Trial Review

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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/NCT01663402




Registration number
NCT01663402
Ethics application status
Date submitted
8/08/2012
Date registered
13/08/2012
Date last updated
18/03/2019

Titles & IDs
Public title
ODYSSEY Outcomes: Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With Alirocumab
Scientific title
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Effect of Alirocumab (SAR236553/REGN727) on the Occurrence of Cardiovascular Events in Patients Who Have Recently Experienced an Acute Coronary Syndrome
Secondary ID [1] 0 0
2011-005698-21
Secondary ID [2] 0 0
EFC11570
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atherosclerotic Cardiovascular Disease 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Alirocumab
Treatment: Drugs - Placebo
Treatment: Drugs - LMT

Placebo Comparator: Placebo - Placebo (for alirocumab) subcutaneous (SC) injection every 2 weeks (Q2W) added to stable Lipid-Modifying Therapy (LMT) for up to 64 months.

Experimental: Alirocumab 75 mg Q2W/Up to 150 mg Q2W - Alirocumab 75 mg SC injection Q2W added to stable LMT for up to 64 months. Alirocumab dose up-titrated to 150 mg Q2W from Month 2 when Low-Density Lipoprotein Cholesterol (LDL-C) levels >=50 mg/dL (1.29 mmol/L) at Month 1; or if up-titration was missed due to unavailability of LDL-C value, it was up-titrated at month 4 based on LDL-C value at Month 2. For participants receiving 150 mg Q2W, alirocumab dose was down-titrated in a blinded manner to 75 mg Q2W if two consecutive values of LDL-C were <25 mg/dL (0.65 mmol/L). For participants receiving 75 mg Q2W, alirocumab dose was switched to placebo in a blinded manner if two consecutive values of LDL-C were <15 mg/dL (0.39 mmol/L).


Treatment: Drugs: Alirocumab
Alirocumab administered as SC injection of 1 mL in the abdomen or thigh with a disposable auto-injector.

Treatment: Drugs: Placebo
Placebo matched to alirocumab administered as a SC injection of 1 mL in the abdomen or thigh with a disposable auto-injector.

Treatment: Drugs: LMT
Statins (atorvastatin or rosuvastatin) at stable maximal tolerated dose of statin with or without other LMT as clinically indicated.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Time to First Occurrence of Major Adverse Cardiovascular Event (MACE); Percentage of Observed Participants With Outcome Measure Events During the Study
Timepoint [1] 0 0
From randomization up to 64 months
Secondary outcome [1] 0 0
Time to First Occurrence of Any Coronary Heart Disease Event; Percentage of Observed Participants With Outcome Measure Events During the Study
Timepoint [1] 0 0
From randomization up to 64 months
Secondary outcome [2] 0 0
Time to First Occurrence of Any Major Coronary Heart Disease Event; Percentage of Observed Participants With Outcome Measure Events During the Study
Timepoint [2] 0 0
From randomization up to 64 months
Secondary outcome [3] 0 0
Time to First Occurrence of Any Cardiovascular Event; Percentage of Observed Participants With Outcome Measure Events During the Study
Timepoint [3] 0 0
From randomization up to 64 months
Secondary outcome [4] 0 0
Time to First Occurrence of All-Cause Mortality, Non-Fatal Myocardial Infarction, Non-Fatal Ischemic Stroke; Percentage of Observed Participants With Outcome Measure Events During the Study
Timepoint [4] 0 0
From randomization up to 64 months
Secondary outcome [5] 0 0
Time to Coronary Heart Disease Death; Percentage of Observed Participants With Outcome Measure Events During the Study
Timepoint [5] 0 0
From randomization up to 64 months
Secondary outcome [6] 0 0
Time to Cardiovascular Death; Percentage of Observed Participants With Outcome Measure Events During the Study
Timepoint [6] 0 0
From randomization up to 64 months
Secondary outcome [7] 0 0
Time to All-Cause Death; Percentage of Observed Participants With Outcome Measure Events During the Study
Timepoint [7] 0 0
From randomization up to 64 months
Secondary outcome [8] 0 0
Time to First Occurrence of Any Non-Fatal Myocardial Infarction; Percentage of Observed Participants With Outcome Measure Events During the Study
Timepoint [8] 0 0
From randomization up to 64 months
Secondary outcome [9] 0 0
Time to First Occurrence of Fatal or Any Non-Fatal Ischemic Stroke; Percentage of Observed Participants With Outcome Measure Events During the Study
Timepoint [9] 0 0
From randomization up to 64 months
Secondary outcome [10] 0 0
Time to First Occurrence of Any Unstable Angina Requiring Hospitalization; Percentage of Observed Participants With Outcome Measure Events During the Study
Timepoint [10] 0 0
From randomization up to 64 months
Secondary outcome [11] 0 0
Time to First Occurrence of Any Ischemia-Driven Coronary Revascularization Procedure; Percentage of Observed Participants With Outcome Measure Events During the Study
Timepoint [11] 0 0
From randomization up to 64 months
Secondary outcome [12] 0 0
Time to First Occurrence of Any Congestive Heart Failure (CHF) Requiring Hospitalization; Percentage of Observed Participants With Outcome Measure Events During the Study
Timepoint [12] 0 0
From randomization up to 64 months

