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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05643573




Registration number
NCT05643573
Ethics application status
Date submitted
30/11/2022
Date registered
8/12/2022
Date last updated
19/08/2024

Titles & IDs
Public title
A Study to Learn How Well the Study Treatment Asundexian Works and How Safe it is Compared to Apixaban to Prevent Stroke or Systemic Embolism in People With Irregular and Often Rapid Heartbeat (Atrial Fibrillation), and at Risk for Stroke
Scientific title
A Multicenter, International, Randomized, Active Comparator-controlled, Double-blind, Double-dummy, Parallel-group, 2-arm, Phase 3 Study to Compare the Efficacy and Safety of the Oral FXIa Inhibitor Asundexian (BAY 2433334) With Apixaban for the Prevention of Stroke or Systemic Embolism in Male and Female Participants Aged 18 Years and Older With Atrial Fibrillation at Risk for Stroke
Secondary ID [1] 0 0
2023-503794-38-00
Secondary ID [2] 0 0
19767
Universal Trial Number (UTN)
Trial acronym
OCEANIC-AF
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prevention of Stroke or Systemic Embolism 0 0
Atrial Fibrillation 0 0
Condition category
Condition code
Stroke 0 0 0 0
Haemorrhagic
Stroke 0 0 0 0
Ischaemic
Cardiovascular 0 0 0 0
Other cardiovascular diseases
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Blood 0 0 0 0
Clotting disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Asundexian (BAY2433334)
Treatment: Drugs - Apixaban
Treatment: Drugs - Asundexian matching placebo
Treatment: Drugs - Apixaban matching placebo

Experimental: Asundexian - Participants will receive asundexian and apixaban matching placebo.

Active comparator: Apixaban - Participants will receive apixaban and asundexian matching placebo.


Treatment: Drugs: Asundexian (BAY2433334)
Once a day

Treatment: Drugs: Apixaban
5 mg or 2.5 mg, twice a day, according to product label.

Treatment: Drugs: Asundexian matching placebo
Placebo to asundexian, once a day

Treatment: Drugs: Apixaban matching placebo
Placebo to apixaban, twice a day
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Time to first occurrence of composite of stroke or systemic embolism
Timepoint [1] 0 0
Up to 34 months
Primary outcome [2] 0 0
Time to first occurrence of ISTH major bleeding
Timepoint [2] 0 0
Up to 34 months
Primary outcome [3] 0 0
Time to first occurrence of composite of stroke, systemic embolism, or ISTH major bleeding
Timepoint [3] 0 0
Up to 34 months
Secondary outcome [1] 0 0
Time to first occurrence of composite of ischemic stroke or systemic embolism
Timepoint [1] 0 0
Up to 34 months
Secondary outcome [2] 0 0
Time to first occurrence of all-cause mortality
Timepoint [2] 0 0
Up to 34 months
Secondary outcome [3] 0 0
Time to first occurrence of ischemic stroke
Timepoint [3] 0 0
Up to 34 months
Secondary outcome [4] 0 0
Time to first occurrence of CV death
Timepoint [4] 0 0
Up to 34 months
Secondary outcome [5] 0 0
Time to first occurrence of composite of CV death, stroke, or myocardial infarction
Timepoint [5] 0 0
Up to 34 months
Secondary outcome [6] 0 0
Time to first occurrence of composite of ISTH major or clinically relevant non-major bleeding
Timepoint [6] 0 0
Up to 34 months
Secondary outcome [7] 0 0
Time to first occurrence of clinically relevant non-major bleeding
Timepoint [7] 0 0
Up to 34 months
Secondary outcome [8] 0 0
Time to first occurrence of hemorrhagic stroke
Timepoint [8] 0 0
Up to 34 months
Secondary outcome [9] 0 0
Time to first occurrence of intracranial hemorrhage
Timepoint [9] 0 0
Up to 34 months
Secondary outcome [10] 0 0
Time to first occurrence of fatal bleeding
Timepoint [10] 0 0
Up to 34 months
Secondary outcome [11] 0 0
Time to first occurrence of minor bleeding
Timepoint [11] 0 0
Up to 34 months
Secondary outcome [12] 0 0
Time to first occurrence of composite of stroke, systemic embolism, ISTH major bleeding, or all-cause mortality
Timepoint [12] 0 0
Up to 34 months
Secondary outcome [13] 0 0
Time to first occurrence of composite of disabling stroke (mRS = 3), critical bleeding, or all-cause mortality
Timepoint [13] 0 0
Up to 34 months

Eligibility
Key inclusion criteria
* 18 years of age or older
* The patient willing and able to understand the Patient information Sheet and provide written informed consent
* Atrial fibrillation with an indication for indefinite treatment with an oral anticoagulant
* CHA2DS2-VASc score = 3 if male or = 4 if female, OR CHA2DS2-VASc score of 2 if male or 3 if female and at least one of the following enrichment criteria:

