Trial Review

Technical difficulties have been reported by some users of the search function and is being investigated by technical staff. Thank you for your patience and apologies for any inconvenience caused.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05686070




Registration number
NCT05686070
Ethics application status
Date submitted
6/01/2023
Date registered
17/01/2023
Date last updated
29/05/2024

Titles & IDs
Public title
A Study to Test Asundexian for Preventing a Stroke Caused by a Clot in Participants After an Acute Ischemic Stroke or After a High-risk Transient Ischemic Attack, a So-called Mini Stroke
Scientific title
A Multicenter, International, Randomized, Placebo Controlled, Double-blind, Parallel Group and Event Driven Phase 3 Study of the Oral FXIa Inhibitor Asundexian (BAY 2433334) for the Prevention of Ischemic Stroke in Male and Female Participants Aged 18 Years and Older After an Acute Non-cardioembolic Ischemic Stroke or High-risk TIA
Secondary ID [1] 0 0
2023-503793-20-00
Secondary ID [2] 0 0
20604
Universal Trial Number (UTN)
Trial acronym
OCEANIC-STROKE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prevention of Ischemic Stroke 0 0
Acute Non-cardioembolic Ischemic Stroke 0 0
High-risk Transient Ischemic Attack 0 0
Condition category
Condition code
Stroke 0 0 0 0
Haemorrhagic
Stroke 0 0 0 0
Ischaemic
Neurological 0 0 0 0
Other neurological disorders
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 - Asundexian (BAY2433334)
Treatment: Drugs - Placebo

Experimental: Asundexian - Participants will receive asundexian.

Placebo Comparator: Placebo - Participants will receive placebo.


Treatment: Drugs: Asundexian (BAY2433334)
Once daily, oral

Treatment: Drugs: Placebo
Placebo to asundexian, once daily, oral
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Time to first occurrence of ischemic stroke
Timepoint [1] 0 0
Up to 31 months
Primary outcome [2] 0 0
Time to first occurrence of ISTH major bleeding
Timepoint [2] 0 0
Up to 31 months
Secondary outcome [1] 0 0
Time to first occurrence of all strokes (ischemic and hemorrhagic)
Timepoint [1] 0 0
Up to 31 months
Secondary outcome [2] 0 0
Time to first occurrence of composite of CV death, MI or stroke
Timepoint [2] 0 0
Up to 31 months
Secondary outcome [3] 0 0
Time to first occurrence of composite of all-cause mortality, MI or stroke
Timepoint [3] 0 0
Up to 31 months
Secondary outcome [4] 0 0
Time to first occurrence of disabling stroke (mRS =3 at 90 days)
Timepoint [4] 0 0
Up to 31 months
Secondary outcome [5] 0 0
Time to first occurrence of all-cause mortality
Timepoint [5] 0 0
Up to 31 months
Secondary outcome [6] 0 0
Time to first occurrence of transient ischemic attack (TIA)
Timepoint [6] 0 0
Up to 31 months
Secondary outcome [7] 0 0
Time to first occurrence of composite of ISTH major or clinically relevant non-major bleeding
Timepoint [7] 0 0
Up to 31 months
Secondary outcome [8] 0 0
Time to first occurrence of ISTH clinically relevant non-major bleeding
Timepoint [8] 0 0
Up to 31 months
Secondary outcome [9] 0 0
Time to first occurrence of symptomatic intracranial hemorrhage
Timepoint [9] 0 0
Up to 31 months
Secondary outcome [10] 0 0
Time to first occurrence of hemorrhagic stroke
Timepoint [10] 0 0
Up to 31 months
Secondary outcome [11] 0 0
Time to first occurrence of fatal bleeding
Timepoint [11] 0 0
Up to 31 months
Secondary outcome [12] 0 0
Time to first occurrence of minor bleeding
Timepoint [12] 0 0
Up to 31 months
Secondary outcome [13] 0 0
Time to first occurrence of composite of ischemic stroke or ISTH major bleeding
Timepoint [13] 0 0
Up to 31 months
Secondary outcome [14] 0 0
Time to first occurrence of composite of CV death, all stroke, MI or ISTH major bleeding
Timepoint [14] 0 0
Up to 31 months
Secondary outcome [15] 0 0
Time to first occurrence of composite of all-cause mortality, disabling stroke, fatal bleeding, symptomatic intracranial hemorrhage
Timepoint [15] 0 0
Up to 31 months
Secondary outcome [16] 0 0
Time to first occurrence of ischemic stroke in the first 90 days
Timepoint [16] 0 0
Up to 31 months

Eligibility
Key inclusion criteria
- Participants must be = 18 years of age

- Acute non-cardioembolic stroke or high-risk TIA

- Systemic or cerebrovascular atherosclerosis or acute non-lacunar infarct
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Ischemic stroke = 7 days before the index event

- Index stroke following procedures or strokes due to other rare causes

- History of atrial fibrillation/flutter, left ventricular thrombus, mechanic valve or
other cardioembolic source of stroke requiring anticoagulation

