Trial Review

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/NCT04304508




Registration number
NCT04304508
Ethics application status
Date submitted
8/03/2020
Date registered
11/03/2020
Date last updated
19/04/2023

Titles & IDs
Public title
Study to Gather Information About Proper Dosing and Safety of the Oral FXIa Inhibitor BAY 2433334 in Patients Following a Recent Non Cardioembolic Ischemic Stroke Which Occurs When a Blood Clot Has Formed Somewhere in the Human Body (But Not in the Heart) Travelled to the Brain.
Scientific title
Multicenter, Randomized, Placebo-controlled, Double-blind, Parallel Group, Dose-finding Phase 2 Study to Evaluate Efficacy and Safety of BAY2433334 in Patients Following an Acute Non-cardioembolic Ischemic Stroke
Secondary ID [1] 0 0
2019-003431-33
Secondary ID [2] 0 0
19766
Universal Trial Number (UTN)
Trial acronym
PACIFIC-STROKE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Non-cardioembolic Ischemic Stroke 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 - BAY2433334
Other interventions - BAY2433334 matching placebo

Experimental: BAY2433334 high dose -

Experimental: BAY2433334 medium dose -

Experimental: BAY2433334 low dose -

Placebo Comparator: BAY2433334 matching placebo -


Treatment: Drugs: BAY2433334
Tablet, taken orally once a day.

Other interventions: BAY2433334 matching placebo
Tablet, taken orally once a day.
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
Efficacy-Number of Participants With Composite of Symptomatic Ischemic Stroke or Covert Brain Infarcts Detected by Magnetic Resonance Imaging (MRI)
Timepoint [1] 0 0
From baseline up to 26 weeks
Primary outcome [2] 0 0
Safety-Number of Participants With Composite of International Society on Thrombosis and Hemostasis (ISTH) Major Bleeding and Clinically Relevant Non-major (CRNM) Bleeding
Timepoint [2] 0 0
From baseline up to 52 weeks
Secondary outcome [1] 0 0
Efficacy-Number of Participants With Composite of Symptomatic Ischemic Stroke and Covert Brain Infarcts Detected by MRI, Cardiovascular (CV) Death, Myocardial Infarction (MI) and Systemic Embolism.
Timepoint [1] 0 0
From baseline up to 26 weeks
Secondary outcome [2] 0 0
Efficacy-Number of Participants With Symptomatic Ischemic Stroke
Timepoint [2] 0 0
From baseline up to 52 weeks
Secondary outcome [3] 0 0
Efficacy-Number of Participants With Covert Brain Infarcts Detected by MRI
Timepoint [3] 0 0
From baseline up to 26 weeks
Secondary outcome [4] 0 0
Efficacy-Number of Participants With Symptomatic Ischemic Stroke, CV Death, MI
Timepoint [4] 0 0
From baseline up to 52 weeks
Secondary outcome [5] 0 0
Efficacy-Number of Participants With Symptomatic Ischemic and Hemorrhagic Stroke
Timepoint [5] 0 0
From baseline up to 52 weeks
Secondary outcome [6] 0 0
Efficacy-Number of Participants With Disabling Stroke (mRS=4)
Timepoint [6] 0 0
From baseline up to 52 weeks
Secondary outcome [7] 0 0
Efficacy-Number of Participants With All-cause Mortality
Timepoint [7] 0 0
From baseline up to 52 weeks
Secondary outcome [8] 0 0
Safety-Number of Participants With All Bleeding
Timepoint [8] 0 0
From baseline up to 52 weeks
Secondary outcome [9] 0 0
Safety-Number of Participants With ISTH Major Bleeding
Timepoint [9] 0 0
From baseline up to 52 weeks
Secondary outcome [10] 0 0
Safety-Number of Participants With ISTH CRNM Bleeding
Timepoint [10] 0 0
From baseline up to 52 weeks
Secondary outcome [11] 0 0
Safety-Number of Participants With ISTH Minor Bleeding
Timepoint [11] 0 0
From baseline up to 52 weeks
Secondary outcome [12] 0 0
Safety-Number of Participants With Intracerebral Hemorrhage (Non-traumatic)
Timepoint [12] 0 0
From baseline up to 52 weeks

