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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT03766581
Registration number
NCT03766581
Ethics application status
Date submitted
13/11/2018
Date registered
6/12/2018
Date last updated
12/06/2023
Titles & IDs
Public title
A Study on BMS-986177 for the Prevention of a Stroke in Patients Receiving Aspirin and Clopidogrel
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Scientific title
A Global, Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study of BMS-986177, an Oral Factor XIa Inhibitor, for the Prevention of New Ischemic Stroke or New Covert Brain Infarction in Patients Receiving Aspirin and Clopidogrel Following Acute Ischemic Stroke or Transient Ischemic Attack (TIA)
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Secondary ID [1]
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0
CV010-031
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Universal Trial Number (UTN)
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Trial acronym
AXIOMATIC-SSP
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Acute Ischemic Stroke
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Transient Ischemic Attack (TIA)
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Condition category
Condition code
Stroke
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0
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Haemorrhagic
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Stroke
0
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0
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Ischaemic
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Cardiovascular
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Diseases of the vasculature and circulation including the lymphatic system
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Neurological
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Other neurological disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - BMS-986177
Other interventions - Placebo
Treatment: Drugs - Clopidogrel
Treatment: Drugs - Aspirin
Placebo comparator: BMS-986177 Placebo - Specified Dose on Specified Days
Experimental: Dose 1: BMS-986177 + Aspirin + Clopidogrel - Specified Dose on Specified Days
Experimental: Dose 2: BMS-986177 + Aspirin + Clopidogrel - Specified Dose on Specified Days
Experimental: Dose 3: BMS-986177 + Aspirin + Clopidogrel - Specified Dose on Specified Days
Experimental: Dose 4: BMS-986177 + Aspirin + Clopidogrel - Specified Dose on Specified Days
Experimental: Dose 5: BMS-986177 + Aspirin + Clopidogrel - Specified Dose on Specified Days
Experimental: Dose 6: BMS-986177 + Aspirin + Clopidogrel - Specified Dose on Specified Days
Experimental: Dose 7: BMS-986177 + Aspirin + Clopidogrel - Specified Dose on Specified Days
Treatment: Drugs: BMS-986177
Oral administration
Other interventions: Placebo
Oral Administration
Treatment: Drugs: Clopidogrel
Oral administration
Treatment: Drugs: Aspirin
Oral administration
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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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Percent of Participants With Model Based Assessment of Composite of New Ischemic Stroke During Treatment and New Covert Brain Infarction (FLAIR + DWI) Detected by MRI by Day 90
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Assessment method [1]
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Model based assessment estimate for composite event is a customized statistical analysis called MCP-MOD (Multiple Comparison Procedures, MODel) estimation, which is used to check for dose-response relationship. 95% confidence interval (CI) for composite event based on bootstrap (10000 samples).
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Timepoint [1]
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From randomization to up to 90 days after randomization
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Secondary outcome [1]
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Percent of Participants With Major Bleeding According to BARC Type 3 and 5
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Assessment method [1]
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Percent of participants with major bleeding based on the Bleeding Academic Research Consortium (BARC) Types 3 and 5 definitions. BARC bleeding types:
3a = Overt bleeding plus hemoglobin drop of 3 to \< 5 g/dL transfusion with overt bleeding 3b = Overt bleeding plus hemoglobin drop =5 g/dL; cardiac tamponade; bleeding requiring surgical intervention for control; bleeding requiring IV vasoactive agents 3c = Intracranial hemorrhage, 5a = Probable fatal bleeding 5b = Definite fatal bleeding
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Timepoint [1]
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From first dose to up to 107 days after first dose
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Secondary outcome [2]
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Number of Participants With Bleeding Based on BARC Types 1-5
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Assessment method [2]
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Number of participants with bleeding based on Bleeding Academic Research Consortium (BARC) Type 1 to 5. BARC bleeding types: 0=No bleeding. 1=Not actionable bleeding. 2=Overt, actionable sign of hemorrhage requiring nonsurgical, medical intervention by a health-care professional, leading to hospitalization or increased level of care, or prompting evaluation. 3a=Overt bleeding plus hemoglobin drop of 3 to \< 5 g/dL. 3b=Overt bleeding plus hemoglobin drop =5 g/dL; cardiac tamponade; bleeding requiring surgical intervention; bleeding requiring IV vasoactive agents. 3c=Intracranial hemorrhage; intraocular bleed compromising vision. 4=CABG-related bleeding, perioperative intracranial bleeding within 48 hours, reoperation after closure of sternotomy to control bleeding, transfusion of =5 U whole blood or packed red blood cells within a 48-hour period, chest tube output more than or equal to 2L within a 24-hour period. 5a=Probable fatal bleeding. 5b=Definite fatal bleeding.