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
26/01/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
10/10/2025
Actual
Sample size
Target
9300
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Blacktown Hospital - Blacktownn
Recruitment hospital [2] 0 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [3] 0 0
South Western Sydney Local Health District | Liverpool Hospital - Stroke and Neurovascular Department - Liverpool
Recruitment hospital [4] 0 0
John Hunter Hospital - New Lambton Heights
Recruitment hospital [5] 0 0
Prince of Wales Hospital NSW - Randwick
Recruitment hospital [6] 0 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [7] 0 0
Nepean Hospital - Sydney
Recruitment hospital [8] 0 0
Westmead Hospital - Westmead
Recruitment hospital [9] 0 0
Sunshine Coast University Hospital - Birtinya
Recruitment hospital [10] 0 0
Royal Brisbane and Women's Hospital - Brisbane
Recruitment hospital [11] 0 0
Redcliffe District Hospital - Redcliffe
Recruitment hospital [12] 0 0
Gold Coast University Hospital - Southport
Recruitment hospital [13] 0 0
Princess Alexandra Hospital Australia - Woollongabba
Recruitment hospital [14] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [15] 0 0
Lyell McEwin Hospital - Elizabeth Vale
Recruitment hospital [16] 0 0
Grampians Health Ballarat - Ballarat
Recruitment hospital [17] 0 0
Eastern Health Box Hill Hospital - Box Hill
Recruitment hospital [18] 0 0
Monash Medical Centre - Clayton
Recruitment hospital [19] 0 0
Royal Melbourne Hospital - Parkville
Recruitment hospital [20] 0 0
The Alfred Hospital - Prahran
Recruitment hospital [21] 0 0
Western Health Neuroscience Research Unit - St Albans
Recruitment hospital [22] 0 0
Fiona Stanley Hospital - Murdoch
Recruitment hospital [23] 0 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment postcode(s) [1] 0 0
2148 - Blacktownn
Recruitment postcode(s) [2] 0 0
2050 - Camperdown
Recruitment postcode(s) [3] 0 0
2170 - Liverpool
Recruitment postcode(s) [4] 0 0
2305 - New Lambton Heights
Recruitment postcode(s) [5] 0 0
2031 - Randwick
Recruitment postcode(s) [6] 0 0
2065 - St Leonards
Recruitment postcode(s) [7] 0 0
2751 - Sydney
Recruitment postcode(s) [8] 0 0
2145 - Westmead
Recruitment postcode(s) [9] 0 0
4575 - Birtinya
Recruitment postcode(s) [10] 0 0
4029 - Brisbane
Recruitment postcode(s) [11] 0 0
4020 - Redcliffe
Recruitment postcode(s) [12] 0 0
4215 - Southport
Recruitment postcode(s) [13] 0 0
4106 - Woollongabba
Recruitment postcode(s) [14] 0 0
5000 - Adelaide
Recruitment postcode(s) [15] 0 0
5112 - Elizabeth Vale
Recruitment postcode(s) [16] 0 0
3350 - Ballarat
Recruitment postcode(s) [17] 0 0
3128 - Box Hill
Recruitment postcode(s) [18] 0 0
3168 - Clayton
Recruitment postcode(s) [19] 0 0
3050 - Parkville
Recruitment postcode(s) [20] 0 0
3181 - Prahran
Recruitment postcode(s) [21] 0 0
3021 - St Albans
Recruitment postcode(s) [22] 0 0
6961 - Murdoch
Recruitment postcode(s) [23] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
Arkansas
Country [4] 0 0
United States of America
State/province [4] 0 0
California
Country [5] 0 0
United States of America
State/province [5] 0 0
Connecticut
Country [6] 0 0
United States of America
State/province [6] 0 0
Delaware
Country [7] 0 0
United States of America
State/province [7] 0 0
Florida
Country [8] 0 0
United States of America
State/province [8] 0 0
Illinois
Country [9] 0 0
United States of America
State/province [9] 0 0
Kentucky
Country [10] 0 0
United States of America
State/province [10] 0 0
Louisiana
Country [11] 0 0
United States of America
State/province [11] 0 0
Maryland
Country [12] 0 0
United States of America
State/province [12] 0 0
Massachusetts
Country [13] 0 0
United States of America
State/province [13] 0 0
Michigan
Country [14] 0 0
United States of America
State/province [14] 0 0
Minnesota
Country [15] 0 0
United States of America
State/province [15] 0 0
Mississippi
Country [16] 0 0
United States of America
State/province [16] 0 0
Missouri
Country [17] 0 0
United States of America
State/province [17] 0 0
New Hampshire
Country [18] 0 0
United States of America
State/province [18] 0 0
New Jersey
Country [19] 0 0
United States of America
State/province [19] 0 0
New York
Country [20] 0 0
United States of America
State/province [20] 0 0
North Carolina
Country [21] 0 0
United States of America
State/province [21] 0 0
Ohio
Country [22] 0 0
United States of America
State/province [22] 0 0
Oklahoma
Country [23] 0 0
United States of America
State/province [23] 0 0
Oregon
Country [24] 0 0
United States of America
State/province [24] 0 0
Pennsylvania
Country [25] 0 0
United States of America
State/province [25] 0 0
Rhode Island
Country [26] 0 0
United States of America
State/province [26] 0 0
South Carolina
Country [27] 0 0
United States of America
State/province [27] 0 0
Tennessee
Country [28] 0 0
