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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/NCT05754957




Registration number
NCT05754957
Ethics application status
Date submitted
23/02/2023
Date registered
6/03/2023
Date last updated
22/05/2024

Titles & IDs
Public title
A Study of Milvexian in Participants After a Recent Acute Coronary Syndrome
Scientific title
A Phase 3, Randomized, Double-blind, Placebo-controlled, Event-driven Study to Demonstrate the Efficacy and Safety of Milvexian, an Oral Factor XIa Inhibitor, After a Recent Acute Coronary Syndrome
Secondary ID [1] 0 0
70033093ACS3003
Secondary ID [2] 0 0
CR109271
Universal Trial Number (UTN)
Trial acronym
LIBREXIA-ACS
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
Treatment: Drugs - Milvexian
Other interventions - Placebo

Experimental: Milvexian - Participants enrolled within 7 days of an acute coronary syndrome (ACS), who have undergone cardiac catheterization with percutaneous intervention (PCI) or who are being managed conservatively with or without catheterization, and who are receiving antiplatelet therapy standard-of-care (single antiplatelet therapy [SAPT] or dual antiplatelet therapy [DAPT]) as determined by the investigator will receive milvexian 25 milligrams (mg), orally, twice daily.

Placebo Comparator: Placebo - Participants enrolled within 7 days of an ACS, who have undergone cardiac catheterization with PCI or who are being managed conservatively with or without catheterization, and who are receiving antiplatelet therapy standard-of-care (SAPT or DAPT) as determined by the investigator will receive placebo orally, twice daily.


Treatment: Drugs: Milvexian
Milvexian will be administered orally.

Other interventions: Placebo
Placebo will be administered orally.
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Time to First Occurrence of Major Adverse Cardiovascular Event (MACE)
Timepoint [1] 0 0
Up to 3 years 6 months
Secondary outcome [1] 0 0
Time to the First Occurrence of Major Adverse Vascular Event (MAVE)
Timepoint [1] 0 0
Up to 3 years 6 months
Secondary outcome [2] 0 0
Time to the First Occurrence of Composite of All-cause Mortality (ACM), Myocardial Infarction (MI) and Ischemic Stroke
Timepoint [2] 0 0
Up to 3 years 6 months
Secondary outcome [3] 0 0
Time to Cardiovascular (CV) Death
Timepoint [3] 0 0
Up to 3 years 6 months
Secondary outcome [4] 0 0
Time to All-cause Mortality (ACM)
Timepoint [4] 0 0
Up to 3 years 6 months

Eligibility
Key inclusion criteria
- Participants must have an index event that meets all 3 of the following criteria
within 7 days prior to randomization: a) clinical syndrome consistent with spontaneous
cardiac ischemia, b) diagnosis of acute coronary syndrome (ACS) (that is, ST-elevation
myocardial infarction [STEMI], non-STEMI, or unstable angina [UA]), c) cardiac
biomarker elevation (example, troponin I, troponin T, creatine kinase-MB [CK-MB])
above the upper limit of normal as determined by the local laboratory

- Participants must have at least 2 of the following risk factors:a) age 65 or older, b)
diabetes mellitus, c) history of a prior myocardial infarction (MI) (other than index
ACS event), d) multivessel coronary artery disease (CAD), e) history of coronary
artery bypass graft (CABG) surgery prior to index ACS event, f) history of peripheral
artery disease (PAD) or cerebrovascular disease (example, carotid atherosclerosis,
intracranial artery stenosis, g) conservative management (that is, no percutaneous
intervention [PCI] or CABG after index ACS event), h) Any one or more of the following
high-risk angiographic features i) total stent length of greater than (>) 30
millimeters (mm), ii) thrombotic target lesion, iii) bifurcation lesion treated with
more than one stent, iv) calcified target lesion treated with atherectomy, v)
treatment of obstructive left main or proximal left anterior descending artery for
index ACS (or clinical diagnosis of an anterior STEMI)

- All female participants of childbearing potential must have a negative highly
sensitive serum beta-human chorionic gonadotropin (hCG) or urine test at screening