* age = 70
* previous stroke, transient ischemic attack, or systemic embolism
* renal dysfunction with eGFR < 50 ml/min within 14 days prior to randomization
* prior episode of non-traumatic major bleeding
* current single agent antiplatelet therapy planned to continue for at least 6 months after randomization
* = 6 consecutive weeks of treatment with oral anticoagulant prior to randomization.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Mechanical heart valve prosthesis
* Moderate-to-severe mitral stenosis at the time of study inclusion.
* Atrial fibrillation only due to reversible cause.
* Participants after successful ablation therapy without documented recurrent AF or participants after left atrial appendage occlusion / exclusion or plan for ablation or Left atrial appendage (LAA) occlusion / exclusion within the next 6 months.
* Recent ischemic stroke (within 7 days prior to randomization).
* Active non-trivial bleeding; known chronic bleeding disorder ; history of non-traumatic intracranial hemorrhage.
* Known significant liver disease or known hepatic insufficiency classified as Child-Pugh B or C at randomization.
* Estimated glomerular filtration rate (eGFR) < 25 mL/min/1.73 m2 within 14 days prior to randomization or on dialysis or expected to be started on dialysis within the next 12 months starting from randomization.
* Major surgery during the last 30 days prior to randomization.
* Known allergy, intolerance or hypersensitivity to either of the study interventions.
* Any contraindication for the use of an anticoagulant or listed in the local labelling for apixaban.
* Requirement for chronic anticoagulation for a different indication than AF, e.g. mechanical heart valve or left ventricular cardiac thrombus (atrial thrombus is allowed), or dual antiplatelet therapy (single agent therapy is allowed).
* Treatment with Vitamin K antagonist (VKA) in the 10 days prior to randomization.
* Concomitant use of or anticipated need for:

* daily or near daily (> 5 days per week) therapy with nonsteroidal anti-inflammatory drugs (NSAIDs) for more than 4 weeks during the study
* herbal or traditional medicine, and / or supplements with known anticoagulant and / or antiplatelet effect
* combined P-glycoprotein (P-gp) and strong cytochrome P450 isoenzyme 3A4 (CYP3A4) inhibitors
* combined P-gp and strong / moderate CYP3A4 inducers Respective substances (apart from NSAIDs) must be stopped - in case of combined inhibitors / inducers of CYP3A4 and P-gp for at least 14 days before randomization.
* Previous (within 30 days or 5 half-lives of the investigational drug, whichever is longer) or concomitant participation in another clinical study with investigational medicinal product(s) or device(s). Registries and observational studies are allowed.
* Known current alcohol and / or illicit drug abuse.
* Close affiliation with the investigational site.
* Any other history, condition or therapy, or uncontrolled intercurrent illness which would make the participant unsuitable for the study vulnerable or life expectancy < 12 months.