Eligibility
Key inclusion criteria
Inclusion criteria :

Recently (< 52 weeks) hospitalized for ACS.
Minimum age
40 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:

- Age < 40 years.

- ACS event occurring more than 52 weeks prior to randomization visit.

- LDL-C likely to be <70 mg/dL (<1.81 mmo/L), and apolipoprotein B (ApoB) <80 mg/dL
(<0.8 g/L), and non - high-density lipoprotein cholesterol (HDL-C) <100 mg/dL (<2.59
mmol/L) with evidence-based medical and dietary management of dyslipidemia.

The above information is not intended to contain all considerations relevant to a
participant's potential participation in a clinical trial.

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 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
1/10/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
23/01/2018
Sample size
Target
Accrual to date
Final
18924
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Investigational Site Number 036002 - Ashford
Recruitment hospital [2] 0 0
Investigational Site Number 036023 - Auchenflower
Recruitment hospital [3] 0 0
Investigational Site Number 036024 - Ballarat
Recruitment hospital [4] 0 0
Investigational Site Number 036020 - Bedford Park
Recruitment hospital [5] 0 0
Investigational Site Number 036015 - Bruce
Recruitment hospital [6] 0 0
Investigational Site Number 036026 - Cairns
Recruitment hospital [7] 0 0
Investigational Site Number 036005 - Chermside
Recruitment hospital [8] 0 0
Investigational Site Number 036008 - Chermside
Recruitment hospital [9] 0 0
Investigational Site Number 036011 - Coffs Harbour
Recruitment hospital [10] 0 0
Investigational Site Number 036003 - Concord
Recruitment hospital [11] 0 0
Investigational Site Number 036017 - Elizabeth Vale
Recruitment hospital [12] 0 0
Investigational Site Number 036006 - Fullarton
Recruitment hospital [13] 0 0
Investigational Site Number 036004 - Gosford
Recruitment hospital [14] 0 0
Investigational Site Number 036019 - Heidelberg West
Recruitment hospital [15] 0 0
Investigational Site Number 036027 - Hobart
Recruitment hospital [16] 0 0
Investigational Site Number 036009 - Kogarah
Recruitment hospital [17] 0 0
Investigational Site Number 036012 - Mildura
Recruitment hospital [18] 0 0
Investigational Site Number 036028 - Nambour
Recruitment hospital [19] 0 0
Investigational Site Number 036013 - New Lambton
Recruitment hospital [20] 0 0
Investigational Site Number 036010 - Perth
Recruitment hospital [21] 0 0
Investigational Site Number 036014 - Prahran
Recruitment hospital [22] 0 0
Investigational Site Number 036018 - Redcliffe
Recruitment hospital [23] 0 0
Investigational Site Number 036022 - Richmond
Recruitment hospital [24] 0 0
Investigational Site Number 036025 - Woodville South
Recruitment hospital [25] 0 0
Investigational Site Number 036021 - Woolloongabba
Recruitment postcode(s) [1] 0 0
5035 - Ashford
Recruitment postcode(s) [2] 0 0
4066 - Auchenflower
Recruitment postcode(s) [3] 0 0
3353 - Ballarat
Recruitment postcode(s) [4] 0 0
5042 - Bedford Park
Recruitment postcode(s) [5] 0 0
2617 - Bruce
Recruitment postcode(s) [6] 0 0
4870 - Cairns
Recruitment postcode(s) [7] 0 0
4032 - Chermside
Recruitment postcode(s) [8] 0 0
2450 - Coffs Harbour
Recruitment postcode(s) [9] 0 0
2137 - Concord
Recruitment postcode(s) [10] 0 0
5112 - Elizabeth Vale
Recruitment postcode(s) [11] 0 0
5063 - Fullarton
Recruitment postcode(s) [12] 0 0
2250 - Gosford
Recruitment postcode(s) [13] 0 0
3081 - Heidelberg West
Recruitment postcode(s) [14] 0 0
7001 - Hobart
Recruitment postcode(s) [15] 0 0
2217 - Kogarah
Recruitment postcode(s) [16] 0 0
3500 - Mildura
Recruitment postcode(s) [17] 0 0
4560 - Nambour
Recruitment postcode(s) [18] 0 0
2305 - New Lambton
Recruitment postcode(s) [19] 0 0
6000 - Perth
Recruitment postcode(s) [20] 0 0
3004 - Prahran
Recruitment postcode(s) [21] 0 0