- A female participant must not be pregnant, breastfeeding, or planning to become
pregnant until 4 days (5 half-lives) after the last dose of study intervention
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- MI secondary to ischemia due to either increased oxygen demand or decreased supply
(Type 2 MI) or periprocedural MI as the index ACS event

- Planned CABG or staged PCI after randomization

- Any condition that requires chronic anticoagulation at the discretion of the
investigator and/or local guidelines

- Conditions with a significant increased risk of bleeding (example, clinically
significant bleeding within previous 3 months, known bleeding diathesis, et cetera)

Study design
Purpose of the study
Treatment
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
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
7/04/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
19/10/2026
Actual
Sample size
Target
16000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Flinders Medical Centre - Adelaide
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Ballarat Base Hospital - Ballarat
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Sunshine Coast University Hospital - Birtinya
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Cairns Base Hospital - Cairns
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Royal Prince Alfred Hospital - Camperdown
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Concord Repatriation General Hospital - Concord
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Royal Brisbane and Women's Hospital - Herston
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Royal Hobart Hospital - Hobart
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Nepean Hospital - Kingswood
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Core Research Group - Milton
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Fiona Stanley Hospital - Murdoch
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5042 - Adelaide
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3350 - Ballarat
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4575 - Birtinya
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4870 - Cairns
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2050 - Camperdown
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2139 - Concord
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4029 - Herston
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7000 - Hobart
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2747 - Kingswood
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4064 - Milton
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6150 - Murdoch
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Bonn
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Germany
State/province [210] 0 0
Dortmund
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Germany
State/province [211] 0 0
Dresden
Country [212] 0 0
Germany
State/province [212] 0 0
Erfurt
Country [213] 0 0
Germany
State/province [213] 0 0
Greifswald
Country [214] 0 0
Germany
State/province [214] 0 0
Hamburg
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Germany
State/province [215] 0 0
Leverkusen
Country [216] 0 0
Germany
State/province [216] 0 0
Ludwigshafen
Country [217] 0 0
Germany
State/province [217] 0 0
Luedenscheid
Country [218] 0 0
Germany
State/province [218] 0 0
Mainz
Country [219] 0 0
Germany
State/province [219] 0 0
Moenchengladbach
Country [220] 0 0
Germany
State/province [220] 0 0
Neuwied
Country [221] 0 0
Germany
State/province [221] 0 0
Remscheid
Country [222] 0 0
Germany
State/province [222] 0 0
Worms
Country [223] 0 0
Greece
State/province [223] 0 0
Athens
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Greece
State/province [224] 0 0