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
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
5/12/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
31/01/2024
Sample size
Target
Accrual to date
Final
14830
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
The Canberra Hospital - Garran
Recruitment hospital [2] 0 0
Blacktown Hospital - Blacktownn
Recruitment hospital [3] 0 0
Concord Repatriation General Hospital - Concord
Recruitment hospital [4] 0 0
South Western Sydney Local Health District | Liverpool Hospital - Stroke and Neurovascular Department - Liverpool
Recruitment hospital [5] 0 0
John Hunter Hospital - New Lambton
Recruitment hospital [6] 0 0
Illawarra Shoalhaven Local Health District - Wollongong
Recruitment hospital [7] 0 0
Advara HealthCare Wesley - Auchenflower
Recruitment hospital [8] 0 0
Sunshine Coast University Hospital - Birtinya
Recruitment hospital [9] 0 0
Royal Brisbane & Women's Hospital - Brisbane
Recruitment hospital [10] 0 0
The Prince Charles Hospital - Herston
Recruitment hospital [11] 0 0
Redcliffe District Hospital - Redcliffe
Recruitment hospital [12] 0 0
Gold Coast University Hospital - Southport
Recruitment hospital [13] 0 0
Core Research Group Pty Ltd. | Brisbane, Australia - Taringa QLD
Recruitment hospital [14] 0 0
Nightingale Research - Adelaide
Recruitment hospital [15] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [16] 0 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [17] 0 0
Advara HealthCare Leabrook - Leabrook
Recruitment hospital [18] 0 0
Queen Elizabeth Hospital AUS - Woodville South
Recruitment hospital [19] 0 0
Grampians Health Ballarat - Ballarat
Recruitment hospital [20] 0 0
Eastern Health - Box Hill
Recruitment hospital [21] 0 0
Barwon Health - Geelong
Recruitment hospital [22] 0 0
Baker Heart and Diabetes Institute - Hoppers Crossing
Recruitment hospital [23] 0 0
Cabrini Malvern - Malvern
Recruitment hospital [24] 0 0
The Alfred Hospital - Melbourne
Recruitment hospital [25] 0 0
Royal Melbourne Hospital - Parkville
Recruitment hospital [26] 0 0
Advara HeartCare Melbourne - Ringwood
Recruitment hospital [27] 0 0
The Avenue Cardiovascular Centre - St Kilda East
Recruitment hospital [28] 0 0
Fiona Stanley Hospital - Murdoch
Recruitment hospital [29] 0 0
Advara HealthCare Joondalup - Perth
Recruitment hospital [30] 0 0
Nepean Hospital - Kingswood
Recruitment postcode(s) [1] 0 0
2605 - Garran
Recruitment postcode(s) [2] 0 0
2148 - Blacktownn
Recruitment postcode(s) [3] 0 0
2139 - Concord
Recruitment postcode(s) [4] 0 0
2170 - Liverpool
Recruitment postcode(s) [5] 0 0
2305 - New Lambton
Recruitment postcode(s) [6] 0 0
2500 - Wollongong
Recruitment postcode(s) [7] 0 0
4066 - Auchenflower
Recruitment postcode(s) [8] 0 0
4575 - Birtinya
Recruitment postcode(s) [9] 0 0
4029 - Brisbane
Recruitment postcode(s) [10] 0 0
4029 - Herston
Recruitment postcode(s) [11] 0 0
4020 - Redcliffe
Recruitment postcode(s) [12] 0 0
4215 - Southport
Recruitment postcode(s) [13] 0 0
4068 - Taringa QLD
Recruitment postcode(s) [14] 0 0
5000 - Adelaide
Recruitment postcode(s) [15] 0 0
5042 - Bedford Park
Recruitment postcode(s) [16] 0 0
5068 - Leabrook
Recruitment postcode(s) [17] 0 0
5011 - Woodville South
Recruitment postcode(s) [18] 0 0
3350 - Ballarat
Recruitment postcode(s) [19] 0 0
3128 - Box Hill
Recruitment postcode(s) [20] 0 0
3220 - Geelong
Recruitment postcode(s) [21] 0 0
3029 - Hoppers Crossing
Recruitment postcode(s) [22] 0 0
3144 - Malvern
Recruitment postcode(s) [23] 0 0
3004 - Melbourne
Recruitment postcode(s) [24] 0 0
3050 - Parkville
Recruitment postcode(s) [25] 0 0
3135 - Ringwood
Recruitment postcode(s) [26] 0 0
3183 - St Kilda East
Recruitment postcode(s) [27] 0 0
6961 - Murdoch
Recruitment postcode(s) [28] 0 0
6150 - Perth
Recruitment postcode(s) [29] 0 0
2747 - Kingswood
Recruitment outside Australia
Country [1] 0 0
United States of America
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Alabama
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Arkansas
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California
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United States of America
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Colorado
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Connecticut
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Florida
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Georgia
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Illinois
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Indiana