Eligibility
Key inclusion criteria
- Participant must be 45 years of age and older at the time of signing the informed
consent

- Non-cardioembolic ischemic stroke with

- persistent signs and symptoms of stroke lasting for = 24 hours OR

- acute brain infarction documented by computed tomography (CT) or MRI AND

- with the intention to be treated with antiplatelet therapy during the study
conduct

- Imaging of brain (CT or MRI) ruling out hemorrhagic stroke or another pathology that
could explain symptoms (e.g. brain tumor, abscess, vascular malformation)

- Severity of index event nearest the time of randomization:

- Part A: minor stroke (defined as National Institutes of Health Stroke Scale
(NIHSS) = 7) can be enrolled

- Part B: participants with minor or moderate stroke and NIHSS = 15 can be
enrolled. Participants undergoing thrombolysis or endovascular therapy
(mechanical thrombectomy) can be enrolled but at the earliest 24 hours after the
intervention

- Randomization within 48 hours after the onset of symptoms of the index event (or after
patients were last known to be without symptoms in case of wake-up stroke)

- Ability to conduct an MRI either before randomization or within 72 hours after
randomization
Minimum age
45 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Prior ischemic stroke within last 30 days of index event

- History of atrial fibrillation or suspicion of cardioembolic source of stroke

- Dysphagia with inability to safely swallow study medication

- Contraindication to perform brain MRI

- Part A only: thrombolysis or endovascular therapy (mechanical thrombectomy) performed
for index event

- Active bleeding; known bleeding disorder, history of major bleeding (intracranial,
retroperitoneal, intraocular) or clinically significant gastrointestinal bleeding
within last 6 months of randomization.