Ioannina
Country [225] 0 0
Greece
State/province [225] 0 0
Thessaloniki
Country [226] 0 0
Hungary
State/province [226] 0 0
Budapest
Country [227] 0 0
Hungary
State/province [227] 0 0
Debrecen
Country [228] 0 0
Hungary
State/province [228] 0 0
Kaposvar
Country [229] 0 0
Hungary
State/province [229] 0 0
Kecskemet
Country [230] 0 0
Hungary
State/province [230] 0 0
Szeged
Country [231] 0 0
Hungary
State/province [231] 0 0
Szekszárd
Country [232] 0 0
Hungary
State/province [232] 0 0
Szombathely
Country [233] 0 0
India
State/province [233] 0 0
Bangalore
Country [234] 0 0
India
State/province [234] 0 0
Belgaum
Country [235] 0 0
India
State/province [235] 0 0
Chennai
Country [236] 0 0
India
State/province [236] 0 0
Cochin
Country [237] 0 0
India
State/province [237] 0 0
Delhi
Country [238] 0 0
India
State/province [238] 0 0
Hyderabad
Country [239] 0 0
India
State/province [239] 0 0
Hyderbad
Country [240] 0 0
India
State/province [240] 0 0
Kolkata
Country [241] 0 0
India
State/province [241] 0 0
Ludhiana
Country [242] 0 0
India
State/province [242] 0 0
Mangalore
Country [243] 0 0
India
State/province [243] 0 0
Nagpur
Country [244] 0 0
India
State/province [244] 0 0
New Delhi
Country [245] 0 0
India
State/province [245] 0 0
Pune
Country [246] 0 0
India
State/province [246] 0 0
Shimoga
Country [247] 0 0
India
State/province [247] 0 0
Surat
Country [248] 0 0
Israel
State/province [248] 0 0
Afula
Country [249] 0 0
Israel
State/province [249] 0 0
Ashdod
Country [250] 0 0
Israel
State/province [250] 0 0
Beersheba
Country [251] 0 0
Israel
State/province [251] 0 0
Haifa
Country [252] 0 0
Israel
State/province [252] 0 0
Jerusalem
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Israel
State/province [253] 0 0
Kfar-Sava
Country [254] 0 0
Israel
State/province [254] 0 0
Naharya
Country [255] 0 0
Israel
State/province [255] 0 0
Petah Tikva
Country [256] 0 0
Israel
State/province [256] 0 0
Ramat Gan
Country [257] 0 0
Israel
State/province [257] 0 0
Rechovot
Country [258] 0 0
Israel
State/province [258] 0 0
Rishon Lezion
Country [259] 0 0
Israel
State/province [259] 0 0
Safed
Country [260] 0 0
Italy
State/province [260] 0 0
Alessandria
Country [261] 0 0
Italy
State/province [261] 0 0
Bergamo
Country [262] 0 0
Italy
State/province [262] 0 0
Bologna
Country [263] 0 0
Italy
State/province [263] 0 0
Chieti
Country [264] 0 0
Italy
State/province [264] 0 0
La Spezia
Country [265] 0 0
Italy
State/province [265] 0 0
Mestre
Country [266] 0 0
Italy
State/province [266] 0 0
Milano
Country [267] 0 0
Italy
State/province [267] 0 0
Napoli
Country [268] 0 0
Italy
State/province [268] 0 0
Parma
Country [269] 0 0
Italy
State/province [269] 0 0
Pavia
Country [270] 0 0
Italy
State/province [270] 0 0
Pisa
Country [271] 0 0
Italy
State/province [271] 0 0
Roma
Country [272] 0 0
Italy
State/province [272] 0 0
Rozzano
Country [273] 0 0
Italy
State/province [273] 0 0
Sassari
Country [274] 0 0
Italy
State/province [274] 0 0
Seriate
Country [275] 0 0
Italy
State/province [275] 0 0
Sesto San Giovanni
Country [276] 0 0
Italy
State/province [276] 0 0
Torrette Di Ancona
Country [277] 0 0
Italy
State/province [277] 0 0
Treviglio
Country [278] 0 0
Japan
State/province [278] 0 0
Aichi
Country [279] 0 0
Japan
State/province [279] 0 0
Amagasaki shi
Country [280] 0 0
Japan
State/province [280] 0 0
Chiba
Country [281] 0 0
Japan
State/province [281] 0 0
Chikushino-shi
Country [282] 0 0
Japan
State/province [282] 0 0
Fukui-shi
Country [283] 0 0
Japan
State/province [283] 0 0
Fukuoka-shi
Country [284] 0 0
Japan
State/province [284] 0 0
Fukuoka
Country [285] 0 0
Japan
State/province [285] 0 0
Gifu
Country [286] 0 0
Japan
State/province [286] 0 0
Gunma
Country [287] 0 0
Japan
State/province [287] 0 0
Himeji-shi
Country [288] 0 0
Japan