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Iowa
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Kansas
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Kentucky
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Louisiana
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Maine
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Maryland
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Michigan
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Denmark
State/province [153] 0 0
Kolding
Country [154] 0 0
Denmark
State/province [154] 0 0
Roskilde
Country [155] 0 0
Denmark
State/province [155] 0 0
Svendborg
Country [156] 0 0
Denmark
State/province [156] 0 0
Viborg
Country [157] 0 0
Denmark
State/province [157] 0 0
Århus N
Country [158] 0 0
Estonia
State/province [158] 0 0
Rapla
Country [159] 0 0
Estonia
State/province [159] 0 0
Tallinn
Country [160] 0 0
Estonia
State/province [160] 0 0
Tartu
Country [161] 0 0
Finland
State/province [161] 0 0
Espoo
Country [162] 0 0
Finland
State/province [162] 0 0
Jyvaskyla
Country [163] 0 0
Finland
State/province [163] 0 0
Kokkola
Country [164] 0 0
Finland
State/province [164] 0 0
Kuopio
Country [165] 0 0
Finland
State/province [165] 0 0
Lahti
Country [166] 0 0
Finland
State/province [166] 0 0
Oulu
Country [167] 0 0
Finland
State/province [167] 0 0
Tampere
Country [168] 0 0
Finland
State/province [168] 0 0
Turku
Country [169] 0 0
France
State/province [169] 0 0
Angers
Country [170] 0 0
France
State/province [170] 0 0
Bayonne
Country [171] 0 0
France
State/province [171] 0 0
Bois-Guillaume
Country [172] 0 0
France
State/province [172] 0 0
Brest
Country [173] 0 0
France
State/province [173] 0 0
Bron Cedex
Country [174] 0 0
France
State/province [174] 0 0
CAEN cedex 9
Country [175] 0 0
France
State/province [175] 0 0
Chambray-lès-Tours
Country [176] 0 0
France
State/province [176] 0 0
Cholet
Country [177] 0 0
France
State/province [177] 0 0
Creteil
Country [178] 0 0
France
State/province [178] 0 0
GRENOBLE Cedex 09
Country [179] 0 0
France
State/province [179] 0 0
LA ROCHE SUR YON cedex
Country [180] 0 0
France
State/province [180] 0 0
Le Coudray
Country [181] 0 0
France
State/province [181] 0 0
Lens
Country [182] 0 0
France
State/province [182] 0 0
Limoges Cedex
Country [183] 0 0
France
State/province [183] 0 0
Montpellier
Country [184] 0 0
France
State/province [184] 0 0
NANTES cedex 2
Country [185] 0 0
France
State/province [185] 0 0
Nantes
Country [186] 0 0
France
State/province [186] 0 0
Nice
Country [187] 0 0
France
State/province [187] 0 0
Nîmes
Country [188] 0 0
France
State/province [188] 0 0
Paris Cedex 15
Country [189] 0 0
France
State/province [189] 0 0
Paris
Country [190] 0 0
France
State/province [190] 0 0
Pessac
Country [191] 0 0
France
State/province [191] 0 0
Rennes
Country [192] 0 0
France
State/province [192] 0 0
Saint Brieuc
Country [193] 0 0
France
State/province [193] 0 0
Saint Denis
Country [194] 0 0
France
State/province [194] 0 0
Strasbourg
Country [195] 0 0
France
State/province [195] 0 0
Toulon
Country [196] 0 0
France
State/province [196] 0 0
TOULOUSE cedex
Country [197] 0 0
France
State/province [197] 0 0
Toulouse
Country [198] 0 0
France
State/province [198] 0 0
Tourcoing
Country [199] 0 0
France
State/province [199] 0 0
Valenciennes
Country [200] 0 0
France
State/province [200] 0 0
Vandoeuvre-les-nancy
Country [201] 0 0
Germany
State/province [201] 0 0
Baden-Württemberg
Country [202] 0 0
Germany
State/province [202] 0 0
Hessen
Country [203] 0 0
Germany
State/province [203] 0 0
Niedersachsen
Country [204] 0 0
Germany
State/province [204] 0 0
Nordrhein-Westfalen
Country [205] 0 0
Germany
State/province [205] 0 0
Rheinland-Pfalz
Country [206] 0 0
Germany
State/province [206] 0 0
Saarland
Country [207] 0 0
Germany
State/province [207] 0 0
Sachsen
Country [208] 0 0
Germany
State/province [208] 0 0
Thüringen
Country [209] 0 0
Germany
State/province [209] 0 0
Hamburg
Country [210] 0 0
Greece
State/province [210] 0 0
Attica
Country [211] 0 0
Greece
State/province [211] 0 0
Alexandroupolis
Country [212] 0 0
Greece
State/province [212] 0 0
Athens
Country [213] 0 0
Greece
State/province [213] 0 0
Chaidari
Country [214] 0 0
Greece
State/province [214] 0 0
Elefsina
Country [215] 0 0
Greece
State/province [215] 0 0
Heraklion
Country [216] 0 0
Greece
State/province [216] 0 0
Ioannina
Country [217] 0 0
Greece
State/province [217] 0 0
Larissa
Country [218] 0 0
Greece
State/province [218] 0 0
Marousi
Country [219] 0 0
Greece
State/province [219] 0 0
Nea Ionia
Country [220] 0 0