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 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
15/06/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
18/02/2022
Sample size
Target
Accrual to date
Final
1808
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Liverpool Hospital - Liverpool
Recruitment hospital [2] 0 0
John Hunter Hospital - New Lambton
Recruitment hospital [3] 0 0
Royal North Shore Hospital - Sydney
Recruitment hospital [4] 0 0
Sunshine Coast University Hospital - Birtinya
Recruitment hospital [5] 0 0
Gold Coast University Hospital - Southport
Recruitment hospital [6] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [7] 0 0
Grampians Health Ballarat - Ballarat
Recruitment hospital [8] 0 0
Eastern Clinical Research Unit - Box Hill - Box Hill
Recruitment hospital [9] 0 0
Royal Melbourne Hospital - Parkville
Recruitment hospital [10] 0 0
The Alfred Hospital - Prahran
Recruitment hospital [11] 0 0
Fiona Stanley Hospital - Murdoch
Recruitment postcode(s) [1] 0 0
2170 - Liverpool
Recruitment postcode(s) [2] 0 0
2305 - New Lambton
Recruitment postcode(s) [3] 0 0
2065 - Sydney
Recruitment postcode(s) [4] 0 0
4575 - Birtinya
Recruitment postcode(s) [5] 0 0
4215 - Southport
Recruitment postcode(s) [6] 0 0
5000 - Adelaide
Recruitment postcode(s) [7] 0 0
3350 - Ballarat
Recruitment postcode(s) [8] 0 0
3128 - Box Hill
Recruitment postcode(s) [9] 0 0
3052 - Parkville
Recruitment postcode(s) [10] 0 0
3004 - Prahran
Recruitment postcode(s) [11] 0 0
6961 - Murdoch
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Florida
Country [2] 0 0
United States of America
State/province [2] 0 0
Minnesota
Country [3] 0 0
United States of America
State/province [3] 0 0
Missouri
Country [4] 0 0
United States of America
State/province [4] 0 0
North Carolina
Country [5] 0 0
United States of America
State/province [5] 0 0
Pennsylvania
Country [6] 0 0
Austria
State/province [6] 0 0
Burgenland
Country [7] 0 0
Austria
State/province [7] 0 0
Oberösterreich
Country [8] 0 0
Austria
State/province [8] 0 0
Tirol
Country [9] 0 0
Austria
State/province [9] 0 0
Salzburg
Country [10] 0 0
Austria
State/province [10] 0 0
Wien
Country [11] 0 0
Belgium
State/province [11] 0 0
Limburg
Country [12] 0 0
Belgium
State/province [12] 0 0
Liège
Country [13] 0 0
Belgium
State/province [13] 0 0
Brasschaat
Country [14] 0 0
Belgium
State/province [14] 0 0
Brussel
Country [15] 0 0
Belgium
State/province [15] 0 0
Leuven
Country [16] 0 0
Belgium
State/province [16] 0 0
Oostende
Country [17] 0 0
Belgium
State/province [17] 0 0
Roeselare
Country [18] 0 0
Belgium
State/province [18] 0 0
Uccle
Country [19] 0 0
Bulgaria
State/province [19] 0 0
Haskovo
Country [20] 0 0
Bulgaria
State/province [20] 0 0
Pleven
Country [21] 0 0
Bulgaria
State/province [21] 0 0
Plovdiv
Country [22] 0 0
Bulgaria
State/province [22] 0 0
Ruse
Country [23] 0 0
Bulgaria
State/province [23] 0 0
Sofia
Country [24] 0 0
Bulgaria
State/province [24] 0 0
Varna
Country [25] 0 0
China
State/province [25] 0 0
Heilongjiang
Country [26] 0 0
China
State/province [26] 0 0
Inner Mongolia
Country [27] 0 0
China
State/province [27] 0 0
Jiangsu
Country [28] 0 0
China
State/province [28] 0 0
Jilin
Country [29] 0 0
China
State/province [29] 0 0
Sichuan
Country [30] 0 0
China
State/province [30] 0 0
Shanghai
Country [31] 0 0
China
State/province [31] 0 0
Tianjin
Country [32] 0 0
Czechia
State/province [32] 0 0
Brno
Country [33] 0 0
Czechia
State/province [33] 0 0
Ceske Budejovice
Country [34] 0 0
Czechia
State/province [34] 0 0
Hradec Kralove
Country [35] 0 0
Czechia
State/province [35] 0 0
Jihlava
Country [36] 0 0
Czechia
State/province [36] 0 0
Ostrava Vitkovice
Country [37] 0 0
Czechia
State/province [37] 0 0
Ostrava-Poruba
Country [38] 0 0
Czechia
State/province [38] 0 0
Pardubice