United States of America
State/province [28] 0 0
Texas
Country [29] 0 0
United States of America
State/province [29] 0 0
Utah
Country [30] 0 0
United States of America
State/province [30] 0 0
Virginia
Country [31] 0 0
United States of America
State/province [31] 0 0
West Virginia
Country [32] 0 0
United States of America
State/province [32] 0 0
Wisconsin
Country [33] 0 0
Argentina
State/province [33] 0 0
Buenos Aires
Country [34] 0 0
Argentina
State/province [34] 0 0
Ciudad Auton. De Buenos Aires
Country [35] 0 0
Argentina
State/province [35] 0 0
Santa Fe
Country [36] 0 0
Argentina
State/province [36] 0 0
Córdoba
Country [37] 0 0
Argentina
State/province [37] 0 0
Mendoza
Country [38] 0 0
Argentina
State/province [38] 0 0
Salta
Country [39] 0 0
Austria
State/province [39] 0 0
Niederösterreich
Country [40] 0 0
Austria
State/province [40] 0 0
Oberösterreich
Country [41] 0 0
Austria
State/province [41] 0 0
Salzburg
Country [42] 0 0
Austria
State/province [42] 0 0
Steiermark
Country [43] 0 0
Austria
State/province [43] 0 0
Tirol
Country [44] 0 0
Austria
State/province [44] 0 0
Vorarlberg
Country [45] 0 0
Austria
State/province [45] 0 0
Wien
Country [46] 0 0
Belgium
State/province [46] 0 0
Limburg
Country [47] 0 0
Belgium
State/province [47] 0 0
Liège
Country [48] 0 0
Belgium
State/province [48] 0 0
Brugge
Country [49] 0 0
Belgium
State/province [49] 0 0
Brussel
Country [50] 0 0
Belgium
State/province [50] 0 0
Bruxelles - Brussel
Country [51] 0 0
Belgium
State/province [51] 0 0
Gent
Country [52] 0 0
Belgium
State/province [52] 0 0
Kortrijk
Country [53] 0 0
Belgium
State/province [53] 0 0
Leuven
Country [54] 0 0
Belgium
State/province [54] 0 0
Ostend
Country [55] 0 0
Belgium
State/province [55] 0 0
Sint-Niklaas
Country [56] 0 0
Belgium
State/province [56] 0 0
Uccle
Country [57] 0 0
Brazil
State/province [57] 0 0
Bahia
Country [58] 0 0
Brazil
State/province [58] 0 0
Ceará
Country [59] 0 0
Brazil
State/province [59] 0 0
Distrito Federal
Country [60] 0 0
Brazil
State/province [60] 0 0
Espírito Santo
Country [61] 0 0
Brazil
State/province [61] 0 0
Mato Grosso Do Sul
Country [62] 0 0
Brazil
State/province [62] 0 0
Minas Gerais
Country [63] 0 0
Brazil
State/province [63] 0 0
Parana
Country [64] 0 0
Brazil
State/province [64] 0 0
Rio Grande Do Sul
Country [65] 0 0
Brazil
State/province [65] 0 0
Santa Catarina
Country [66] 0 0
Brazil
State/province [66] 0 0
Sao Paulo
Country [67] 0 0
Brazil
State/province [67] 0 0
Rio de Janeiro
Country [68] 0 0
Bulgaria
State/province [68] 0 0
Dupnitsa
Country [69] 0 0
Bulgaria
State/province [69] 0 0
Haskovo
Country [70] 0 0
Bulgaria
State/province [70] 0 0
Pazardzhik
Country [71] 0 0
Bulgaria
State/province [71] 0 0
Pleven
Country [72] 0 0
Bulgaria
State/province [72] 0 0
Plovdiv
Country [73] 0 0
Bulgaria
State/province [73] 0 0
Ruse
Country [74] 0 0
Bulgaria
State/province [74] 0 0
Sofia
Country [75] 0 0
Bulgaria
State/province [75] 0 0
Varna
Country [76] 0 0
Canada
State/province [76] 0 0
Alberta
Country [77] 0 0
Canada
State/province [77] 0 0
British Columbia
Country [78] 0 0
Canada
State/province [78] 0 0
Manitoba
Country [79] 0 0
Canada
State/province [79] 0 0
Nova Scotia
Country [80] 0 0
Canada
State/province [80] 0 0
Ontario
Country [81] 0 0
Canada
State/province [81] 0 0
Quebec
Country [82] 0 0
Canada
State/province [82] 0 0
Saskatchewan
Country [83] 0 0
Canada
State/province [83] 0 0
Lethbridge
Country [84] 0 0
China
State/province [84] 0 0
Anhui
Country [85] 0 0
China
State/province [85] 0 0
Gansu
Country [86] 0 0
China
State/province [86] 0 0
Guangdong
Country [87] 0 0
China
State/province [87] 0 0
Guangxi
Country [88] 0 0
China
State/province [88] 0 0
Hainan
Country [89] 0 0
China
State/province [89] 0 0
Hebei
Country [90] 0 0
China
State/province [90] 0 0
Heilongjiang
Country [91] 0 0
China
State/province [91] 0 0
Henan
Country [92] 0 0
China
State/province [92] 0 0
Hubei
Country [93] 0 0
China
State/province [93] 0 0
Hunan
Country [94] 0 0
China
State/province [94] 0 0
Inner Mongolia
Country [95] 0 0
China
State/province [95] 0 0
Jiangsu
Country [96] 0 0
China
State/province [96] 0 0
Jiangxi
Country [97] 0 0
China
State/province [97] 0 0
Jilin
Country [98] 0 0
China
State/province [98] 0 0
Liaoning
Country [99] 0 0
China
State/province [99] 0 0
Ningxia
Country [100] 0 0
China
State/province [100] 0 0
Qinghai
Country [101] 0 0
China
State/province [101] 0 0
Shaanxi
Country [102] 0 0
China
State/province [102] 0 0
Shandong
Country [103] 0 0
China
State/province [103] 0 0
Shanxi
Country [104] 0 0
China
State/province [104] 0 0
Sichuan
Country [105] 0 0
China
State/province [105] 0 0
Zhejiang
Country [106] 0 0
China
State/province [106] 0 0
Beijing
Country [107] 0 0
China
State/province [107] 0 0
Shanghai
Country [108] 0 0
China
State/province [108] 0 0
Tianjin
Country [109] 0 0
Colombia
State/province [109] 0 0
Antioquia
Country [110] 0 0