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Timepoint [2]
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From first dose to up to 107 days after first dose
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Secondary outcome [3]
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Number of Participants With Bleeding Based on ISTH-Defined Criteria
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Assessment method [3]
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Number of participants with bleeding based on International Society on Thrombosis and Hemostasis (ISTH). ISTH Bleeding Types: 1) Fatal bleeding and/or 2) Symptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intraarticular or pericardial, or intramuscular with compartment syndrome and/or 3) Bleeding causing a fall in hemoglobin level of =2 g/dL, or leading to transfusion of =2 units of whole blood or red cells.
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Timepoint [3]
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From first dose to up to 107 days after first dose
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Secondary outcome [4]
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Number of Participants With Bleeding Based on PLATO-Defined Criteria
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Assessment method [4]
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Number of participants with bleeding based on Platelet Inhibition and Patient Outcomes (PLATO) defined criteria. PLATO bleeding definitions:
1. Major Life-threatening: Fatal, Intracranial, Intrapericardial with cardiac tamponade, Resulting in hypovolemic shock or severe hypotension that requires pressors or surgery, Clinically overt or apparent bleeding associated with decrease in hemoglobin \>5 g/dL, Requiring transfusion of =4 U whole blood or packed red blood cells (PRBCs)
2. Other Major: Significantly disabling (eg, intraocular with permanent vision loss), Associated drop in hemoglobin of 3 to 5 g/dL, Requiring transfusion of 2 to 3 U whole blood or PRBCs
3. Any Major: Any one of the above criteria
4. Minor: Bleeding that does not meet criteria for PLATO Major bleeding, and requiring medical intervention
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Timepoint [4]
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0
From first dose to up to 107 days after first dose
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Secondary outcome [5]
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Percent of Participants With Descriptive Assessment of Composite of New Ischemic Stroke During Treatment and New Covert Brain Infarction (FLAIR + DWI) Detected by MRI by Day 90
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Assessment method [5]
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Descriptive Assessment of Composite of New Ischemic Stroke During Treatment and New Covert Brain Infarction (FLAIR + DWI) Detected by MRI by Day 90.
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Timepoint [5]
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From randomization to up to 90 days after randomization
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Secondary outcome [6]
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Composite of Percent of Participants With New Ischemic Stroke, MI and All Cause Death
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Assessment method [6]
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Composite of percent of participants of new ischemic stroke, (Myocardial Infarction) MI and all cause death.
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Timepoint [6]
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From randomization to up to 90 days after randomization
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Secondary outcome [7]
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National Institutes of Health Stroke Scale (NIHSS)
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Assessment method [7]
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The NIHSS is an 11-item neurologic examination stroke scale used to evaluate the effect of acute cerebral infarction on the levels of consciousness, language, neglect, visual-field loss, extraocular movement, motor strength, ataxia, dysarthria, and sensory loss. A trained observer rates the patent's ability to answer questions and perform activities. The score for each ability is a number between 0 and 4, 0 being normal functioning and 4 being completely impaired. The patient's NIHSS score is calculated by adding the number for each element of the scale; 42 is the highest score possible. In the NIHSS, the higher the score, the more impaired a stroke participant is.
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Timepoint [7]
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At baseline, on Days 21 and 90, and at the time of a new stroke event
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Secondary outcome [8]
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Modified Rankin Scale (mRS)
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Assessment method [8]
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The Modified Rankin Score (mRS) is a 6-point disability scale with possible scores ranging from 0 to 6.