4020 - Redcliffe
Recruitment postcode(s) [22] 0 0
3121 - Richmond
Recruitment postcode(s) [23] 0 0
5011 - Woodville South
Recruitment postcode(s) [24] 0 0
4102 - Woolloongabba
Recruitment outside Australia
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Talca
Country [176] 0 0
Chile
State/province [176] 0 0
Temuco
Country [177] 0 0
Chile
State/province [177] 0 0
Valdivia
Country [178] 0 0
Chile
State/province [178] 0 0
Viña Del Mar
Country [179] 0 0
China
State/province [179] 0 0
Baotou
Country [180] 0 0
China
State/province [180] 0 0
Beijing
Country [181] 0 0
China
State/province [181] 0 0
Changchun
Country [182] 0 0
China
State/province [182] 0 0
Changsha
Country [183] 0 0
China
State/province [183] 0 0
Chongqing
Country [184] 0 0
China
State/province [184] 0 0
Fuzhou
Country [185] 0 0
China
State/province [185] 0 0
Guangzhou
Country [186] 0 0
China
State/province [186] 0 0
Guiyang
Country [187] 0 0
China
State/province [187] 0 0
Hangzhou
Country [188] 0 0
China
State/province [188] 0 0
Hohhot
Country [189] 0 0
China
State/province [189] 0 0
Jinan
Country [190] 0 0
China
State/province [190] 0 0
Lanzhou
Country [191] 0 0
China
State/province [191] 0 0
Luzhou
Country [192] 0 0
China
State/province [192] 0 0
Nanchang
Country [193] 0 0
China
State/province [193] 0 0
Nanjing
Country [194] 0 0
China
State/province [194] 0 0
Shanghai
Country [195] 0 0
China
State/province [195] 0 0
Shenyang
Country [196] 0 0
China
State/province [196] 0 0
Shenzhen
Country [197] 0 0
China
State/province [197] 0 0
Siping
Country [198] 0 0
China
State/province [198] 0 0
Suzhou
Country [199] 0 0
China
State/province [199] 0 0
Tianjin
Country [200] 0 0
China
State/province [200] 0 0
Wenzhou
Country [201] 0 0
China
State/province [201] 0 0
Wuhan
Country [202] 0 0
China
State/province [202] 0 0
Xi'An
Country [203] 0 0
China
State/province [203] 0 0
Xuzhou
Country [204] 0 0
China
State/province [204] 0 0
Yanji
Country [205] 0 0
China
State/province [205] 0 0
Yueyang
Country [206] 0 0
China
State/province [206] 0 0
Zhanjiang
Country [207] 0 0
Colombia
State/province [207] 0 0
Armenia
Country [208] 0 0
Colombia
State/province [208] 0 0
Barranquilla
Country [209] 0 0
Colombia
State/province [209] 0 0
Bogota D.C.
Country [210] 0 0
Colombia
State/province [210] 0 0
Bogota
Country [211] 0 0
Colombia
State/province [211] 0 0
Cali
Country [212] 0 0
Colombia
State/province [212] 0 0
Cartagena
Country [213] 0 0
Colombia
State/province [213] 0 0
Espinal - Tolima
Country [214] 0 0
Colombia
State/province [214] 0 0
Floridablanca
Country [215] 0 0
Colombia
State/province [215] 0 0
Manizales
Country [216] 0 0
Colombia
State/province [216] 0 0
Medellin
Country [217] 0 0
Croatia
State/province [217] 0 0
Dubrovnik
Country [218] 0 0
Croatia
State/province [218] 0 0
Krapinske Toplice
Country [219] 0 0
Croatia
State/province [219] 0 0
Opatija
Country [220] 0 0
Croatia
State/province [220] 0 0
Rijeka
Country [221] 0 0
Croatia
State/province [221] 0 0
Slavonski Brod
Country [222] 0 0
Croatia
State/province [222] 0 0
Varazdin
Country [223] 0 0
Croatia
State/province [223] 0 0
Zagreb
Country [224] 0 0
Czechia
State/province [224] 0 0
Brno
Country [225] 0 0
Czechia
State/province [225] 0 0
Ceska Lipa
Country [226] 0 0
Czechia
State/province [226] 0 0
Cesky Krumlov
Country [227] 0 0
Czechia
State/province [227] 0 0
Hodonin
Country [228] 0 0
Czechia
State/province [228] 0 0
Hradec Kralove
Country [229] 0 0
Czechia
State/province [229] 0 0
Kladno
Country [230] 0 0
Czechia
State/province [230] 0 0
Kromeriz
Country [231] 0 0
Czechia
State/province [231] 0 0
Liberec
Country [232] 0 0
Czechia
State/province [232] 0 0
Marianske Lazne
Country [233] 0 0
Czechia
State/province [233] 0 0
Olomouc
Country [234] 0 0
Czechia
State/province [234] 0 0
Ostrava
Country [235] 0 0
Czechia
State/province [235] 0 0
Pardubice
Country [236] 0 0
Czechia