Country [39] 0 0
Czechia
State/province [39] 0 0
Praha 10
Country [40] 0 0
Czechia
State/province [40] 0 0
Praha 5-Motol
Country [41] 0 0
Denmark
State/province [41] 0 0
Aalborg
Country [42] 0 0
Denmark
State/province [42] 0 0
Aarhus N
Country [43] 0 0
Denmark
State/province [43] 0 0
Copenhagen
Country [44] 0 0
Denmark
State/province [44] 0 0
Glostrup
Country [45] 0 0
Denmark
State/province [45] 0 0
Herlev
Country [46] 0 0
Denmark
State/province [46] 0 0
Herning
Country [47] 0 0
Denmark
State/province [47] 0 0
Hillerød
Country [48] 0 0
Denmark
State/province [48] 0 0
Kolding
Country [49] 0 0
Finland
State/province [49] 0 0
Helsinki
Country [50] 0 0
Finland
State/province [50] 0 0
Kuopio
Country [51] 0 0
Finland
State/province [51] 0 0
Turku
Country [52] 0 0
France
State/province [52] 0 0
Besancon
Country [53] 0 0
France
State/province [53] 0 0
Bordeaux
Country [54] 0 0
France
State/province [54] 0 0
Le Kremlin-bicetre
Country [55] 0 0
France
State/province [55] 0 0
Le Mans
Country [56] 0 0
France
State/province [56] 0 0
Lille
Country [57] 0 0
France
State/province [57] 0 0
Nancy
Country [58] 0 0
France
State/province [58] 0 0
PARIS cedex 14
Country [59] 0 0
France
State/province [59] 0 0
Paris
Country [60] 0 0
France
State/province [60] 0 0
Rennes Cedex
Country [61] 0 0
France
State/province [61] 0 0
Toulouse
Country [62] 0 0
Germany
State/province [62] 0 0
Baden-Württemberg
Country [63] 0 0
Germany
State/province [63] 0 0
Bayern
Country [64] 0 0
Germany
State/province [64] 0 0
Hessen
Country [65] 0 0
Germany
State/province [65] 0 0
Niedersachsen
Country [66] 0 0
Germany
State/province [66] 0 0
Nordrhein-Westfalen
Country [67] 0 0
Germany
State/province [67] 0 0
Sachsen
Country [68] 0 0
Germany
State/province [68] 0 0
Thüringen
Country [69] 0 0
Hungary
State/province [69] 0 0
Budapest
Country [70] 0 0
Hungary
State/province [70] 0 0
Debrecen
Country [71] 0 0
Hungary
State/province [71] 0 0
Kistarcsa
Country [72] 0 0
Hungary
State/province [72] 0 0
Pecs
Country [73] 0 0
Hungary
State/province [73] 0 0
Szeged
Country [74] 0 0
Hungary
State/province [74] 0 0
Zalaegerszeg
Country [75] 0 0
Italy
State/province [75] 0 0
Emilia-Romagna
Country [76] 0 0
Italy
State/province [76] 0 0
Lazio
Country [77] 0 0
Italy
State/province [77] 0 0
Lombardia
Country [78] 0 0
Italy
State/province [78] 0 0
Marche
Country [79] 0 0
Italy
State/province [79] 0 0
Toscana
Country [80] 0 0
Italy
State/province [80] 0 0
Umbria
Country [81] 0 0
Japan
State/province [81] 0 0
Aichi
Country [82] 0 0
Japan
State/province [82] 0 0
Fukuoka
Country [83] 0 0
Japan
State/province [83] 0 0
Fukushima
Country [84] 0 0
Japan
State/province [84] 0 0
Hokkaido
Country [85] 0 0
Japan
State/province [85] 0 0
Hyogo
Country [86] 0 0
Japan
State/province [86] 0 0
Ibaraki
Country [87] 0 0
Japan
State/province [87] 0 0
Kanagawa
Country [88] 0 0
Japan
State/province [88] 0 0
Kyoto
Country [89] 0 0
Japan
State/province [89] 0 0
Osaka
Country [90] 0 0
Japan
State/province [90] 0 0
Tokyo
Country [91] 0 0
Japan
State/province [91] 0 0
Gifu
Country [92] 0 0
Japan
State/province [92] 0 0
Hiroshima
Country [93] 0 0
Japan
State/province [93] 0 0
Kochi
Country [94] 0 0
Japan
State/province [94] 0 0
Kumamoto
Country [95] 0 0
Japan
State/province [95] 0 0
Nagano
Country [96] 0 0
Netherlands
State/province [96] 0 0
Amsterdam
Country [97] 0 0
Netherlands
State/province [97] 0 0
Heerlen
Country [98] 0 0
Netherlands
State/province [98] 0 0
Nieuwegein
Country [99] 0 0
Netherlands
State/province [99] 0 0
Zwolle
Country [100] 0 0
Poland
State/province [100] 0 0
Gdansk
Country [101] 0 0
Poland
State/province [101] 0 0
Grodzisk Mazowiecki
Country [102] 0 0
Poland
State/province [102] 0 0
Katowice
Country [103] 0 0
Poland
State/province [103] 0 0
Krakow
Country [104] 0 0
Poland