0 = No symptoms at all
1. = No significant disability 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 and attend to bodily needs without assistance
5. = Severe disability; bedridden, incontinent and requiring constant nursing care and attention
6. = Dead
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Timepoint [8]
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At baseline, on Days 21 and 90, and at the time of a new stroke event
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Secondary outcome [9]
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Montreal Cognitive Assessment (MoCA)
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Assessment method [9]
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The Montreal Cognitive Assessment (MoCA) is a survey with a summed score. MoCA score ranges between a lowest score of 0 to a highest score of 30. A score of:
* =26 points: indicates normal cognitive function
* 18-25 points: Mild cognitive impairment
* 10-17 points: Moderate cognitive impairment
* fewer than 10 points: Severe cognitive impairment
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Timepoint [9]
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At baseline, on Days 21 and 90, and at the time of a new stroke event
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Secondary outcome [10]
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Digit Symbol Substitution Test (DSST)
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Assessment method [10]
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The Descriptive Summary of the Digit Symbol Substitution Test (DSST) is a scale item, with a lowest score of 0 and highest total score of 135. Higher score indicates better cognitive functioning.
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Timepoint [10]
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At baseline, on Days 21 and 90, and at the time of a new stroke event
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Secondary outcome [11]
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Number of Participants With Adverse Events (AEs)
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Assessment method [11]
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AE: include all non-serious adverse events with onset on or after first dose date and within 2 days after the last dose of study treatment.
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Timepoint [11]
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From first dose to 2 days after last dose of study therapy (up to approximately 107 days)
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Secondary outcome [12]
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Number of Participants With Clinically Significant Vital Sign Abnormalities
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Assessment method [12]
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Number of participants with clinically significant vital sign abnormalities. Vital signs included heart rate and diastolic and systolic blood pressure.
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Timepoint [12]
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From first dose to up to 90 days after first dose
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Secondary outcome [13]
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Number of Participants With Clinically Significant Physical Examination Abnormalities
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Assessment method [13]
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Number of participants with clinically significant physical examination abnormalities.
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Timepoint [13]
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From first dose to up to 90 days after first dose
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Secondary outcome [14]
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Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities
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Assessment method [14]
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Number of participants with clinically significant ECG abnormalities.
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Timepoint [14]
0
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From first dose to up to 90 days after first dose
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Secondary outcome [15]
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Number of Participants With Clinically Significant Laboratory Abnormalities - Liver
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Assessment method [15]
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The number of treated participants who experienced a laboratory abnormality of the liver during the course of the study.
Aspartate aminotransferase (AST) Alanine aminotransferase (ALT) Upper Limit of Normal (ULN) Results reported in International System of Units (SI)
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Timepoint [15]
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0
From first dose to up to approximately 38 months
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Secondary outcome [16]
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Percent Change From Baseline in aPTT Activity
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Assessment method [16]
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Percent change from baseline in activated partial thromboplastin time (aPTT) activity via exposure response.
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Timepoint [16]
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Baseline and day 90
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Secondary outcome [17]
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Percent Change From Baseline in Factor XI Clotting Activity
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Assessment method [17]
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Percent change from baseline in factor XI clotting activity via exposure response.
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Timepoint [17]
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Baseline and day 90
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Secondary outcome [18]
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Pharmacokinetic Parameter - Estimated Clearance (CL)
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Assessment method [18]
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Pharmacokinetic Parameter - Estimated Clearance (CL). CL is derived from plasma concentration versus time data. PK parameters were generated using a Population Pharmacokinetics (PPK) model. Summary statistics for these individual predicted PK parameters and exposures were stratified by dose. The PPK model analysis was based on combined PK data collected on days 1, 21, and 90.
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Timepoint [18]
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From first dose to up to 90 days after first dose
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Secondary outcome [19]
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Pharmacokinetic Parameter - Volume of the Central Compartment (VC)
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Assessment method [19]
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Pharmacokinetic Parameter - Volume of the Central Compartment (VC). VC is derived from plasma concentration versus time data. PK parameters were generated using a Population Pharmacokinetics (PPK) model. Summary statistics for these individual predicted PK parameters and exposures were stratified by dose. The PPK model analysis was based on combined PK data collected on days 1, 21, and 90.