Colombia
State/province [110] 0 0
Atlántico
Country [111] 0 0
Colombia
State/province [111] 0 0
Cundinamarca
Country [112] 0 0
Colombia
State/province [112] 0 0
Quindío
Country [113] 0 0
Colombia
State/province [113] 0 0
Valle Del Cauca
Country [114] 0 0
Colombia
State/province [114] 0 0
Cali
Country [115] 0 0
Colombia
State/province [115] 0 0
Floridablanca
Country [116] 0 0
Colombia
State/province [116] 0 0
Medellin
Country [117] 0 0
Colombia
State/province [117] 0 0
Medellín
Country [118] 0 0
Czechia
State/province [118] 0 0
Brno
Country [119] 0 0
Czechia
State/province [119] 0 0
Ceské Budejovice
Country [120] 0 0
Czechia
State/province [120] 0 0
Chomutov
Country [121] 0 0
Czechia
State/province [121] 0 0
Jihlava
Country [122] 0 0
Czechia
State/province [122] 0 0
Karvina
Country [123] 0 0
Czechia
State/province [123] 0 0
Liberec
Country [124] 0 0
Czechia
State/province [124] 0 0
Ostrava - Poruba
Country [125] 0 0
Czechia
State/province [125] 0 0
Ostrava - Vitkovice
Country [126] 0 0
Czechia
State/province [126] 0 0
Pardubice
Country [127] 0 0
Czechia
State/province [127] 0 0
Praha 4
Country [128] 0 0
Czechia
State/province [128] 0 0
Praha 5-Motol
Country [129] 0 0
Czechia
State/province [129] 0 0
Praha 6
Country [130] 0 0
Czechia
State/province [130] 0 0
Praha
Country [131] 0 0
Czechia
State/province [131] 0 0
Zlín
Country [132] 0 0
Czechia
State/province [132] 0 0
Ústí nad Labem
Country [133] 0 0
Denmark
State/province [133] 0 0
Aalborg
Country [134] 0 0
Denmark
State/province [134] 0 0
Aarhus N
Country [135] 0 0
Denmark
State/province [135] 0 0
Glostrup
Country [136] 0 0
Denmark
State/province [136] 0 0
Herlev
Country [137] 0 0
Denmark
State/province [137] 0 0
Herning
Country [138] 0 0
Denmark
State/province [138] 0 0
Kolding
Country [139] 0 0
Denmark
State/province [139] 0 0
København NV
Country [140] 0 0
Denmark
State/province [140] 0 0
Odense C
Country [141] 0 0
Finland
State/province [141] 0 0
Helsinki
Country [142] 0 0
Finland
State/province [142] 0 0
Joensuu
Country [143] 0 0
Finland
State/province [143] 0 0
Kuopio
Country [144] 0 0
Finland
State/province [144] 0 0
Tampere
Country [145] 0 0
Finland
State/province [145] 0 0
Turku
Country [146] 0 0
France
State/province [146] 0 0
Besancon
Country [147] 0 0
France
State/province [147] 0 0
Bordeaux
Country [148] 0 0
France
State/province [148] 0 0
Boulogne-sur-mer
Country [149] 0 0
France
State/province [149] 0 0
Brest Cedex
Country [150] 0 0
France
State/province [150] 0 0
Corbeil-essonnes
Country [151] 0 0
France
State/province [151] 0 0
DIJON Cedex
Country [152] 0 0
France
State/province [152] 0 0
Garches
Country [153] 0 0
France
State/province [153] 0 0
Le Kremlin-bicetre
Country [154] 0 0
France
State/province [154] 0 0
Le Mans
Country [155] 0 0
France
State/province [155] 0 0
Lille
Country [156] 0 0
France
State/province [156] 0 0
LOMME cedex
Country [157] 0 0
France
State/province [157] 0 0
Lyon
Country [158] 0 0
France
State/province [158] 0 0
Marseille
Country [159] 0 0
France
State/province [159] 0 0
Nancy
Country [160] 0 0
France
State/province [160] 0 0
Nantes
Country [161] 0 0
France
State/province [161] 0 0
Nice
Country [162] 0 0
France
State/province [162] 0 0
Nîmes
Country [163] 0 0
France
State/province [163] 0 0
Paris
Country [164] 0 0
France
State/province [164] 0 0
Reims
Country [165] 0 0
France
State/province [165] 0 0
Rennes Cedex
Country [166] 0 0
France
State/province [166] 0 0
Strasbourg
Country [167] 0 0
France
State/province [167] 0 0
SURESNES Cedex
Country [168] 0 0
France
State/province [168] 0 0
Toulon cedex 09
Country [169] 0 0
France
State/province [169] 0 0
Toulouse
Country [170] 0 0
France
State/province [170] 0 0
TOURS cedex 9
Country [171] 0 0
Germany
State/province [171] 0 0
Baden-Württemberg
Country [172] 0 0
Germany
State/province [172] 0 0
Bayern
Country [173] 0 0
Germany
State/province [173] 0 0
Hessen
Country [174] 0 0
Germany
State/province [174] 0 0
Mecklenburg-Vorpommern
Country [175] 0 0
Germany
State/province [175] 0 0
Niedersachsen
Country [176] 0 0
Germany
State/province [176] 0 0
Nordrhein-Westfalen
Country [177] 0 0
Germany
State/province [177] 0 0
Rheinland-Pfalz
Country [178] 0 0
Germany
State/province [178] 0 0
Sachsen-Anhalt
Country [179] 0 0
Germany
State/province [179] 0 0
Sachsen
Country [180] 0 0
Germany
State/province [180] 0 0
Thüringen
Country [181] 0 0
Germany
State/province [181] 0 0
Berlin
Country [182] 0 0
Germany
State/province [182] 0 0
Hamburg
Country [183] 0 0
Greece
State/province [183] 0 0
Alexandroupoli
Country [184] 0 0
Greece
State/province [184] 0 0
Athens
Country [185] 0 0
Greece
State/province [185] 0 0
Chaidari
Country [186] 0 0
Greece
State/province [186] 0 0
Heraklion
Country [187] 0 0
Greece
State/province [187] 0 0
Ioannina
Country [188] 0 0
Greece
State/province [188] 0 0
Larissa
Country [189] 0 0
Greece
State/province [189] 0 0