State/province [288] 0 0
Hiratsuka-shi
Country [289] 0 0
Japan
State/province [289] 0 0
Hirosaki
Country [290] 0 0
Japan
State/province [290] 0 0
Hiroshima
Country [291] 0 0
Japan
State/province [291] 0 0
Isehara
Country [292] 0 0
Japan
State/province [292] 0 0
Ishikawa
Country [293] 0 0
Japan
State/province [293] 0 0
Itabashi Ku
Country [294] 0 0
Japan
State/province [294] 0 0
Izunokuni-shi
Country [295] 0 0
Japan
State/province [295] 0 0
Kamogawa
Country [296] 0 0
Japan
State/province [296] 0 0
Kanagawa
Country [297] 0 0
Japan
State/province [297] 0 0
Kanazawa-shi
Country [298] 0 0
Japan
State/province [298] 0 0
Kasuga-shi
Country [299] 0 0
Japan
State/province [299] 0 0
Kisarazu-shi
Country [300] 0 0
Japan
State/province [300] 0 0
Kitakyushu-shi
Country [301] 0 0
Japan
State/province [301] 0 0
Kochi
Country [302] 0 0
Japan
State/province [302] 0 0
Koga
Country [303] 0 0
Japan
State/province [303] 0 0
Kumamoto-shi
Country [304] 0 0
Japan
State/province [304] 0 0
Kurashiki
Country [305] 0 0
Japan
State/province [305] 0 0
Kure-shi
Country [306] 0 0
Japan
State/province [306] 0 0
Kyoto-shi
Country [307] 0 0
Japan
State/province [307] 0 0
Kyoto
Country [308] 0 0
Japan
State/province [308] 0 0
Matsudo-shi
Country [309] 0 0
Japan
State/province [309] 0 0
Matsumoto-shi
Country [310] 0 0
Japan
State/province [310] 0 0
Meguro-ku
Country [311] 0 0
Japan
State/province [311] 0 0
Minato-ku
Country [312] 0 0
Japan
State/province [312] 0 0
Miyazaki-shi
Country [313] 0 0
Japan
State/province [313] 0 0
Nagoya-shi
Country [314] 0 0
Japan
State/province [314] 0 0
Nishinomiya-shi
Country [315] 0 0
Japan
State/province [315] 0 0
Okayama shi
Country [316] 0 0
Japan
State/province [316] 0 0
Osaka-shi
Country [317] 0 0
Japan
State/province [317] 0 0
Osaka
Country [318] 0 0
Japan
State/province [318] 0 0
Sagamihara
Country [319] 0 0
Japan
State/province [319] 0 0
Saga
Country [320] 0 0
Japan
State/province [320] 0 0
Saitama-shi
Country [321] 0 0
Japan
State/province [321] 0 0
Saitama
Country [322] 0 0
Japan
State/province [322] 0 0
Sendai
Country [323] 0 0
Japan
State/province [323] 0 0
Shinagawa
Country [324] 0 0
Japan
State/province [324] 0 0
Shinjuku-ku
Country [325] 0 0
Japan
State/province [325] 0 0
Shiwa-gun
Country [326] 0 0
Japan
State/province [326] 0 0
Suita-Shi
Country [327] 0 0
Japan
State/province [327] 0 0
Takamatsu
Country [328] 0 0
Japan
State/province [328] 0 0
Tokushima
Country [329] 0 0
Japan
State/province [329] 0 0
Tokyo
Country [330] 0 0
Japan
State/province [330] 0 0
Toyama-shi
Country [331] 0 0
Japan
State/province [331] 0 0
Tsuchiura-City
Country [332] 0 0
Japan
State/province [332] 0 0
Tsukuba shi
Country [333] 0 0
Japan
State/province [333] 0 0
Tsu
Country [334] 0 0
Japan
State/province [334] 0 0
Ube
Country [335] 0 0
Japan
State/province [335] 0 0
Urayasu-shi
Country [336] 0 0
Japan
State/province [336] 0 0
Ureshino-shi
Country [337] 0 0
Japan
State/province [337] 0 0
Wakayama
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Japan
State/province [338] 0 0
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Korea, Republic of
State/province [339] 0 0
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Korea, Republic of
State/province [340] 0 0
Cheongju-si
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Korea, Republic of
State/province [341] 0 0
Chuncheon
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Korea, Republic of
State/province [342] 0 0
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Korea, Republic of
State/province [343] 0 0
Daejeon
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Korea, Republic of
State/province [344] 0 0
Gangseo-gu
Country [345] 0 0
Korea, Republic of
State/province [345] 0 0
Goyang-si
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Korea, Republic of
