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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT04304508
Registration number
NCT04304508
Ethics application status
Date submitted
8/03/2020
Date registered
11/03/2020
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.
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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
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Secondary ID [1]
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2019-003431-33
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Secondary ID [2]
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19766
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Universal Trial Number (UTN)
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Trial acronym
PACIFIC-STROKE
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Acute Non-cardioembolic Ischemic Stroke
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Condition category
Condition code
Stroke
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Haemorrhagic
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Stroke
0
0
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Ischaemic
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Neurological
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Other neurological disorders
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Cardiovascular
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0
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Diseases of the vasculature and circulation including the lymphatic system
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
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Treatment: Drugs
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Intervention code [2]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Efficacy-Number of Participants With Composite of Symptomatic Ischemic Stroke or Covert Brain Infarcts Detected by Magnetic Resonance Imaging (MRI)
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Assessment method [1]
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Ischemic stroke was defined as either of : 1) Rapid onset (or present on awakening) of a new focal neurological deficit with clinical (\>24 hours symptoms/signs) or imaging evidence of infarction that was not attributable to a non-ischemic cause; 2) Acute worsening of an existing focal neurological deficit that was judged to be attributable to a new infarction or extension of the previous infarction in the same vascular territory, based on persisting symptoms/signs or imaging evidence of infarction and no evidence of a non-ischemic etiology. If imaging was inconclusive, persistent symptoms/signs must be significant (worsening of NIHSS score of 4 or more) and sustained (duration of =24 hours or until death). Covert brain infarcts were defined as incident infarcts detected by serial MRI in the absence of an adjudicated stroke consistent with the location of the infarct. MRI criteria for brain infarction were available in the MRI procedures manual.
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Timepoint [1]
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From baseline up to 26 weeks
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Primary outcome [2]
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Safety-Number of Participants With Composite of International Society on Thrombosis and Hemostasis (ISTH) Major Bleeding and Clinically Relevant Non-major (CRNM) Bleeding
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Assessment method [2]
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ISTH Major Bleeding criteria: 1. Fatal bleeding, and/or 2. Symptomatic bleeding in a critical area or organ (intracranial, intraocular, intraspinal, pericardial, retroperitoneal, intraarticular, or intramuscular with compartment syndrome), and/or 3. Clinically overt bleeding associated with a recent decrease in the hemoglobin level of = 2 g/dL (20 g/L; 1.24 mmol/L) compared to the most recent hemoglobin value available before the event, and/or 4. Clinically overt bleeding leading to transfusion of 2 or more units of packed red blood cells or whole blood. ISTH Clinically Relevant Non-Major Bleeding is considered any sign or symptom of hemorrhage that does not fit the criteria for the ISTH definition of major bleeding, but does meet at least one of the following criteria 1. requiring medical intervention by a healthcare professional. 2. leading to hospitalization or increased level of care. 3. prompting a face to face (i.e. not just a telephone or electronic communication) evaluation.
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Timepoint [2]
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From baseline up to 52 weeks
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Secondary outcome [1]
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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.
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Assessment method [1]
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CV death included death due to stroke, MI, heart failure or cardiogenic shock, sudden death or any other death due to other cardiovascular causes. Death due to non-traumatic hemorrhage was included. Acute MI was used when there was evidence of myocardial necrosis in a clinical setting consistent with acute myocardial ischemia. According to MI Universal Definition from 2018 the diagnosis of MI required the combination of: 1) Presence of acute myocardial injury, and 2) Evidence of acute myocardial ischemia derived from the clinical presentation, electrocardiographic changes, or the results of myocardial or coronary artery imaging, or in case of post-mortem pathological findings irrespective of biomarker values. Systemic embolism was defined as abrupt vascular insufficiency associated with clinical or radiological evidence of arterial occlusion in the absence of other likely mechanisms (this did not include thromboembolism of the pulmonary vasculature or venous thrombosis).
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Timepoint [1]
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From baseline up to 26 weeks
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Secondary outcome [2]
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Efficacy-Number of Participants With Symptomatic Ischemic Stroke
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Assessment method [2]
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Definition of symptomatic ischemic stroke can be referred to first Primary endpoint.