State/province [236] 0 0
Plzen
Country [237] 0 0
Czechia
State/province [237] 0 0
Praha 10
Country [238] 0 0
Czechia
State/province [238] 0 0
Praha 2
Country [239] 0 0
Czechia
State/province [239] 0 0
Praha 4
Country [240] 0 0
Czechia
State/province [240] 0 0
Praha 5 - Motol
Country [241] 0 0
Czechia
State/province [241] 0 0
Praha 5
Country [242] 0 0
Czechia
State/province [242] 0 0
Rakovnik
Country [243] 0 0
Czechia
State/province [243] 0 0
Zlin
Country [244] 0 0
Denmark
State/province [244] 0 0
Aabenraa
Country [245] 0 0
Denmark
State/province [245] 0 0
Aalborg
Country [246] 0 0
Denmark
State/province [246] 0 0
Aarhus N
Country [247] 0 0
Denmark
State/province [247] 0 0
Copenhagen
Country [248] 0 0
Denmark
State/province [248] 0 0
Glostrup
Country [249] 0 0
Denmark
State/province [249] 0 0
Hellerup
Country [250] 0 0
Denmark
State/province [250] 0 0
Herning
Country [251] 0 0
Denmark
State/province [251] 0 0
Hillerød
Country [252] 0 0
Denmark
State/province [252] 0 0
Holbaek
Country [253] 0 0
Denmark
State/province [253] 0 0
Hvidovre
Country [254] 0 0
Denmark
State/province [254] 0 0
Køge
Country [255] 0 0
Denmark
State/province [255] 0 0
Næstved
Country [256] 0 0
Denmark
State/province [256] 0 0
Odense C
Country [257] 0 0
Denmark
State/province [257] 0 0
Silkeborg
Country [258] 0 0
Denmark
State/province [258] 0 0
Slagelse
Country [259] 0 0
Denmark
State/province [259] 0 0
Vejle
Country [260] 0 0
Denmark
State/province [260] 0 0
Viborg
Country [261] 0 0
Estonia
State/province [261] 0 0
Pärnu
Country [262] 0 0
Estonia
State/province [262] 0 0
Tallinn
Country [263] 0 0
Estonia
State/province [263] 0 0
Tartu
Country [264] 0 0
Estonia
State/province [264] 0 0
Viljandimaa
Country [265] 0 0
Finland
State/province [265] 0 0
Helsinki
Country [266] 0 0
Finland
State/province [266] 0 0
Oulu
Country [267] 0 0
Finland
State/province [267] 0 0
Tampere
Country [268] 0 0
Finland
State/province [268] 0 0
Turku
Country [269] 0 0
France
State/province [269] 0 0
Besancon
Country [270] 0 0
France
State/province [270] 0 0
Brest Cedex
Country [271] 0 0
France
State/province [271] 0 0
Cambrai Cedex
Country [272] 0 0
France
State/province [272] 0 0
Clermont-Ferrand Cedex 1
Country [273] 0 0
France
State/province [273] 0 0
Compiegne
Country [274] 0 0
France
State/province [274] 0 0
Dijon
Country [275] 0 0
France
State/province [275] 0 0
Grenoble
Country [276] 0 0
France
State/province [276] 0 0
Limoges Cedex 1
Country [277] 0 0
France
State/province [277] 0 0
Marseille
Country [278] 0 0
France
State/province [278] 0 0
Massy
Country [279] 0 0
France
State/province [279] 0 0
Montfermeil
Country [280] 0 0
France
State/province [280] 0 0
Montpellier Cedex 5
Country [281] 0 0
France
State/province [281] 0 0
Nantes
Country [282] 0 0
France
State/province [282] 0 0
Nice Cedex 01
Country [283] 0 0
France
State/province [283] 0 0
Paris Cedex 12
Country [284] 0 0
France
State/province [284] 0 0
Paris
Country [285] 0 0
France
State/province [285] 0 0
Pau
Country [286] 0 0
France
State/province [286] 0 0
Pessac
Country [287] 0 0
France
State/province [287] 0 0
Rouen
Country [288] 0 0
France
State/province [288] 0 0
Strasbourg Cedex
Country [289] 0 0
Georgia
State/province [289] 0 0
Batumi
Country [290] 0 0
Georgia
State/province [290] 0 0
Kutaisi
Country [291] 0 0
Georgia
State/province [291] 0 0
Tbilisi
Country [292] 0 0
Germany
State/province [292] 0 0
Aachen
Country [293] 0 0
Germany
State/province [293] 0 0
Bad Krozingen
Country [294] 0 0
Germany
State/province [294] 0 0
Berlin
Country [295] 0 0
Germany
State/province [295] 0 0
Bernau
Country [296] 0 0
Germany
State/province [296] 0 0
Bielefeld
Country [297] 0 0
Germany
State/province [297] 0 0
Bonn
Country [298] 0 0
Germany
State/province [298] 0 0
Dortmund
Country [299] 0 0
Germany
State/province [299] 0 0
Dresden
Country [300] 0 0
Germany