State/province [346] 0 0
Gwangju
Country [347] 0 0
Korea, Republic of
State/province [347] 0 0
Gyeonggi-do
Country [348] 0 0
Korea, Republic of
State/province [348] 0 0
Incheon
Country [349] 0 0
Korea, Republic of
State/province [349] 0 0
Sejong-si
Country [350] 0 0
Korea, Republic of
State/province [350] 0 0
Seoul
Country [351] 0 0
Korea, Republic of
State/province [351] 0 0
Wonju
Country [352] 0 0
Korea, Republic of
State/province [352] 0 0
Yangsan Si
Country [353] 0 0
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Daugavpils
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Latvia
State/province [354] 0 0
Riga
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Lithuania
State/province [355] 0 0
Kaunas
Country [356] 0 0
Lithuania
State/province [356] 0 0
Klaipeda
Country [357] 0 0
Lithuania
State/province [357] 0 0
Vilnius
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Malaysia
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Kota Bharu
Country [359] 0 0
Malaysia
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Kota Kinabalu
Country [360] 0 0
Malaysia
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Kuala Lumpur
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Malaysia
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Kuching
Country [362] 0 0
Malaysia
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Miri
Country [363] 0 0
Malaysia
State/province [363] 0 0
Seberang Jaya
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Malaysia
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Selayang
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Netherlands
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Alkmaar
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Netherlands
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Almelo
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Netherlands
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Amersfoort
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Netherlands
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Amsterdam
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Netherlands
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Deventer
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Netherlands
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Ede
Country [371] 0 0
Netherlands
State/province [371] 0 0
Eindhoven
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Netherlands
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Emmen
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Netherlands
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Enschede
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Netherlands
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Netherlands
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Gouda
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Netherlands
State/province [376] 0 0
Harderwijk
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Netherlands
State/province [377] 0 0
Heerlen
Country [378] 0 0
Netherlands
State/province [378] 0 0
Helmond
Country [379] 0 0
Netherlands
State/province [379] 0 0
Leiderdorp
Country [380] 0 0
Netherlands
State/province [380] 0 0
Maastricht
Country [381] 0 0
Netherlands
State/province [381] 0 0
Nieuwegein
Country [382] 0 0
Netherlands
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Nijmegen
Country [383] 0 0
Netherlands
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Roosendaal
Country [384] 0 0
Netherlands
State/province [384] 0 0
Rotterdam
Country [385] 0 0
Netherlands
State/province [385] 0 0
s-Hertogenbosch
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Netherlands
State/province [386] 0 0
Sneek
Country [387] 0 0
Netherlands
State/province [387] 0 0