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Timepoint [2]
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From baseline up to 52 weeks
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Secondary outcome [3]
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Efficacy-Number of Participants With Covert Brain Infarcts Detected by MRI
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Assessment method [3]
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Definition of covert brain infarcts can be referred to first Primary endpoint.
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Timepoint [3]
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From baseline up to 26 weeks
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Secondary outcome [4]
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Efficacy-Number of Participants With Symptomatic Ischemic Stroke, CV Death, MI
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Assessment method [4]
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Definition of symptomatic ischemic stroke can be referred to first Primary endpoint. Definition of CV death and MI can be referred to first Second endpoint.
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Timepoint [4]
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From baseline up to 52 weeks
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Secondary outcome [5]
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Efficacy-Number of Participants With Symptomatic Ischemic and Hemorrhagic Stroke
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Assessment method [5]
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Definition of symptomatic ischemic can be referred to fourth secondary endpoint. Hemorrhagic stroke was defined as an acute, atraumatic extravasation of blood into the brain parenchyma, intraventricular or subarachnoid space with associated neurological symptoms. This did not include microbleeds or hemorrhagic transformation of an ischemic stroke.
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Timepoint [5]
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From baseline up to 52 weeks
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Secondary outcome [6]
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Efficacy-Number of Participants With Disabling Stroke (mRS=4)
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Assessment method [6]
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Modified ranking score (mRS): 0-No symptoms at all; 1-No significant disability despite symptoms; despite symptoms, able to carry out all usual duties and activities; 2-Slight disability; unable to carry out all previous activities but able to look after own affairs without assistance; 3-Moderate disability; requiring some help, but able to walk without assistance; 4-Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance; 5-Severe disability; bedridden, incontinent and requiring constant nursing care and attention; 6-Death.
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Timepoint [6]
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From baseline up to 52 weeks
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Secondary outcome [7]
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Efficacy-Number of Participants With All-cause Mortality
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Assessment method [7]
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Timepoint [7]
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From baseline up to 52 weeks
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Secondary outcome [8]
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Safety-Number of Participants With All Bleeding
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Assessment method [8]
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All bleeding events occurred from first intake of study intervention until 2 days after the last intake of study intervention.
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Timepoint [8]
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From baseline up to 52 weeks
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Secondary outcome [9]
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Safety-Number of Participants With ISTH Major Bleeding
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Assessment method [9]
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Definition of ISTH major bleeding can be referred to second Primary endpoint.
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Timepoint [9]
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From baseline up to 52 weeks
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Secondary outcome [10]
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Safety-Number of Participants With ISTH CRNM Bleeding
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Assessment method [10]
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Definition of ISTH CRNM bleeding can be referred to second Primary endpoint.
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Timepoint [10]
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From baseline up to 52 weeks
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Secondary outcome [11]
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Safety-Number of Participants With ISTH Minor Bleeding
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Assessment method [11]
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All other overt bleeding episodes not meeting the above criteria for ISTH major or CRNM bleeding were classified as minor bleeding (e.g. bleeding from a minor wound that does not prompt a face-to-face evaluation for a physical examination or laboratory testing).
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Timepoint [11]
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From baseline up to 52 weeks
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Secondary outcome [12]
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Safety-Number of Participants With Intracerebral Hemorrhage (Non-traumatic)
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Assessment method [12]
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Non-traumatic intracerebral hemorrhage was defined as a hemorrhagic stroke on the "recurrent stroke" CRF page that is in addition classified as a bleeding with bleeding site intracranial (-subarachnoid, -intraparenchymal \[excluding microbleeds\], or -intraventricular) and spontaneous causality of bleeding, excluding all symptomatic and hemorrhagic transformation (defined by the PT "hemorrhagic transformation").