State/province [104] 0 0
Lublin
Country [105] 0 0
Poland
State/province [105] 0 0
Ostroleka
Country [106] 0 0
Poland
State/province [106] 0 0
Warszawa
Country [107] 0 0
Portugal
State/province [107] 0 0
Lisboa
Country [108] 0 0
Portugal
State/province [108] 0 0
Porto
Country [109] 0 0
Portugal
State/province [109] 0 0
Setúbal
Country [110] 0 0
Portugal
State/province [110] 0 0
Coimbra
Country [111] 0 0
Russian Federation
State/province [111] 0 0
Chelyabinsk
Country [112] 0 0
Russian Federation
State/province [112] 0 0
Kemerovo
Country [113] 0 0
Russian Federation
State/province [113] 0 0
Krasnodar
Country [114] 0 0
Russian Federation
State/province [114] 0 0
Novosibirsk
Country [115] 0 0
Russian Federation
State/province [115] 0 0
Sestroretsk
Country [116] 0 0
Russian Federation
State/province [116] 0 0
Tomsk
Country [117] 0 0
Russian Federation
State/province [117] 0 0
Vsevolozhsk
Country [118] 0 0
Russian Federation
State/province [118] 0 0
Yekaterinburg
Country [119] 0 0
Slovakia
State/province [119] 0 0
Bratislava
Country [120] 0 0
Slovakia
State/province [120] 0 0
Dolny Kubin
Country [121] 0 0
Slovakia
State/province [121] 0 0
Levoca
Country [122] 0 0
Slovakia
State/province [122] 0 0
Liptovsky Mikulas
Country [123] 0 0
Slovakia
State/province [123] 0 0
Rimavska Sobota
Country [124] 0 0
Slovakia
State/province [124] 0 0
Skalica
Country [125] 0 0
Slovakia
State/province [125] 0 0
Spisska Nova Ves
Country [126] 0 0
Slovakia
State/province [126] 0 0
Trnava
Country [127] 0 0
Slovakia
State/province [127] 0 0
Ziar nad Hronom
Country [128] 0 0
Spain
State/province [128] 0 0
A Coruña
Country [129] 0 0
Spain
State/province [129] 0 0
Barcelona
Country [130] 0 0
Spain
State/province [130] 0 0
Madrid
Country [131] 0 0
Spain
State/province [131] 0 0
Albacete
Country [132] 0 0
Spain
State/province [132] 0 0
Lleida
Country [133] 0 0
Spain
State/province [133] 0 0
Sevilla
Country [134] 0 0
Spain
State/province [134] 0 0
Valencia
Country [135] 0 0
Spain
State/province [135] 0 0
Valladolid
Country [136] 0 0
Sweden
State/province [136] 0 0
Lund
Country [137] 0 0
Sweden
State/province [137] 0 0
Stockholm
Country [138] 0 0
Sweden
State/province [138] 0 0
Umeå
Country [139] 0 0
Switzerland
State/province [139] 0 0
Basel-Stadt
Country [140] 0 0
Switzerland
State/province [140] 0 0
Bern
Country [141] 0 0
Switzerland
State/province [141] 0 0
Sankt Gallen
Country [142] 0 0
Switzerland
State/province [142] 0 0
Baden
Country [143] 0 0
Switzerland
State/province [143] 0 0
Lugano
Country [144] 0 0
United Kingdom
State/province [144] 0 0
Cheshire
Country [145] 0 0
United Kingdom
State/province [145] 0 0
Merseyside
Country [146] 0 0
United Kingdom
State/province [146] 0 0
Tyne And Wear
Country [147] 0 0
United Kingdom
State/province [147] 0 0
Cambridge
Country [148] 0 0
United Kingdom
State/province [148] 0 0
Coventry
Country [149] 0 0
United Kingdom
State/province [149] 0 0
Glasgow
Country [150] 0 0
United Kingdom
State/province [150] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Bayer
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Population Health Research Institute
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to try to find the best dose of the new drug BAY 2433334 to give
to participants and to look at how well BAY 2433334 works on top of antiplatelet therapy in
patients following a recent non cardioembolic ischemic stroke which occurs when a blood clot
that has not formed in the heart travelled to the brain. BAY 2433334, works by blocking a
step of the blood clotting process in our body and thins the blood and is a so called oral
FXIa inhibitor.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04304508
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
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04304508