Neo Faliro Piraeus
Country [190] 0 0
Greece
State/province [190] 0 0
Patra
Country [191] 0 0
Greece
State/province [191] 0 0
Pilea Chortiatis Thessaloniki
Country [192] 0 0
Greece
State/province [192] 0 0
Thessaloniki
Country [193] 0 0
Hungary
State/province [193] 0 0
Baja
Country [194] 0 0
Hungary
State/province [194] 0 0
Budapest
Country [195] 0 0
Hungary
State/province [195] 0 0
Debrecen
Country [196] 0 0
Hungary
State/province [196] 0 0
Gyor
Country [197] 0 0
Hungary
State/province [197] 0 0
Kistarcsa
Country [198] 0 0
Hungary
State/province [198] 0 0
Kisvarda
Country [199] 0 0
Hungary
State/province [199] 0 0
Nagykanizsa
Country [200] 0 0
Hungary
State/province [200] 0 0
Nyiregyhaza
Country [201] 0 0
Hungary
State/province [201] 0 0
Pecs
Country [202] 0 0
Hungary
State/province [202] 0 0
Sopron
Country [203] 0 0
Hungary
State/province [203] 0 0
Szeged
Country [204] 0 0
Hungary
State/province [204] 0 0
Zalaegerszeg
Country [205] 0 0
India
State/province [205] 0 0
Ahmedabad
Country [206] 0 0
India
State/province [206] 0 0
Bangalore
Country [207] 0 0
India
State/province [207] 0 0
Chandigarh
Country [208] 0 0
India
State/province [208] 0 0
Coimbatore
Country [209] 0 0
India
State/province [209] 0 0
Guntur
Country [210] 0 0
India
State/province [210] 0 0
Gurgaon
Country [211] 0 0
India
State/province [211] 0 0
Guwahati
Country [212] 0 0
India
State/province [212] 0 0
Hyderabad
Country [213] 0 0
India
State/province [213] 0 0
Jaipur
Country [214] 0 0
India
State/province [214] 0 0
Karamsad
Country [215] 0 0
India
State/province [215] 0 0
Kolkata
Country [216] 0 0
India
State/province [216] 0 0
Kozhikode
Country [217] 0 0
India
State/province [217] 0 0
Ludhiana
Country [218] 0 0
India
State/province [218] 0 0
Nagpur
Country [219] 0 0
India
State/province [219] 0 0
New Delhi
Country [220] 0 0
India
State/province [220] 0 0
Pune
Country [221] 0 0
India
State/province [221] 0 0
Thiruvananthapuram
Country [222] 0 0
India
State/province [222] 0 0
Vellore
Country [223] 0 0
Israel
State/province [223] 0 0
Ashdod
Country [224] 0 0
Israel
State/province [224] 0 0
Ashkelon
Country [225] 0 0
Israel
State/province [225] 0 0
Beer Sheva
Country [226] 0 0
Israel
State/province [226] 0 0
Hadera
Country [227] 0 0
Israel
State/province [227] 0 0
Haifa
Country [228] 0 0
Israel
State/province [228] 0 0
Holon
Country [229] 0 0
Israel
State/province [229] 0 0
Jerusalem
Country [230] 0 0
Israel
State/province [230] 0 0
Kfar Saba
Country [231] 0 0
Israel
State/province [231] 0 0
Petach Tikva
Country [232] 0 0
Israel
State/province [232] 0 0
Tel Aviv
Country [233] 0 0
Israel
State/province [233] 0 0
Tel Hashomer
Country [234] 0 0
Israel
State/province [234] 0 0
Zefat
Country [235] 0 0
Israel
State/province [235] 0 0
Zerifin
Country [236] 0 0
Italy
State/province [236] 0 0
Abruzzo
Country [237] 0 0
Italy
State/province [237] 0 0
Campania
Country [238] 0 0
Italy
State/province [238] 0 0
Emilia-Romagna
Country [239] 0 0
Italy
State/province [239] 0 0
Friuli-Venezia Giulia
Country [240] 0 0
Italy
State/province [240] 0 0
Lazio
Country [241] 0 0
Italy
State/province [241] 0 0
Liguria
Country [242] 0 0
Italy
State/province [242] 0 0
Lombardia
Country [243] 0 0
Italy
State/province [243] 0 0
Puglia
Country [244] 0 0
Italy
State/province [244] 0 0
Sicilia
Country [245] 0 0
Italy
State/province [245] 0 0
Toscana
Country [246] 0 0
Italy
State/province [246] 0 0
Umbria
Country [247] 0 0
Italy
State/province [247] 0 0
Veneto
Country [248] 0 0
Italy
State/province [248] 0 0
Ancona
Country [249] 0 0
Japan
State/province [249] 0 0
Aichi
Country [250] 0 0
Japan
State/province [250] 0 0
Chiba
Country [251] 0 0
Japan
State/province [251] 0 0
Fukuoka
Country [252] 0 0
Japan
State/province [252] 0 0
Fukushima
Country [253] 0 0
Japan
State/province [253] 0 0
Gifu
Country [254] 0 0
Japan
State/province [254] 0 0
Gunma
Country [255] 0 0
Japan
State/province [255] 0 0
Hiroshima
Country [256] 0 0
Japan
State/province [256] 0 0
Hokkaido
Country [257] 0 0
Japan
State/province [257] 0 0
Hyogo
Country [258] 0 0
Japan
State/province [258] 0 0
Ibaraki
Country [259] 0 0
Japan
State/province [259] 0 0
Kagawa
Country [260] 0 0
Japan
State/province [260] 0 0
Kanagawa
Country [261] 0 0
Japan
State/province [261] 0 0
Miyagi
Country [262] 0 0
Japan
State/province [262] 0 0
Nagano
Country [263] 0 0
Japan
State/province [263] 0 0
Oita
Country [264] 0 0
Japan
State/province [264] 0 0
Osaka
Country [265] 0 0
Japan
State/province [265] 0 0
Saga
Country [266] 0 0
Japan
State/province [266] 0 0
Saitama
Country [267] 0 0
Japan
State/province [267] 0 0
Shizuoka
Country [268] 0 0
Japan
State/province [268] 0 0
Tokyo
Country [269] 0 0
Japan
State/province [269] 0 0
Wakayama
Country [270] 0 0
Japan
State/province [270] 0 0
Yamaguchi
Country [271] 0 0
Japan
State/province [271] 0 0
Yamanashi
Country [272] 0 0
Japan
State/province [272] 0 0