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Timepoint [12]
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From baseline up to 52 weeks
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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
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Minimum age
45
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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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
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
15/06/2020
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
18/02/2022
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Sample size
Target
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Accrual to date
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Final
1808
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
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Recruitment hospital [1]
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Liverpool Hospital - Liverpool
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Recruitment hospital [2]
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John Hunter Hospital - New Lambton
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Recruitment hospital [3]
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Royal North Shore Hospital - Sydney
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Recruitment hospital [4]
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Sunshine Coast University Hospital - Birtinya
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Recruitment hospital [5]
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Gold Coast University Hospital - Southport
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Recruitment hospital [6]
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Royal Adelaide Hospital - Adelaide
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Recruitment hospital [7]
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Grampians Health Ballarat - Ballarat
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Recruitment hospital [8]
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Eastern Clinical Research Unit - Box Hill - Box Hill
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Recruitment hospital [9]
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Royal Melbourne Hospital - Parkville
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Recruitment hospital [10]
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The Alfred Hospital - Prahran
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Recruitment hospital [11]
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Fiona Stanley Hospital - Murdoch
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Recruitment postcode(s) [1]
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2170 - Liverpool
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Recruitment postcode(s) [2]
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2305 - New Lambton
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Recruitment postcode(s) [3]
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2065 - Sydney
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Recruitment postcode(s) [4]
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4575 - Birtinya
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Recruitment postcode(s) [5]
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4215 - Southport
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Recruitment postcode(s) [6]
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5000 - Adelaide
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Recruitment postcode(s) [7]
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3350 - Ballarat
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Recruitment postcode(s) [8]
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3128 - Box Hill
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Recruitment postcode(s) [9]
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3052 - Parkville
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Recruitment postcode(s) [10]
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3004 - Prahran
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Recruitment postcode(s) [11]
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6961 - Murdoch
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Recruitment outside Australia
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United States of America
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Florida
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Minnesota
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Missouri
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Austria
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Oberösterreich
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Austria
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Tirol
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Salzburg
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Limburg
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Aichi
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Fukuoka
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Fukushima
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Hyogo
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Ibaraki
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Kanagawa
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Kyoto
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Osaka
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Tokyo
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Gifu
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Nagano
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Netherlands
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Amsterdam
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Heerlen
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Zwolle
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Poland
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Grodzisk Mazowiecki
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Katowice
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Krakow
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Lublin
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Warszawa
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Portugal
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Lisboa
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Porto
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Portugal
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Setúbal
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Portugal
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Coimbra
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Russian Federation
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Chelyabinsk
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Russian Federation
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Kemerovo
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Russian Federation
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Krasnodar
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Russian Federation
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Novosibirsk
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Sestroretsk
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Russian Federation
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Tomsk
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Russian Federation
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Vsevolozhsk
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Russian Federation
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Yekaterinburg
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Slovakia
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Bratislava
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Dolny Kubin
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Levoca
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Liptovsky Mikulas
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Rimavska Sobota
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Skalica
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Spisska Nova Ves
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Trnava
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Ziar nad Hronom
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Spain
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A Coruña
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Barcelona
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Madrid
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Albacete
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Lleida
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Valencia
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Spain
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Valladolid
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Sweden
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Lund
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Sweden
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Stockholm
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Sweden
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Umeå
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Basel-Stadt
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Bern
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Baden
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United Kingdom
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Cheshire
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Cambridge
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Coventry
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London
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Bayer
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Address
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Other collaborator category [1]
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Other
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Population Health Research Institute
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Ethics approval
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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.
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Trial website
https://clinicaltrials.gov/study/NCT04304508
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Trial related presentations / publications
Shoamanesh A, Mundl H, Smith EE, Masjuan J, Milanov I, Hirano T, Agafina A, Campbell B, Caso V, Mas JL, Dong Q, Turcani P, Christensen H, Ferro JM, Veltkamp R, Mikulik R, De Marchis GM, Robinson T, Lemmens R, Stepien A, Greisenegger S, Roine R, Csiba L, Khatri P, Coutinho J, Lindgren AG, Demchuk AM, Colorado P, Kirsch B, Neumann C, Heenan L, Xu L, Connolly SJ, Hart RG; PACIFIC-Stroke Investigators. Factor XIa inhibition with asundexian after acute non-cardioembolic ischaemic stroke (PACIFIC-Stroke): an international, randomised, double-blind, placebo-controlled, phase 2b trial. Lancet. 2022 Sep 24;400(10357):997-1007. doi: 10.1016/S0140-6736(22)01588-4. Epub 2022 Sep 2.
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Public notes
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Contacts
Principal investigator
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
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No/undecided IPD sharing reason/comment
Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access.
As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.
Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.
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What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/08/NCT04304508/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/08/NCT04304508/SAP_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT04304508