
Country [236] 0 0
Hungary
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Székesfehérvár
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Hungary
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Zalaegerszeg
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Israel
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Israel
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Ashkelon
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Israel
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Be'er Ya'aqov
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Israel
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Israel
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Israel
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Israel
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Israel
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Kfar Saba
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Israel
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Israel
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Israel
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Israel
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Ramat Gan
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Israel
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Rehovot
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Israel
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Safed
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Israel
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Tel Aviv-Yafo
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Italy
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Bergamo
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Italy
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Brescia
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Italy
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Busto Arsizio
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Italy
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Caserta
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Italy
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Catanzaro
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Italy
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Italy
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Milano
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Italy
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Napoli
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Italy
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Osio Sotto
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Italy
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Palermo
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Italy
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Pavia
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Italy
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Roma
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Italy
State/province [265] 0 0
Rozzano
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Japan
State/province [266] 0 0
Okayama
Country [267] 0 0
Japan
State/province [267] 0 0
Adachi-Ku
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Japan
State/province [268] 0 0
Amagasaki-Shi
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Japan
State/province [269] 0 0
Aoba-Ku
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Japan
State/province [270] 0 0
Asahi-Shi
Country [271] 0 0
Japan
State/province [271] 0 0
Fuchu-Shi
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Japan
State/province [272] 0 0
Fukuoka-Shi
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Japan
State/province [273] 0 0
Itabashi-Ku
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Japan
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Izunokuni-Shi
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Japan
State/province [275] 0 0
Kanazawa-Shi
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Japan
State/province [276] 0 0
Kasuga-Shi
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Japan
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Kisarazu-Shi
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Japan
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Kochi-Shi
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Japan
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Kumamoto-Shi
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Japan
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Japan
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Japan
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Japan
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Japan
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Japan
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Japan
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Japan
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Japan
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Japan
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Japan
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Japan
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Japan
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Japan
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Korea, Republic of
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Mexico
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Mexico
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Mexico
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Netherlands
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Poland
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Poland
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Grodzisk Mazowiecki
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Poland
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Poland
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Poland
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Poland
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Poland
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Poland
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Poland
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Portugal
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Portugal
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Romania
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Romania
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Romania
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Romania
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Romania
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Romania
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Romania
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Romania
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Romania
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Romania
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Romania
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Romania
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Târgu-Mures
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Russian Federation
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Arkhangel'sk
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Russian Federation
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Barnaul
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Russian Federation
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Ekaterinburg
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Russian Federation
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Ivanovo
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Russian Federation
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Kaluga
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Russian Federation
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Kemerovo
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Russian Federation
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Krasnoyarsk
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Russian Federation
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Kursk
Country [428] 0 0
Russian Federation
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Lyubertsy
Country [429] 0 0
Russian Federation
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Moscow
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Russian Federation
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Moskva
Country [431] 0 0
Russian Federation
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Nizhniy Novgorod
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Russian Federation
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Russian Federation
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Penza
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Russian Federation
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Perm
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Russian Federation
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Rostov-on-Don
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Russian Federation
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Saint Petersburg
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Russian Federation
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Samara
Country [438] 0 0
Russian Federation
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Sankt-Peterburg
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Russian Federation
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Russian Federation
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Tomsk
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Russian Federation
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Tula
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Russian Federation
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Tyumen
Country [443] 0 0
Russian Federation
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Yaroslavl'
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Russian Federation
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Savski Venac
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Serbia
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Serbia
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Serbia
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Serbia
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Niš
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Serbia
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Serbia
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Sremska Kamenica
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Serbia
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Serbia
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Serbia
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Serbia
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Slovakia
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Nitra
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Slovakia
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Cape Town
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Centurion
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Sunninghill
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South Africa
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Country [467] 0 0
Spain
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Country [468] 0 0
Spain
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Country [469] 0 0
Spain
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Country [470] 0 0
Spain
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Barcelona
Country [471] 0 0
Spain
State/province [471] 0 0
Huelva
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Spain
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L'hospitalet de Llobregat
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Spain
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Lleida
Country [474] 0 0
Spain
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Country [475] 0 0
Spain
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Country [476] 0 0
Spain
State/province [476] 0 0
Santander
Country [477] 0 0
Spain
State/province [477] 0 0
Tarragona
Country [478] 0 0
Spain
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Country [479] 0 0
Spain
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
CSL Behring
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT03473223
Trial related presentations / publications
Gibson CM, Duffy D, Korjian S, Bahit MC, Chi G, Alexander JH, Lincoff AM, Heise M, Tricoci P, Deckelbaum LI, Mears SJ, Nicolau JC, Lopes RD, Merkely B, Lewis BS, Cornel JH, Trebacz J, Parkhomenko A, Libby P, Sacks FM, Povsic TJ, Bonaca M, Goodman SG, Bhatt DL, Tendera M, Steg PG, Ridker PM, Aylward P, Kastelein JJP, Bode C, Mahaffey KW, Nicholls SJ, Pocock SJ, Mehran R, Harrington RA; AEGIS-II Committees and Investigators. Apolipoprotein A1 Infusions and Cardiovascular Outcomes after Acute Myocardial Infarction. N Engl J Med. 2024 May 2;390(17):1560-1571. doi: 10.1056/NEJMoa2400969. Epub 2024 Apr 6.
Public notes

Contacts
Principal investigator
Name 0 0
Danielle Duffy, MD
Address 0 0
CSL Behring - Sr Global Clinical Program Dir - CV & Metabolism
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT03473223