State/province [300] 0 0
Eschweiler
Country [301] 0 0
Germany
State/province [301] 0 0
Essen
Country [302] 0 0
Germany
State/province [302] 0 0
Frankfurt Am Main
Country [303] 0 0
Germany
State/province [303] 0 0
Freiburg
Country [304] 0 0
Germany
State/province [304] 0 0
Halle/Saale
Country [305] 0 0
Germany
State/province [305] 0 0
Hamburg
Country [306] 0 0
Germany
State/province [306] 0 0
Hamm
Country [307] 0 0
Germany
State/province [307] 0 0
Haßloch
Country [308] 0 0
Germany
State/province [308] 0 0
Heidelberg
Country [309] 0 0
Germany
State/province [309] 0 0
Homburg/Saar
Country [310] 0 0
Germany
State/province [310] 0 0
Kassel
Country [311] 0 0
Germany
State/province [311] 0 0
Leipzig
Country [312] 0 0
Germany
State/province [312] 0 0
Limburg
Country [313] 0 0
Germany
State/province [313] 0 0
Lippstadt
Country [314] 0 0
Germany
State/province [314] 0 0
Lübeck
Country [315] 0 0
Germany
State/province [315] 0 0
Magdeburg
Country [316] 0 0
Germany
State/province [316] 0 0
Mainz
Country [317] 0 0
Germany
State/province [317] 0 0
Marburg
Country [318] 0 0
Germany
State/province [318] 0 0
Münster
Country [319] 0 0
Germany
State/province [319] 0 0
Nürnberg
Country [320] 0 0
Germany
State/province [320] 0 0
Peine
Country [321] 0 0
Germany
State/province [321] 0 0
Rotenburg An Der Fulda
Country [322] 0 0
Germany
State/province [322] 0 0
Rüdersdorf Bei Berlin
Country [323] 0 0
Germany
State/province [323] 0 0
Stuttgart
Country [324] 0 0
Germany
State/province [324] 0 0
Warendorf
Country [325] 0 0
Greece
State/province [325] 0 0
Athens
Country [326] 0 0
Greece
State/province [326] 0 0
Chios
Country [327] 0 0
Greece
State/province [327] 0 0
Haidari
Country [328] 0 0
Greece
State/province [328] 0 0
Heraklion
Country [329] 0 0
Greece
State/province [329] 0 0
Ioannina
Country [330] 0 0
Greece
State/province [330] 0 0
Marousi
Country [331] 0 0
Greece
State/province [331] 0 0
N. Ionia
Country [332] 0 0
Greece
State/province [332] 0 0
Patra
Country [333] 0 0
Greece
State/province [333] 0 0
Thessaloniki
Country [334] 0 0
Guatemala
State/province [334] 0 0
Guatemala
Country [335] 0 0
Hong Kong
State/province [335] 0 0
Hong Kong
Country [336] 0 0
Hong Kong
State/province [336] 0 0
Shatin, Nt
Country [337] 0 0
Hungary
State/province [337] 0 0
Balatonfüred
Country [338] 0 0
Hungary
State/province [338] 0 0
Budapest
Country [339] 0 0
Hungary
State/province [339] 0 0
Debrecen
Country [340] 0 0
Hungary
State/province [340] 0 0
Eger
Country [341] 0 0
Hungary
State/province [341] 0 0
Gyula
Country [342] 0 0
Hungary
State/province [342] 0 0
Pécs
Country [343] 0 0
Hungary
State/province [343] 0 0
Szeged
Country [344] 0 0
Hungary
State/province [344] 0 0
Szekesfehervar
Country [345] 0 0
Hungary
State/province [345] 0 0
Szombathely
Country [346] 0 0
Hungary
State/province [346] 0 0
Zalaegerszeg
Country [347] 0 0
India
State/province [347] 0 0
Ahmedabad
Country [348] 0 0
India
State/province [348] 0 0
Aurangabad
Country [349] 0 0
India
State/province [349] 0 0
Bangalore
Country [350] 0 0
India
State/province [350] 0 0
Belgaum
Country [351] 0 0
India
State/province [351] 0 0
Bikaner
Country [352] 0 0
India
State/province [352] 0 0
Chennai
Country [353] 0 0
India
State/province [353] 0 0
Delhi
Country [354] 0 0
India
State/province [354] 0 0
Gurgaon
Country [355] 0 0
India
State/province [355] 0 0
Hyderabad
Country [356] 0 0
India
State/province [356] 0 0
Jaipur
Country [357] 0 0
India
State/province [357] 0 0
Karad
Country [358] 0 0
India
State/province [358] 0 0
Karamsad
Country [359] 0 0
India
State/province [359] 0 0
Kochi
Country [360] 0 0
India
State/province [360] 0 0
Kolhapur
Country [361] 0 0
India
State/province [361] 0 0
Kolkata
Country [362] 0 0
India
State/province [362] 0 0
Ludhiana
Country [363] 0 0
India
State/province [363] 0 0
Mangalore
Country [364] 0 0
India
State/province [364] 0 0
Mumbai