Greece
State/province [220] 0 0
Patra
Country [221] 0 0
Greece
State/province [221] 0 0
Thessaloniki
Country [222] 0 0
Greece
State/province [222] 0 0
Voula
Country [223] 0 0
Hungary
State/province [223] 0 0
Balatonfured
Country [224] 0 0
Hungary
State/province [224] 0 0
Budapest
Country [225] 0 0
Hungary
State/province [225] 0 0
Debrecen
Country [226] 0 0
Hungary
State/province [226] 0 0
Gyor
Country [227] 0 0
Hungary
State/province [227] 0 0
Gyula
Country [228] 0 0
Hungary
State/province [228] 0 0
Kaposvar
Country [229] 0 0
Hungary
State/province [229] 0 0
Komarom
Country [230] 0 0
Hungary
State/province [230] 0 0
Miskolc
Country [231] 0 0
Hungary
State/province [231] 0 0
Mosonmagyarovar
Country [232] 0 0
Hungary
State/province [232] 0 0
Nagykanizsa
Country [233] 0 0
Hungary
State/province [233] 0 0
Nyiregyhaza
Country [234] 0 0
Hungary
State/province [234] 0 0
Oroshaza
Country [235] 0 0
Hungary
State/province [235] 0 0
Pecs
Country [236] 0 0
Hungary
State/province [236] 0 0
Szekesfehervar
Country [237] 0 0
Hungary
State/province [237] 0 0
Szekszárd
Country [238] 0 0
Hungary
State/province [238] 0 0
Szombathely
Country [239] 0 0
Hungary
State/province [239] 0 0
Zalaegerszeg
Country [240] 0 0
India
State/province [240] 0 0
Kerala
Country [241] 0 0
India
State/province [241] 0 0
Maharashtra
Country [242] 0 0
India
State/province [242] 0 0
Hyderabad
Country [243] 0 0
India
State/province [243] 0 0
Pune
Country [244] 0 0
Israel
State/province [244] 0 0
Afula
Country [245] 0 0
Israel
State/province [245] 0 0
Ashdod
Country [246] 0 0
Israel
State/province [246] 0 0
Ashkelon
Country [247] 0 0
Israel
State/province [247] 0 0
Beer Sheva
Country [248] 0 0
Israel
State/province [248] 0 0
Hadera
Country [249] 0 0
Israel
State/province [249] 0 0
Haifa
Country [250] 0 0
Israel
State/province [250] 0 0
Holon
Country [251] 0 0
Israel
State/province [251] 0 0
Jerusalem
Country [252] 0 0
Israel
State/province [252] 0 0
Lower Galilee
Country [253] 0 0
Israel
State/province [253] 0 0
Nahariya
Country [254] 0 0
Israel
State/province [254] 0 0
Petach Tikva
Country [255] 0 0
Israel
State/province [255] 0 0
Petah Tikva
Country [256] 0 0
Israel
State/province [256] 0 0
Rehovot
Country [257] 0 0
Israel
State/province [257] 0 0
Rishon LeZion
Country [258] 0 0
Israel
State/province [258] 0 0
Tel Aviv
Country [259] 0 0
Israel
State/province [259] 0 0
Zefat
Country [260] 0 0
Italy
State/province [260] 0 0
Abruzzo
Country [261] 0 0
Italy
State/province [261] 0 0
Campania
Country [262] 0 0
Italy
State/province [262] 0 0
Emilia-Romagna
Country [263] 0 0
Italy
State/province [263] 0 0
Lazio
Country [264] 0 0
Italy
State/province [264] 0 0
Lombardia
Country [265] 0 0
Italy
State/province [265] 0 0
Marche
Country [266] 0 0
Italy
State/province [266] 0 0
Piemonte
Country [267] 0 0
Italy
State/province [267] 0 0
Puglia
Country [268] 0 0
Italy
State/province [268] 0 0
Sicilia
Country [269] 0 0
Italy
State/province [269] 0 0
Toscana
Country [270] 0 0
Italy
State/province [270] 0 0
Umbria
Country [271] 0 0
Italy
State/province [271] 0 0
Veneto
Country [272] 0 0
Japan
State/province [272] 0 0
Aichi-ken
Country [273] 0 0
Japan
State/province [273] 0 0
Aichi
Country [274] 0 0
Japan
State/province [274] 0 0
Chiba
Country [275] 0 0
Japan
State/province [275] 0 0
Ehime
Country [276] 0 0
Japan
State/province [276] 0 0
Fukuoka-ken
Country [277] 0 0
Japan
State/province [277] 0 0
Fukuoka
Country [278] 0 0
Japan
State/province [278] 0 0
Fukushima-ken
Country [279] 0 0
Japan
State/province [279] 0 0
Gunma
Country [280] 0 0
Japan
State/province [280] 0 0
Hiroshima
Country [281] 0 0
Japan
State/province [281] 0 0
Hokkaido
Country [282] 0 0
Japan
State/province [282] 0 0
Hyogo
Country [283] 0 0
Japan
State/province [283] 0 0
Ibaraki
Country [284] 0 0
Japan
State/province [284] 0 0
Ishikawa Ken
Country [285] 0 0
Japan
State/province [285] 0 0
Ishikawa
Country [286] 0 0
Japan
State/province [286] 0 0
Iwate
Country [287] 0 0
Japan
State/province [287] 0 0
Kagawa
Country [288] 0 0
Japan
State/province [288] 0 0
Kagoshima
Country [289] 0 0
Japan
State/province [289] 0 0
Kanagawa
Country [290] 0 0
Japan
State/province [290] 0 0
Mie
Country [291] 0 0
Japan
State/province [291] 0 0
Miyagi-ken
Country [292] 0 0
Japan
State/province [292] 0 0
Miyagi
Country [293] 0 0
Japan
State/province [293] 0 0
Nagano-ken
Country [294] 0 0
Japan
State/province [294] 0 0
Nagano
Country [295] 0 0
Japan
State/province [295] 0 0
Okinawa
Country [296] 0 0
Japan
State/province [296] 0 0
Osaka
Country [297] 0 0
Japan