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Timepoint [19]
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From first dose to up to 90 days after first dose
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Secondary outcome [20]
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Volume of Incident Infarcts (New DWI+ or DWI- Lesions) by Participant on Day 90 MRI
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Assessment method [20]
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Total volume of diffusion-weighted imaging (DWI) magnetic resonance imaging (MRI) infarcts on the DWI Sequence on day 90 MRI.
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Timepoint [20]
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At day 90
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Secondary outcome [21]
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Number of Incident Infarcts (New DWI+ or DWI- Lesions) by Participant on Day 90 MRI
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Assessment method [21]
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Number of diffusion-weighted imaging (DWI) magnetic resonance imaging (MRI) infarcts on the DWI Sequence on day 90 MRI.
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Timepoint [21]
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At day 90
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Eligibility
Key inclusion criteria
* Male and Female =40 years of age
* Acute Ischemic Stroke or Transient Ischemic Attack
* Intracranial or Extracranial Atherosclerotic Plaque proximal to the affected brain area
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Minimum age
40
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
* Predicted inability to swallow study medication
* Any condition that, in the opinion of the Investigator, contraindicates anticoagulant therapy or would have an unacceptable risk of bleeding
* Use of thrombolytic therapy or mechanical thrombectomy for treatment of index stroke
Other protocol defined inclusion/exclusion criteria could apply
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Study design
Purpose of the study
Prevention
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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
27/01/2019
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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
31/03/2022
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Sample size
Target
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Accrual to date
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Final
2366
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,TAS,VIC,WA
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Recruitment hospital [1]
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Local Institution - 0329 - Randwick
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Recruitment hospital [2]
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Local Institution - 0360 - Sydney
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Recruitment hospital [3]
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Local Institution - 0287 - Southport
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Recruitment hospital [4]
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Local Institution - 0399 - Adelaide
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Recruitment hospital [5]
0
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Local Institution - 0397 - Launceston
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Recruitment hospital [6]
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Local Institution - 0358 - Clayton
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Recruitment hospital [7]
0
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Local Institution - 0281 - Heidelberg
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Recruitment hospital [8]
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Local Institution - 0315 - Murdoch
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Recruitment postcode(s) [1]
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2031 - Randwick
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Recruitment postcode(s) [2]
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2170 - Sydney
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Recruitment postcode(s) [3]
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4215 - Southport
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Recruitment postcode(s) [4]
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5000 - Adelaide
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Recruitment postcode(s) [5]
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7250 - Launceston
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Recruitment postcode(s) [6]
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3168 - Clayton
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Recruitment postcode(s) [7]
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3084 - Heidelberg
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Recruitment postcode(s) [8]
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6150 - Murdoch
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Recruitment outside Australia
Country [1]
0
0
United States of America
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State/province [1]
0
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Alabama
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0
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United States of America
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State/province [2]
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California
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0
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United States of America
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State/province [3]
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Delaware
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0
United States of America
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Florida
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United States of America
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State/province [5]
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Georgia
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0
0
United States of America
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State/province [6]
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0
Hawaii
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Country [7]
0
0
United States of America
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State/province [7]
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Illinois
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Country [8]
0
0
United States of America
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State/province [8]
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Kentucky
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Country [9]
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United States of America
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State/province [9]
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Louisiana
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0
0
United States of America
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State/province [10]
0
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Maryland
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0
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United States of America
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State/province [11]
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Massachusetts
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United States of America
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State/province [12]
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Michigan
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United States of America
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Minnesota
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Missouri
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Montana
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New Jersey
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New York
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North Carolina
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Ohio
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Oklahoma
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Oregon
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Pennsylvania
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South Carolina
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United States of America
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Tennessee
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United States of America
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Texas
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Virginia
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0
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Wisconsin
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0
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Argentina
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Buenos Aires
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Argentina
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Santa Fe
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Austria
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State/province [30]
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Klagenfurt Am Woerthersee
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Austria
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State/province [31]
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St. Pölten
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Austria
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Vocklabruck
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Austria
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Wien
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0
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Belgium
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Antwerpen
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0
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Belgium
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0
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Brussels
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0
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Belgium
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Namur
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0
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Belgium
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Brasschaat
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0
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Belgium
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Bruges
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Belgium
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Bruxelles
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Belgium
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Gent
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Belgium
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Kortrijk
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Belgium
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Leuven
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Belgium
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Liege
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Brazil
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Ceara
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Brazil
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Minas Gerais
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0
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Brazil
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0
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Parana
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0
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Brazil
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0
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Rio Grande Do Sul
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0
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Brazil
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0
0
Santa Catarina
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0
0
Brazil
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0
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SAO Paulo
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0
0
Canada
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0
0
Alberta
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0
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Canada
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State/province [51]
0
0
British Columbia
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0
0
Canada
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State/province [52]
0
0
Ontario
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0
0
Canada
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0
0
Quebec
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0
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Chile
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0
0
Valparaiso
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0
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Chile
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State/province [55]
0
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Los Angeles
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0
0
Chile
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0
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Valdivia
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0
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Chile
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State/province [57]
0
0
Viña del Mar
Query!