Kagoshima
Country [273] 0 0
Japan
State/province [273] 0 0
Kochi
Country [274] 0 0
Japan
State/province [274] 0 0
Kumamoto
Country [275] 0 0
Japan
State/province [275] 0 0
Kyoto
Country [276] 0 0
Japan
State/province [276] 0 0
Okayama
Country [277] 0 0
Kazakhstan
State/province [277] 0 0
Aktobe
Country [278] 0 0
Kazakhstan
State/province [278] 0 0
Almaty
Country [279] 0 0
Kazakhstan
State/province [279] 0 0
Astana
Country [280] 0 0
Kazakhstan
State/province [280] 0 0
Shymkent
Country [281] 0 0
Korea, Republic of
State/province [281] 0 0
Chungcheongbugdo
Country [282] 0 0
Korea, Republic of
State/province [282] 0 0
Daegu Gwang''yeogsi
Country [283] 0 0
Korea, Republic of
State/province [283] 0 0
Gyeonggido
Country [284] 0 0
Korea, Republic of
State/province [284] 0 0
Seoul Teugbyeolsi
Country [285] 0 0
Korea, Republic of
State/province [285] 0 0
Busan
Country [286] 0 0
Korea, Republic of
State/province [286] 0 0
Daegu
Country [287] 0 0
Korea, Republic of
State/province [287] 0 0
Daejeon
Country [288] 0 0
Korea, Republic of
State/province [288] 0 0
Gwangju
Country [289] 0 0
Korea, Republic of
State/province [289] 0 0
Incheon
Country [290] 0 0
Korea, Republic of
State/province [290] 0 0
Seoul,
Country [291] 0 0
Korea, Republic of
State/province [291] 0 0
Seoul
Country [292] 0 0
Latvia
State/province [292] 0 0
Jekabpils
Country [293] 0 0
Latvia
State/province [293] 0 0
Rezekne
Country [294] 0 0
Latvia
State/province [294] 0 0
Riga
Country [295] 0 0
Latvia
State/province [295] 0 0
Valmiera
Country [296] 0 0
Lithuania
State/province [296] 0 0
Alytus
Country [297] 0 0
Lithuania
State/province [297] 0 0
Kaunas
Country [298] 0 0
Lithuania
State/province [298] 0 0
Siauliai
Country [299] 0 0
Lithuania
State/province [299] 0 0
Vilnius
Country [300] 0 0
Malaysia
State/province [300] 0 0
Kelantan
Country [301] 0 0
Malaysia
State/province [301] 0 0
Kota Kinabalu
Country [302] 0 0
Malaysia
State/province [302] 0 0
Kuala Lumpur
Country [303] 0 0
Malaysia
State/province [303] 0 0
Pulau Pinang
Country [304] 0 0
Malaysia
State/province [304] 0 0
Sarawak
Country [305] 0 0
Malaysia
State/province [305] 0 0
Selangor
Country [306] 0 0
Malaysia
State/province [306] 0 0
Terengganu
Country [307] 0 0
Netherlands
State/province [307] 0 0
Noord-Brabant
Country [308] 0 0
Netherlands
State/province [308] 0 0
Amsterdam
Country [309] 0 0
Netherlands
State/province [309] 0 0
Den Bosch
Country [310] 0 0
Netherlands
State/province [310] 0 0
Den Haag
Country [311] 0 0
Netherlands
State/province [311] 0 0
Enschede
Country [312] 0 0
Netherlands
State/province [312] 0 0
Heerlen
Country [313] 0 0
Netherlands
State/province [313] 0 0
Nieuwegein
Country [314] 0 0
Netherlands
State/province [314] 0 0
Rotterdam
Country [315] 0 0
Netherlands
State/province [315] 0 0
Utrecht
Country [316] 0 0
Netherlands
State/province [316] 0 0
Zwolle
Country [317] 0 0
Norway
State/province [317] 0 0
Bergen
Country [318] 0 0
Norway
State/province [318] 0 0
Fredrikstad
Country [319] 0 0
Norway
State/province [319] 0 0
Kristiansand
Country [320] 0 0
Norway
State/province [320] 0 0
Lørenskog
Country [321] 0 0
Norway
State/province [321] 0 0
Molde
Country [322] 0 0
Norway
State/province [322] 0 0
Oslo
Country [323] 0 0
Norway
State/province [323] 0 0
Trondheim
Country [324] 0 0
Norway
State/province [324] 0 0
Ålesund
Country [325] 0 0
Poland
State/province [325] 0 0
Bialystok
Country [326] 0 0
Poland
State/province [326] 0 0
Bydgoszcz
Country [327] 0 0
Poland
State/province [327] 0 0
Gdansk
Country [328] 0 0
Poland
State/province [328] 0 0
Grodzisk Mazowiecki
Country [329] 0 0
Poland
State/province [329] 0 0
Katowice
Country [330] 0 0
Poland
State/province [330] 0 0
Krakow
Country [331] 0 0
Poland
State/province [331] 0 0
Lodz
Country [332] 0 0
Poland
State/province [332] 0 0
Lublin
Country [333] 0 0
Poland
State/province [333] 0 0
Opole
Country [334] 0 0
Poland
State/province [334] 0 0
Szczecin
Country [335] 0 0
Poland
State/province [335] 0 0
Warszawa
Country [336] 0 0
Portugal
State/province [336] 0 0
Lisboa
Country [337] 0 0
Portugal
State/province [337] 0 0
Porto
Country [338] 0 0
Portugal
State/province [338] 0 0
Setúbal
Country [339] 0 0
Portugal
State/province [339] 0 0
Aveiro
Country [340] 0 0
Portugal
State/province [340] 0 0
Coimbra
Country [341] 0 0
Portugal
State/province [341] 0 0
Faro
Country [342] 0 0
Romania
State/province [342] 0 0
Brasov
Country [343] 0 0
Romania
State/province [343] 0 0
Bucharest
Country [344] 0 0
Romania
State/province [344] 0 0
Bucuresti
Country [345] 0 0
Romania
State/province [345] 0 0
Iasi
Country [346] 0 0
Romania
State/province [346] 0 0
Oradea
Country [347] 0 0
Romania
State/province [347] 0 0
Sibiu
Country [348] 0 0
Romania
State/province [348] 0 0
Suceava
Country [349] 0 0
Romania
State/province [349] 0 0
Targu Mures
Country [350] 0 0
Romania
State/province [350] 0 0