State/province [297] 0 0
Saitama
Country [298] 0 0
Japan
State/province [298] 0 0
Shiga
Country [299] 0 0
Japan
State/province [299] 0 0
Shimane
Country [300] 0 0
Japan
State/province [300] 0 0
Tochigi
Country [301] 0 0
Japan
State/province [301] 0 0
Tokyo
Country [302] 0 0
Japan
State/province [302] 0 0
Yamaguchi
Country [303] 0 0
Japan
State/province [303] 0 0
Yamanashi
Country [304] 0 0
Japan
State/province [304] 0 0
Fukui
Country [305] 0 0
Japan
State/province [305] 0 0
Gifu
Country [306] 0 0
Japan
State/province [306] 0 0
Kochi
Country [307] 0 0
Japan
State/province [307] 0 0
Kumamoto
Country [308] 0 0
Japan
State/province [308] 0 0
Kyoto
Country [309] 0 0
Japan
State/province [309] 0 0
Miyazaki
Country [310] 0 0
Japan
State/province [310] 0 0
Oita
Country [311] 0 0
Japan
State/province [311] 0 0
Okayama
Country [312] 0 0
Japan
State/province [312] 0 0
Saga
Country [313] 0 0
Japan
State/province [313] 0 0
Shizuoka
Country [314] 0 0
Japan
State/province [314] 0 0
Wakayama
Country [315] 0 0
Korea, Republic of
State/province [315] 0 0
Busan Gwang''yeogsi
Country [316] 0 0
Korea, Republic of
State/province [316] 0 0
Daegu Gwang''yeogsi
Country [317] 0 0
Korea, Republic of
State/province [317] 0 0
Gang''weondo
Country [318] 0 0
Korea, Republic of
State/province [318] 0 0
Gyeonggido
Country [319] 0 0
Korea, Republic of
State/province [319] 0 0
Seoul Teugbyeolsi
Country [320] 0 0
Korea, Republic of
State/province [320] 0 0
Busan
Country [321] 0 0
Korea, Republic of
State/province [321] 0 0
Daegu
Country [322] 0 0
Korea, Republic of
State/province [322] 0 0
Gwangju
Country [323] 0 0
Korea, Republic of
State/province [323] 0 0
Incheon
Country [324] 0 0
Korea, Republic of
State/province [324] 0 0
Seoul
Country [325] 0 0
Latvia
State/province [325] 0 0
Daugavpils
Country [326] 0 0
Latvia
State/province [326] 0 0
Kuldiga
Country [327] 0 0
Latvia
State/province [327] 0 0
Liepaja
Country [328] 0 0
Latvia
State/province [328] 0 0
Ogre
Country [329] 0 0
Latvia
State/province [329] 0 0
Riga
Country [330] 0 0
Latvia
State/province [330] 0 0
Valmiera
Country [331] 0 0
Latvia
State/province [331] 0 0
Ventspils
Country [332] 0 0
Lithuania
State/province [332] 0 0
Kaunas
Country [333] 0 0
Lithuania
State/province [333] 0 0
Klaipeda
Country [334] 0 0
Lithuania
State/province [334] 0 0
Siauliai
Country [335] 0 0
Lithuania
State/province [335] 0 0
Vilnius
Country [336] 0 0
Malaysia
State/province [336] 0 0
Alor Setar
Country [337] 0 0
Malaysia
State/province [337] 0 0
Cheras
Country [338] 0 0
Malaysia
State/province [338] 0 0
Johor Bahru
Country [339] 0 0
Malaysia
State/province [339] 0 0
Kelantan
Country [340] 0 0
Malaysia
State/province [340] 0 0
Kuala Lumpur
Country [341] 0 0
Malaysia
State/province [341] 0 0
Pahang
Country [342] 0 0
Malaysia
State/province [342] 0 0
Pulau Pinang
Country [343] 0 0
Malaysia
State/province [343] 0 0
Sarawak
Country [344] 0 0
Malaysia
State/province [344] 0 0
Selangor
Country [345] 0 0
Malaysia
State/province [345] 0 0
Seremban
Country [346] 0 0
Netherlands
State/province [346] 0 0
Zeeland
Country [347] 0 0
Netherlands
State/province [347] 0 0
Amstelveen
Country [348] 0 0
Netherlands
State/province [348] 0 0
Amsterdam
Country [349] 0 0
Netherlands
State/province [349] 0 0
Apeldoorn
Country [350] 0 0
Netherlands
State/province [350] 0 0
Arnhem
Country [351] 0 0
Netherlands
State/province [351] 0 0
Beverwijk
Country [352] 0 0
Netherlands
State/province [352] 0 0
Blaricum
Country [353] 0 0
Netherlands
State/province [353] 0 0
Breda
Country [354] 0 0
Netherlands
State/province [354] 0 0
Den Haag
Country [355] 0 0
Netherlands
State/province [355] 0 0
Dirksland
Country [356] 0 0
Netherlands
State/province [356] 0 0
Dordrecht
Country [357] 0 0
Netherlands
State/province [357] 0 0
Eindhoven
Country [358] 0 0
Netherlands
State/province [358] 0 0
Emmen
Country [359] 0 0
Netherlands
State/province [359] 0 0
Enschede
Country [360] 0 0
Netherlands
State/province [360] 0 0
Gorinchem
Country [361] 0 0
Netherlands
State/province [361] 0 0
Groningen
Country [362] 0 0
Netherlands
State/province [362] 0 0
Haarlem
Country [363] 0 0
Netherlands
State/province [363] 0 0
Hardenberg
Country [364] 0 0
Netherlands
State/province [364] 0 0
Roosendaal
Country [365] 0 0
Netherlands
State/province [365] 0 0
Tiel
Country [366] 0 0
Netherlands
State/province [366] 0 0
Venlo
Country [367] 0 0
Netherlands
State/province [367] 0 0
Zaandam
Country [368] 0 0
Norway
State/province [368] 0 0
Bodø
Country [369] 0 0
Norway
State/province [369] 0 0
Drammen
Country [370] 0 0
Norway