Country [58]
0
0
China
Query!
State/province [58]
0
0
Beijing
Query!
Country [59]
0
0
China
Query!
State/province [59]
0
0
Guangdong
Query!
Country [60]
0
0
China
Query!
State/province [60]
0
0
Hainan
Query!
Country [61]
0
0
China
Query!
State/province [61]
0
0
Heilongjiang
Query!
Country [62]
0
0
China
Query!
State/province [62]
0
0
Henan
Query!
Country [63]
0
0
China
Query!
State/province [63]
0
0
Jiangsu
Query!
Country [64]
0
0
China
Query!
State/province [64]
0
0
Jilin
Query!
Country [65]
0
0
China
Query!
State/province [65]
0
0
Liaoning
Query!
Country [66]
0
0
China
Query!
State/province [66]
0
0
Shandong
Query!
Country [67]
0
0
China
Query!
State/province [67]
0
0
Zhejiang
Query!
Country [68]
0
0
Czechia
Query!
State/province [68]
0
0
Olomoucký Kraj
Query!
Country [69]
0
0
Czechia
Query!
State/province [69]
0
0
Vysocina
Query!
Country [70]
0
0
Czechia
Query!
State/province [70]
0
0
Brno
Query!
Country [71]
0
0
Czechia
Query!
State/province [71]
0
0
Ceske Budejovice
Query!
Country [72]
0
0
Czechia
Query!
State/province [72]
0
0
Ostrava
Query!
Country [73]
0
0
Czechia
Query!
State/province [73]
0
0
Praha 2
Query!
Country [74]
0
0
Denmark
Query!
State/province [74]
0
0
Capital
Query!
Country [75]
0
0
Denmark
Query!
State/province [75]
0
0
Aalborg
Query!
Country [76]
0
0
Denmark
Query!
State/province [76]
0
0
Aarhus N
Query!
Country [77]
0
0
Denmark
Query!
State/province [77]
0
0
Copenhagen
Query!
Country [78]
0
0
Denmark
Query!
State/province [78]
0
0
Glostrup
Query!
Country [79]
0
0
Finland
Query!
State/province [79]
0
0
Helsinki
Query!
Country [80]
0
0
Finland
Query!
State/province [80]
0
0
Lappeenranta
Query!
Country [81]
0
0
Finland
Query!
State/province [81]
0
0
Turku
Query!
Country [82]
0
0
France
Query!
State/province [82]
0
0
Hérault
Query!
Country [83]
0
0
France
Query!
State/province [83]
0
0
Nord
Query!
Country [84]
0
0
France
Query!
State/province [84]
0
0
Bordeaux
Query!
Country [85]
0
0
France
Query!
State/province [85]
0
0
Bourg-en-Bresse
Query!
Country [86]
0
0
France
Query!
State/province [86]
0
0
Brest
Query!
Country [87]
0
0
France
Query!
State/province [87]
0
0
Caen
Query!