Country [365] 0 0
India
State/province [365] 0 0
Mysore
Country [366] 0 0
India
State/province [366] 0 0
Nagpur
Country [367] 0 0
India
State/province [367] 0 0
Nashik
Country [368] 0 0
India
State/province [368] 0 0
New Delhi
Country [369] 0 0
India
State/province [369] 0 0
Panaji
Country [370] 0 0
India
State/province [370] 0 0
Pune
Country [371] 0 0
India
State/province [371] 0 0
Secunderabad, Hyderabad
Country [372] 0 0
India
State/province [372] 0 0
Secunderabad
Country [373] 0 0
India
State/province [373] 0 0
Surat
Country [374] 0 0
India
State/province [374] 0 0
Vijayawada
Country [375] 0 0
India
State/province [375] 0 0
Vijaywada
Country [376] 0 0
India
State/province [376] 0 0
Visakhapatnam
Country [377] 0 0
India
State/province [377] 0 0
Vishkhapattanam
Country [378] 0 0
India
State/province [378] 0 0
Wardha
Country [379] 0 0
Israel
State/province [379] 0 0
Afula
Country [380] 0 0
Israel
State/province [380] 0 0
Ashkelon
Country [381] 0 0
Israel
State/province [381] 0 0
Beer Sheva
Country [382] 0 0
Israel
State/province [382] 0 0
Haifa
Country [383] 0 0
Israel
State/province [383] 0 0
Holon
Country [384] 0 0
Israel
State/province [384] 0 0
Jerusalem
Country [385] 0 0
Israel
State/province [385] 0 0
Kfar Saba
Country [386] 0 0
Israel
State/province [386] 0 0
Nahariya
Country [387] 0 0
Israel
State/province [387] 0 0
Nazareth
Country [388] 0 0
Israel
State/province [388] 0 0
Petah-Tikva
Country [389] 0 0
Israel
State/province [389] 0 0
Rehovot
Country [390] 0 0
Israel
State/province [390] 0 0
Safed
Country [391] 0 0
Israel
State/province [391] 0 0
Tel Aviv
Country [392] 0 0
Israel
State/province [392] 0 0
Tel Hashomer
Country [393] 0 0
Israel
State/province [393] 0 0
Tiberias
Country [394] 0 0
Israel
State/province [394] 0 0
Tzrifin
Country [395] 0 0
Italy
State/province [395] 0 0
Augusta
Country [396] 0 0
Italy
State/province [396] 0 0
Bergamo
Country [397] 0 0
Italy
State/province [397] 0 0
Brescia
Country [398] 0 0
Italy
State/province [398] 0 0
Ferrara
Country [399] 0 0
Italy
State/province [399] 0 0
Forlì
Country [400] 0 0
Italy
State/province [400] 0 0
Livorno
Country [401] 0 0
Italy
State/province [401] 0 0
Massa
Country [402] 0 0
Italy
State/province [402] 0 0
Milano
Country [403] 0 0
Italy
State/province [403] 0 0
Monza
Country [404] 0 0
Italy
State/province [404] 0 0
Napoli
Country [405] 0 0
Italy
State/province [405] 0 0
Novara
Country [406] 0 0
Italy
State/province [406] 0 0
Osio Sotto
Country [407] 0 0
Italy
State/province [407] 0 0
Palermo
Country [408] 0 0
Italy
State/province [408] 0 0
Perugia
Country [409] 0 0
Italy
State/province [409] 0 0
Rho
Country [410] 0 0
Italy
State/province [410] 0 0
Rimini
Country [411] 0 0
Italy
State/province [411] 0 0
Roma
Country [412] 0 0
Italy
State/province [412] 0 0
Seriate
Country [413] 0 0
Italy
State/province [413] 0 0
Treviso
Country [414] 0 0
Italy
State/province [414] 0 0
Vittorio Veneto
Country [415] 0 0
Japan
State/province [415] 0 0
Amagasaki-Shi
Country [416] 0 0
Japan
State/province [416] 0 0
Fukuoka-Shi
Country [417] 0 0
Japan
State/province [417] 0 0
Hachioji-Shi
Country [418] 0 0
Japan
State/province [418] 0 0
Higashihiroshima-Shi
Country [419] 0 0
Japan
State/province [419] 0 0
Higashiibaraki-Gun
Country [420] 0 0
Japan
State/province [420] 0 0
Hiroshima-Shi
Country [421] 0 0
Japan
State/province [421] 0 0
Itabashi-Ku
Country [422] 0 0
Japan
State/province [422] 0 0
Izumisano-Shi
Country [423] 0 0
Japan
State/province [423] 0 0
Kanazawa-Shi
Country [424] 0 0
Japan
State/province [424] 0 0
Kitakyushu-Shi
Country [425] 0 0
Japan
State/province [425] 0 0
Kobe-Shi
Country [426] 0 0
Japan
State/province [426] 0 0
Koga-Shi
Country [427] 0 0
Japan
State/province [427] 0 0
Komatsu-Shi
Country [428] 0 0
Japan
State/province [428] 0 0
Komatsushima-Shi
Country [429] 0 0
Japan
State/province [429] 0 0
Kumamoto-Shi