State/province [370] 0 0
Elverum
Country [371] 0 0
Norway
State/province [371] 0 0
Fredrikstad
Country [372] 0 0
Norway
State/province [372] 0 0
Gjettum
Country [373] 0 0
Norway
State/province [373] 0 0
Gjøvik
Country [374] 0 0
Norway
State/province [374] 0 0
Harstad
Country [375] 0 0
Norway
State/province [375] 0 0
Lillehammer
Country [376] 0 0
Norway
State/province [376] 0 0
Molde
Country [377] 0 0
Norway
State/province [377] 0 0
Nordbyhagen
Country [378] 0 0
Norway
State/province [378] 0 0
Oslo
Country [379] 0 0
Norway
State/province [379] 0 0
Skedsmokorset
Country [380] 0 0
Norway
State/province [380] 0 0
Stavanger
Country [381] 0 0
Norway
State/province [381] 0 0
Tromsø
Country [382] 0 0
Norway
State/province [382] 0 0
Ålesund
Country [383] 0 0
Poland
State/province [383] 0 0
Bialystok
Country [384] 0 0
Poland
State/province [384] 0 0
Bydgoszcz
Country [385] 0 0
Poland
State/province [385] 0 0
Gdansk
Country [386] 0 0
Poland
State/province [386] 0 0
Grodzisk Mazowiecki
Country [387] 0 0
Poland
State/province [387] 0 0
Katowice
Country [388] 0 0
Poland
State/province [388] 0 0
Krakow
Country [389] 0 0
Poland
State/province [389] 0 0
Lodz
Country [390] 0 0
Poland
State/province [390] 0 0
Lowicz
Country [391] 0 0
Poland
State/province [391] 0 0
Lublin
Country [392] 0 0
Poland
State/province [392] 0 0
Olsztyn
Country [393] 0 0
Poland
State/province [393] 0 0
Piaseczno
Country [394] 0 0
Poland
State/province [394] 0 0
Piotrkow Trybunalski
Country [395] 0 0
Poland
State/province [395] 0 0
Poznan
Country [396] 0 0
Poland
State/province [396] 0 0
Pulawy
Country [397] 0 0
Poland
State/province [397] 0 0
Rzeszow
Country [398] 0 0
Poland
State/province [398] 0 0
Skierniewice
Country [399] 0 0
Poland
State/province [399] 0 0
Staszow
Country [400] 0 0
Poland
State/province [400] 0 0
Warszawa
Country [401] 0 0
Poland
State/province [401] 0 0
Zamosc
Country [402] 0 0
Portugal
State/province [402] 0 0
Braga
Country [403] 0 0
Portugal
State/province [403] 0 0
Castelo Branco
Country [404] 0 0
Portugal
State/province [404] 0 0
Lisboa
Country [405] 0 0
Portugal
State/province [405] 0 0
Porto
Country [406] 0 0
Portugal
State/province [406] 0 0
Santarém
Country [407] 0 0
Portugal
State/province [407] 0 0
Setúbal
Country [408] 0 0
Portugal
State/province [408] 0 0
Coimbra
Country [409] 0 0
Portugal
State/province [409] 0 0
Guilhufe
Country [410] 0 0
Portugal
State/province [410] 0 0
Leiria
Country [411] 0 0
Portugal
State/province [411] 0 0
Vila Real
Country [412] 0 0
Romania
State/province [412] 0 0
Dolj
Country [413] 0 0
Romania
State/province [413] 0 0
Mures
Country [414] 0 0
Romania
State/province [414] 0 0
Timis
Country [415] 0 0
Romania
State/province [415] 0 0
Baia Mare
Country [416] 0 0
Romania
State/province [416] 0 0
Braila
Country [417] 0 0
Romania
State/province [417] 0 0
Brasov
Country [418] 0 0
Romania
State/province [418] 0 0
Bucharest
Country [419] 0 0
Romania
State/province [419] 0 0
Bucuresti
Country [420] 0 0
Romania
State/province [420] 0 0
Cluj Napoca
Country [421] 0 0
Romania
State/province [421] 0 0
Iasi
Country [422] 0 0
Romania
State/province [422] 0 0
Pitesti
Country [423] 0 0
Romania
State/province [423] 0 0
Satu Mare
Country [424] 0 0
Romania
State/province [424] 0 0
Suceava
Country [425] 0 0
Romania
State/province [425] 0 0
Targu Mures
Country [426] 0 0
Romania
State/province [426] 0 0
Timisoara
Country [427] 0 0
Singapore
State/province [427] 0 0
Singapore
Country [428] 0 0
Slovakia
State/province [428] 0 0
Bardejov
Country [429] 0 0
Slovakia
State/province [429] 0 0
Bratislava
Country [430] 0 0
Slovakia
State/province [430] 0 0
Brezno
Country [431] 0 0
Slovakia
State/province [431] 0 0
Kosice
Country [432] 0 0
Slovakia
State/province [432] 0 0
Levice
Country [433] 0 0
Slovakia
State/province [433] 0 0
Levoca
Country [434] 0 0
Slovakia
State/province [434] 0 0
Lucenec
Country [435] 0 0
Slovakia
State/province [435] 0 0
Namestovo
Country [436] 0 0
Slovakia
State/province [436] 0 0
Nitra
Country [437] 0 0
Slovakia
State/province [437] 0 0
Nove Zamky
Country [438] 0 0
Slovakia
State/province [438] 0 0
Piestany
Country [439] 0 0
Slovakia
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Funding & Sponsors
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Bayer
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Summary
Brief summary
Researchers are looking for a better way to treat people with atrial fibrillation (AF) and prevent stroke or systemic embolism (blood clots travelling through the blood stream to plug another vessel).