Timisoara
Country [351] 0 0
Slovakia
State/province [351] 0 0
Bratislava
Country [352] 0 0
Slovakia
State/province [352] 0 0
Dolny Kubin
Country [353] 0 0
Slovakia
State/province [353] 0 0
Komarno
Country [354] 0 0
Slovakia
State/province [354] 0 0
Levoca
Country [355] 0 0
Slovakia
State/province [355] 0 0
Liptovsky Mikulas
Country [356] 0 0
Slovakia
State/province [356] 0 0
Lucenec
Country [357] 0 0
Slovakia
State/province [357] 0 0
Martin
Country [358] 0 0
Slovakia
State/province [358] 0 0
Nitra
Country [359] 0 0
Slovakia
State/province [359] 0 0
Presov
Country [360] 0 0
Slovakia
State/province [360] 0 0
Rimavska Sobota
Country [361] 0 0
Slovakia
State/province [361] 0 0
Skalica
Country [362] 0 0
Slovakia
State/province [362] 0 0
Spisska Nova Ves
Country [363] 0 0
Slovakia
State/province [363] 0 0
Trnava
Country [364] 0 0
Slovakia
State/province [364] 0 0
Vranov nad Toplou
Country [365] 0 0
Slovakia
State/province [365] 0 0
Ziar nad Hronom
Country [366] 0 0
Spain
State/province [366] 0 0
A Coruña
Country [367] 0 0
Spain
State/province [367] 0 0
Barcelona
Country [368] 0 0
Spain
State/province [368] 0 0
Madrid
Country [369] 0 0
Spain
State/province [369] 0 0
Pontevedra
Country [370] 0 0
Spain
State/province [370] 0 0
Vizcaya
Country [371] 0 0
Spain
State/province [371] 0 0
Albacete
Country [372] 0 0
Spain
State/province [372] 0 0
Girona
Country [373] 0 0
Spain
State/province [373] 0 0
León
Country [374] 0 0
Spain
State/province [374] 0 0
Lleida
Country [375] 0 0
Spain
State/province [375] 0 0
Murcia
Country [376] 0 0
Spain
State/province [376] 0 0
Sevilla
Country [377] 0 0
Spain
State/province [377] 0 0
Tarragona
Country [378] 0 0
Spain
State/province [378] 0 0
Valencia
Country [379] 0 0
Spain
State/province [379] 0 0
Valladolid
Country [380] 0 0
Spain
State/province [380] 0 0
Zaragoza
Country [381] 0 0
Sweden
State/province [381] 0 0
Danderyd
Country [382] 0 0
Sweden
State/province [382] 0 0
Göteborg
Country [383] 0 0
Sweden
State/province [383] 0 0
Hässleholm
Country [384] 0 0
Sweden
State/province [384] 0 0
Lund
Country [385] 0 0
Sweden
State/province [385] 0 0
Stockholm
Country [386] 0 0
Sweden
State/province [386] 0 0
Uppsala
Country [387] 0 0
Sweden
State/province [387] 0 0
Östersund
Country [388] 0 0
Switzerland
State/province [388] 0 0
Basel-Stadt
Country [389] 0 0
Switzerland
State/province [389] 0 0
Genève
Country [390] 0 0
Switzerland
State/province [390] 0 0
Sankt Gallen
Country [391] 0 0
Switzerland
State/province [391] 0 0
Ticino
Country [392] 0 0
Switzerland
State/province [392] 0 0
Vaud
Country [393] 0 0
Switzerland
State/province [393] 0 0
Baden
Country [394] 0 0
Switzerland
State/province [394] 0 0
Bern
Country [395] 0 0
Switzerland
State/province [395] 0 0
Villars sur Glâne
Country [396] 0 0
Switzerland
State/province [396] 0 0
Zürich
Country [397] 0 0
Taiwan
State/province [397] 0 0
Hsinchu
Country [398] 0 0
Taiwan
State/province [398] 0 0
Kaohsiung
Country [399] 0 0
Taiwan
State/province [399] 0 0
Taipei
Country [400] 0 0
Taiwan
State/province [400] 0 0
Changhua
Country [401] 0 0
Taiwan
State/province [401] 0 0
Kaohsiung City
Country [402] 0 0
Taiwan
State/province [402] 0 0
Keelung
Country [403] 0 0
Taiwan
State/province [403] 0 0
New Taipei City
Country [404] 0 0
Taiwan
State/province [404] 0 0
Taichung
Country [405] 0 0
Taiwan
State/province [405] 0 0
Tainan
Country [406] 0 0
Taiwan
State/province [406] 0 0
Taizung
Country [407] 0 0
Taiwan
State/province [407] 0 0
Taoyuan
Country [408] 0 0
Turkey
State/province [408] 0 0
Ankara
Country [409] 0 0
Turkey
State/province [409] 0 0
Antalya
Country [410] 0 0
Turkey
State/province [410] 0 0
Elazig
Country [411] 0 0
Turkey
State/province [411] 0 0
Eskisehir
Country [412] 0 0
Turkey
State/province [412] 0 0
Istanbul
Country [413] 0 0
Turkey
State/province [413] 0 0
Izmir
Country [414] 0 0
Turkey
State/province [414] 0 0
Konya
Country [415] 0 0
Turkey
State/province [415] 0 0
Samsun
Country [416] 0 0
Turkey
State/province [416] 0 0
Sivas
Country [417] 0 0
United Kingdom
State/province [417] 0 0
Hampshire
Country [418] 0 0
United Kingdom
State/province [418] 0 0
Kent
Country [419] 0 0
United Kingdom
State/province [419] 0 0
London
Country [420] 0 0
United Kingdom
State/province [420] 0 0
Manchester
Country [421] 0 0
United Kingdom
State/province [421] 0 0
Staffordshire
Country [422] 0 0
United Kingdom
State/province [422] 0 0
Tyne And Wear
Country [423] 0 0
United Kingdom
State/province [423] 0 0
West Yorkshire
Country [424] 0 0
United Kingdom
State/province [424] 0 0
Derby
Country [425] 0 0
United Kingdom
State/province [425] 0 0
Edinburgh
Country [426] 0 0
United Kingdom
State/province [426] 0 0
Exeter
Country [427] 0 0
United Kingdom
State/province [427] 0 0
Glasgow
Country [428] 0 0
United Kingdom
State/province [428] 0 0
Liverpool
Country [429] 0 0
United Kingdom
State/province [429] 0 0
Oxford