Country [430] 0 0
Japan
State/province [430] 0 0
Kure-Shi
Country [431] 0 0
Japan
State/province [431] 0 0
Kurume-Shi
Country [432] 0 0
Japan
State/province [432] 0 0
Kusatsu-Shi
Country [433] 0 0
Japan
State/province [433] 0 0
Kyoto City
Country [434] 0 0
Japan
State/province [434] 0 0
Minato-Ku
Country [435] 0 0
Japan
State/province [435] 0 0
Morioka-Shi
Country [436] 0 0
Japan
State/province [436] 0 0
Nagoya-Shi
Country [437] 0 0
Japan
State/province [437] 0 0
Nerima-Ku
Country [438] 0 0
Japan
State/province [438] 0 0
Osaka-Shi
Country [439] 0 0
Japan
State/province [439] 0 0
Sagamihara-Shi
Country [440] 0 0
Japan
State/province [440] 0 0
Sapporo-Shi
Country [441] 0 0
Japan
State/province [441] 0 0
Shinagawa-Ku
Country [442] 0 0
Japan
State/province [442] 0 0
Suita-Shi
Country [443] 0 0
Japan
State/province [443] 0 0
Tokushima-Shi
Country [444] 0 0
Japan
State/province [444] 0 0
Urasoe-Shi
Country [445] 0 0
Japan
State/province [445] 0 0
Yokohama-Shi
Country [446] 0 0
Korea, Republic of
State/province [446] 0 0
Busan
Country [447] 0 0
Korea, Republic of
State/province [447] 0 0
Daegu
Country [448] 0 0
Korea, Republic of
State/province [448] 0 0
Goyang-Si
Country [449] 0 0
Korea, Republic of
State/province [449] 0 0
Gwangju
Country [450] 0 0
Korea, Republic of
State/province [450] 0 0
Seongnam
Country [451] 0 0
Korea, Republic of
State/province [451] 0 0
Seoul
Country [452] 0 0
Korea, Republic of
State/province [452] 0 0
Suwon
Country [453] 0 0
Korea, Republic of
State/province [453] 0 0
Wonju
Country [454] 0 0
Latvia
State/province [454] 0 0
Daugavpils
Country [455] 0 0
Latvia
State/province [455] 0 0
Liepaja
Country [456] 0 0
Latvia
State/province [456] 0 0
Riga
Country [457] 0 0
Latvia
State/province [457] 0 0
Ventspils
Country [458] 0 0
Lithuania
State/province [458] 0 0
Kaunas
Country [459] 0 0
Lithuania
State/province [459] 0 0
Klaipeda
Country [460] 0 0
Lithuania
State/province [460] 0 0
Vilnius
Country [461] 0 0
Macedonia, The Former Yugoslav Republic of
State/province [461] 0 0
Bitola
Country [462] 0 0
Macedonia, The Former Yugoslav Republic of
State/province [462] 0 0
Shtip
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Mykolaiv
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Ukraine
State/province [747] 0 0
Odesa
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Ukraine
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Odessa
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Ukraine
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Simferopol
Country [750] 0 0
Ukraine
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Sumy
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Ukraine
State/province [751] 0 0
Uzhgorod
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Ukraine
State/province [752] 0 0
Vinnitsya
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Ukraine
State/province [753] 0 0
Vinnytsia
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Ukraine
State/province [754] 0 0
Zaporizhia
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Ukraine
State/province [755] 0 0
Zhytomyr
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United Kingdom
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Basildon
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Birmingham
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Bournemouth
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Bradford
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Burton On Trent
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Chertsey
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Chesterfield
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United Kingdom
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Chichester
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Cumbria
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Dudley