Tiel
Country [388] 0 0
Netherlands
State/province [388] 0 0
Utrecht
Country [389] 0 0
Netherlands
State/province [389] 0 0
Veldhoven
Country [390] 0 0
Netherlands
State/province [390] 0 0
Venlo
Country [391] 0 0
Netherlands
State/province [391] 0 0
Zutphen
Country [392] 0 0
New Zealand
State/province [392] 0 0
Auckland
Country [393] 0 0
New Zealand
State/province [393] 0 0
Christchurch
Country [394] 0 0
New Zealand
State/province [394] 0 0
Dunedin
Country [395] 0 0
New Zealand
State/province [395] 0 0
Hastings
Country [396] 0 0
New Zealand
State/province [396] 0 0
New Plymouth
Country [397] 0 0
New Zealand
State/province [397] 0 0
Otahuhu
Country [398] 0 0
New Zealand
State/province [398] 0 0
Rotorua
Country [399] 0 0
New Zealand
State/province [399] 0 0
Tauranga
Country [400] 0 0
New Zealand
State/province [400] 0 0
Whangarei
Country [401] 0 0
Poland
State/province [401] 0 0
Bydgoszcz
Country [402] 0 0
Poland
State/province [402] 0 0
Bytom
Country [403] 0 0
Poland
State/province [403] 0 0
Elblag
Country [404] 0 0
Poland
State/province [404] 0 0
Katowice
Country [405] 0 0
Poland
State/province [405] 0 0
Kielce
Country [406] 0 0
Poland
State/province [406] 0 0
Krakow
Country [407] 0 0
Poland
State/province [407] 0 0
Lublin
Country [408] 0 0
Poland
State/province [408] 0 0
Naleczow
Country [409] 0 0
Poland
State/province [409] 0 0
Olsztyn
Country [410] 0 0
Poland
State/province [410] 0 0
Oswiecim
Country [411] 0 0
Poland
State/province [411] 0 0
Przemysl
Country [412] 0 0
Poland
State/province [412] 0 0
Siedlce
Country [413] 0 0
Poland
State/province [413] 0 0
Skierniewice
Country [414] 0 0
Poland
State/province [414] 0 0
Sopot
Country [415] 0 0
Poland
State/province [415] 0 0
Torun
Country [416] 0 0
Poland
State/province [416] 0 0
Warszawa
Country [417] 0 0
Poland
State/province [417] 0 0
Walbrzych
Country [418] 0 0
Poland
State/province [418] 0 0
Wroclaw
Country [419] 0 0
Portugal
State/province [419] 0 0
Aveiro
Country [420] 0 0
Portugal
State/province [420] 0 0
Braga
Country [421] 0 0
Portugal
State/province [421] 0 0
Covilha
Country [422] 0 0
Portugal
State/province [422] 0 0
Guimarães
Country [423] 0 0
Portugal
State/province [423] 0 0
Lisboa
Country [424] 0 0
Portugal
State/province [424] 0 0
Lisbon
Country [425] 0 0
Portugal
State/province [425] 0 0
Santa Maria da Feira
Country [426] 0 0
Portugal
State/province [426] 0 0
Vila Nova de Gaia
Country [427] 0 0
Portugal
State/province [427] 0 0
Vila Real
Country [428] 0 0
Romania
State/province [428] 0 0
Baia-Mare
Country [429] 0 0
Romania
State/province [429] 0 0
Brasov
Country [430] 0 0
Romania
State/province [430] 0 0
Bucharest
Country [431] 0 0
Romania
State/province [431] 0 0
Bucuresti
Country [432] 0 0
Romania
State/province [432] 0 0
Cluj-Napoca
Country [433] 0 0
Romania
State/province [433] 0 0
Constanta
Country [434] 0 0
Romania
State/province [434] 0 0
Craiova
Country [435] 0 0
Romania
State/province [435] 0 0
Iasi
Country [436] 0 0
Romania
State/province [436] 0 0
Oradea
Country [437] 0 0
Romania
State/province [437] 0 0
Pitesti
Country [438] 0 0
Romania
State/province [438] 0 0
Targu-Mures
Country [439] 0 0
Romania
State/province [439] 0 0
Tg. Mures
Country [440] 0 0
Romania
State/province [440] 0 0
Timisoara
Country [441] 0 0
Serbia
State/province [441] 0 0
Belgrade
Country [442] 0 0
Serbia
State/province [442] 0 0
Kragujevac
Country [443] 0 0
Serbia
State/province [443] 0 0
Niska Banja
Country [444] 0 0
Serbia
State/province [444] 0 0
Nis
Country [445] 0 0
Serbia
State/province [445] 0 0
Pancevo
Country [446] 0 0
Serbia
State/province [446] 0 0
Smederevo
Country [447] 0 0
Serbia
State/province [447] 0 0
Sremska Mitrovica
Country [448] 0 0
Serbia
State/province [448] 0 0
Zajecar
Country [449] 0 0
Slovakia
State/province [449] 0 0