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Bayer
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Researchers are looking for a better way to prevent an ischemic stroke which occurs when a
blood clot travelled to the brain in people who within the last 72 hours had:

- an acute stroke due to a blood clot that formed outside the heart (acute
non-cardioembolic ischemic stroke), or

- TIA/mini-stroke with a high risk of turning into a stroke (high-risk transient ischemic
attack), and who are planned to receive standard of care therapy. Acute ischemic strokes
or TIA/mini-stroke result from a blocked or reduced blood flow to a part of the brain.
They are caused by blood clots that travel to the brain and block the vessels that
supply it. If these blood clots form elsewhere than in the heart, the stroke is called
non-cardioembolic. People who already had a non-cardioembolic stroke are more likely to
have another stroke. This is why they are treated preventively with an antiplatelet
therapy, the current standard of care. Antiplatelet medicines prevent platelets,
components of blood clotting, from clumping together.

Anticoagulants are another type of medicine that prevents blood clots from forming by
interfering with a process known as coagulation (or blood clotting).

The study treatment asundexian is a new type of anticoagulant currently under development to
provide further treatment options. Asundexian aims to further improve the standard of care
without increasing the risk of bleeding.

The main purpose of this study is to learn whether asundexian works better than placebo at
reducing ischemic strokes in participants who recently had a non-cardioembolic ischemic
stroke or TIA/mini-stroke when given in addition to standard antiplatelet therapy. A placebo
is a treatment that looks like a medicine but does not have any medicine in it.

Another aim is to compare the occurrence of major bleeding events during the study between
the asundexian and the placebo group. Major bleedings have a serious or even life-threatening
impact on a person's health.

Dependent on the treatment group, the participants will either take asundexian or placebo as
tablets once a day for at least 3 months up to 31 months.

Approximately every 3 months during the treatment period, either a phone call or a visit to
the study site is scheduled on an alternating basis. In addition, one visit before and up to
two visits after the treatment period are planned.

During the study, the study team will:

- Check vital signs such as blood pressure and heart rate

- Examine the participants' heart health using an electrocardiogram (ECG)

- Take blood samples

- Ask the participants questions about how they are feeling and what adverse events they
are having.

An adverse event is any medical problem that a participant has during a study. Doctors keep
track of all adverse events that happen in studies, even if they do not think the adverse
events might be related to the study treatments. In addition, the participants will be asked
to complete a questionnaire on quality of life at certain time points during the study.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05686070
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Bayer Clinical Trials Contact
Address 0 0
Country 0 0
Phone 0 0
(+)1-888-84 22937
Fax 0 0
Email 0 0
clinical-trials-contact@bayer.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05686070