Atrial fibrillation is a condition of having irregular and often rapid heartbeat. It can lead to the formation of blood clots in the heart which can travel through the blood stream to plug another vessel, and like this lead to serious and life-threatening conditions, such as a stroke. A stroke occurs because the brain tissue beyond the blockage no longer receives nutrients and oxygen so that brain cells die. As strokes arising from atrial fibrillation can involve extensive areas of the brain, it is important to prevent them.

Blood clots are formed in a process known as coagulation. Medications are already available to prevent the formation of blood clots. When taken by mouth (orally), they are known as oral anticoagulants (OACs) including apixaban. OACs decrease the risk of the above-mentioned serious and life-threatening conditions. The main side effect of OACs is an increase of the risk of bleeding.

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 with regard to the risk of bleeding.

The main purpose of this study is to collect more data about how well asundexian works to prevent stroke and systemic embolism and how safe it is compared to apixaban in people with atrial fibrillation and at high risk for stroke.

To see how well the study treatment asundexian works researchers compare:

* how long asundexian works well and
* how long apixaban works well after the start of the treatment. Working well means that the treatments can prevent the following from happening:
* stroke and/or
* systemic embolism. The study will keep collecting data until a certain number of strokes or embolisms happen in the study.

To see how safe asundexian is, the researchers will compare how often major bleedings occur after taking the study treatments asundexian and apixaban, respectively. Major bleedings are bleedings that have a serious or even life-threatening impact on a person's health.

The study participants will be randomly (by chance) assigned to 1 of 2 treatment groups, A and B. Dependent on the treatment group, the participants will either take the study treatment asundexian by mouth once a day or apixaban by mouth twice a day for approximately 9 - 33 months.

Each participant will be in the study for approximately 9 - 34 months. There will be visits to the study site every 3 to 6 months and up to 7 phone calls. Those participants who do not want or are unable to have visits to the study site may join the study remotely in selected locations. The location name contains the abbreviation - DCT in such cases.

During the study, the study team will:

* take blood samples
* do physical examinations
* examine heart health using an electrocardiogram (ECG)
* check vital signs such as blood pressure and heart rate
* do pregnancy tests
* ask the participants questions about their quality of life
* 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.
Trial website
https://clinicaltrials.gov/study/NCT05643573
Trial related presentations / publications
Public notes

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Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05643573