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United Kingdom
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Harrow
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United Kingdom
State/province [768] 0 0
High Wycombe
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United Kingdom
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Hull
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United Kingdom
State/province [770] 0 0
London
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United Kingdom
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Manchester
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United Kingdom
State/province [772] 0 0
Newcastle Upon Tyne
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United Kingdom
State/province [773] 0 0
Northampton
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United Kingdom
State/province [774] 0 0
Peterborough
Country [775] 0 0
United Kingdom
State/province [775] 0 0
Plymouth
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United Kingdom
State/province [776] 0 0
Portadown
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United Kingdom
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Portsmouth
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United Kingdom
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Redhill
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United Kingdom
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Rhyl
Country [780] 0 0
United Kingdom
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Romford
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Rotherham
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United Kingdom
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Sheffield
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South Shields
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St Leonards
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United Kingdom
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Stoke-On-Trent
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United Kingdom
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Sunderland
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United Kingdom
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Truro
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United Kingdom
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Wigan
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United Kingdom
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Worcester

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Sanofi
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Regeneron Pharmaceuticals
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Primary Objective:

To compare the effect of alirocumab with placebo on the occurrence of cardiovascular (CV)
events (composite endpoint of coronary heart disease (CHD) death, non-fatal myocardial
infarction (MI), fatal and non-fatal ischemic stroke, unstable angina (UA) requiring
hospitalization) in participants who experienced an acute coronary syndrome (ACS) event 4 to
52 weeks prior to randomization and were treated with evidence-based medical and dietary
management of dyslipidemia.

Secondary Objectives:

- To evaluate the effect of alirocumab on secondary endpoints (any CHD event , major CHD
event, any CV event, composite of all cause mortality/non-fatal MI/non-fatal ischemic
stroke, CHD deaths, CV deaths, all cause mortality).

- To evaluate the safety and tolerability of alirocumab.

- To evaluate the effect of alirocumab on lipid parameters.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01663402
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Sciences & Operations
Address 0 0
Sanofi
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/NCT01663402