Banska Bystrica
Country [450] 0 0
Slovakia
State/province [450] 0 0
Bardejov
Country [451] 0 0
Slovakia
State/province [451] 0 0
Bratislava
Country [452] 0 0
Slovakia
State/province [452] 0 0
Brezno
Country [453] 0 0
Slovakia
State/province [453] 0 0
Kosice
Country [454] 0 0
Slovakia
State/province [454] 0 0
Košice
Country [455] 0 0
Slovakia
State/province [455] 0 0
Lucenec
Country [456] 0 0
Slovakia
State/province [456] 0 0
Martin
Country [457] 0 0
Slovakia
State/province [457] 0 0
Moldava nad Bodvou
Country [458] 0 0
Slovakia
State/province [458] 0 0
Nitra
Country [459] 0 0
Slovakia
State/province [459] 0 0
Nove Zamky
Country [460] 0 0
Slovakia
State/province [460] 0 0
Svidnik
Country [461] 0 0
Slovakia
State/province [461] 0 0
Zilina
Country [462] 0 0
Slovakia
State/province [462] 0 0
Zvolen
Country [463] 0 0
South Africa
State/province [463] 0 0
Cape Town
Country [464] 0 0
South Africa
State/province [464] 0 0
Centurion
Country [465] 0 0
South Africa
State/province [465] 0 0
Durban
Country [466] 0 0
South Africa
State/province [466] 0 0
Johannesburg
Country [467] 0 0
South Africa
State/province [467] 0 0
Somerset West
Country [468] 0 0
South Africa
State/province [468] 0 0
Worcester
Country [469] 0 0
Spain
State/province [469] 0 0
Alicante
Country [470] 0 0
Spain
State/province [470] 0 0
Barcelona
Country [471] 0 0
Spain
State/province [471] 0 0
El Palmar
Country [472] 0 0
Spain
State/province [472] 0 0
Lleida
Country [473] 0 0
Spain
State/province [473] 0 0
Madrid
Country [474] 0 0
Spain
State/province [474] 0 0
Malaga
Country [475] 0 0
Spain
State/province [475] 0 0
Manises
Country [476] 0 0
Spain
State/province [476] 0 0
Pamplona
Country [477] 0 0
Spain
State/province [477] 0 0
Santiago de Compostela
Country [478] 0 0
Spain
State/province [478] 0 0
Tarragona
Country [479] 0 0
Spain
State/province [479] 0 0
Valencia
Country [480] 0 0
Spain
State/province [480] 0 0
Vigo
Country [481] 0 0
Switzerland
State/province [481] 0 0
Basel
Country [482] 0 0
Switzerland
State/province [482] 0 0
Bern
Country [483] 0 0
Switzerland
State/province [483] 0 0
Geneve 14
Country [484] 0 0
Switzerland
State/province [484] 0 0
Lugano
Country [485] 0 0
Switzerland
State/province [485] 0 0
Zuerich
Country [486] 0 0
Taiwan
State/province [486] 0 0
Changhua
Country [487] 0 0
Taiwan
State/province [487] 0 0
Kaohsiung
Country [488] 0 0
Taiwan
State/province [488] 0 0
New Taipei
Country [489] 0 0
Taiwan
State/province [489] 0 0
Taichung
Country [490] 0 0
Taiwan
State/province [490] 0 0
Tainan
Country [491] 0 0
Taiwan
State/province [491] 0 0
Taipei City
Country [492] 0 0
Taiwan
State/province [492] 0 0
Taipei
Country [493] 0 0
Taiwan
State/province [493] 0 0
Taoyuan County
Country [494] 0 0
Taiwan
State/province [494] 0 0
Yilan County
Country [495] 0 0
Thailand
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Yeovil

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Janssen Research & Development, LLC
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Bristol-Myers Squibb
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to evaluate that milvexian is superior to placebo, in addition
to standard-of-care, in reducing the risk of major adverse cardiovascular event (MACE) (the
composite of cardiovascular [CV] death, myocardial infarction [MI], and ischemic stroke).
Trial website
https://clinicaltrials.gov/ct2/show/NCT05754957
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Janssen Research & Development, LLC Clinical Trial
Address 0 0
Janssen Research & Development, LLC
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Study Contact
Address 0 0
Country 0 0
Phone 0 0
844-434-4210
Fax 0 0
Email 0 0
Participate-In-This-Study@its.jnj.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05754957