Country [88]
0
0
France
Query!
State/province [88]
0
0
Créteil
Query!
Country [89]
0
0
France
Query!
State/province [89]
0
0
Limoges Cedex
Query!
Country [90]
0
0
France
Query!
State/province [90]
0
0
Marseille
Query!
Country [91]
0
0
France
Query!
State/province [91]
0
0
Nancy
Query!
Country [92]
0
0
France
Query!
State/province [92]
0
0
Nimes
Query!
Country [93]
0
0
France
Query!
State/province [93]
0
0
Paris
Query!
Country [94]
0
0
France
Query!
State/province [94]
0
0
Rouen Cedex
Query!
Country [95]
0
0
France
Query!
State/province [95]
0
0
Toulouse Cedex 9
Query!
Country [96]
0
0
Germany
Query!
State/province [96]
0
0
Baden-Württemberg
Query!
Country [97]
0
0
Germany
Query!
State/province [97]
0
0
Hessen
Query!
Country [98]
0
0
Germany
Query!
State/province [98]
0
0
Sachsen
Query!
Country [99]
0
0
Germany
Query!
State/province [99]
0
0
Schleswig-Holstein
Query!
Country [100]
0
0
Germany
Query!
State/province [100]
0
0
Altenburg
Query!
Country [101]
0
0
Germany
Query!
State/province [101]
0
0
Berlin
Query!
Country [102]
0
0
Germany
Query!
State/province [102]
0
0
Bielefeld
Query!
Country [103]
0
0
Germany
Query!
State/province [103]
0
0
Bonn
Query!
Country [104]
0
0
Germany
Query!
State/province [104]
0
0
Bremen
Query!
Country [105]
0
0
Germany
Query!
State/province [105]
0
0
Dresden
Query!
Country [106]
0
0
Germany
Query!
State/province [106]
0
0
Erlangen
Query!
Country [107]
0
0
Germany
Query!
State/province [107]
0
0
Essen
Query!
Country [108]
0
0
Germany
Query!
State/province [108]
0
0
Frankfurt am Main
Query!
Country [109]
0
0
Germany
Query!
State/province [109]
0
0
Gießen
Query!
Country [110]
0
0
Germany
Query!
State/province [110]
0
0
Hamburg
Query!
Country [111]
0
0
Germany
Query!
State/province [111]
0
0
Hannover
Query!
Country [112]
0
0
Germany
Query!
State/province [112]
0
0
Heidelberg
Query!
Country [113]
0
0
Germany
Query!
State/province [113]
0
0
Magdeburg
Query!
Country [114]
0
0
Germany
Query!
State/province [114]
0
0
Minden
Query!
Country [115]
0
0
Germany
Query!
State/province [115]
0
0
Münster
Query!
Country [116]
0
0
Germany
Query!
State/province [116]
0
0
Osnabruck
Query!
Country [117]
0
0
Germany
Query!
State/province [117]
0
0
Regensburg
Query!
Country [118]
0
0
Germany
Query!
State/province [118]
0
0
Sande
Query!
Country [119]
0
0
Germany
Query!
State/province [119]
0
0
Siegen
Query!
Country [120]
0
0
Germany
Query!
State/province [120]
0
0
Ulm
Query!
Country [121]
0
0
Greece
Query!
State/province [121]
0
0
Attiki
Query!
Country [122]
0
0
Greece
Query!
State/province [122]
0
0
Larisa
Query!
Country [123]
0
0
Greece
Query!
State/province [123]
0
0
Athens
Query!
Country [124]
0
0
Greece
Query!
State/province [124]
0
0
Crete
Query!
Country [125]
0
0
Greece
Query!
State/province [125]
0
0
Ioannina
Query!
Country [126]
0
0
Greece
Query!
State/province [126]
0
0
Larissa
Query!
Country [127]
0
0
Greece
Query!
State/province [127]
0
0
Loanniana
Query!
Country [128]
0
0
Greece
Query!
State/province [128]
0
0
Neo Faliro
Query!
Country [129]
0
0
Greece
Query!
State/province [129]
0
0
Patras
Query!
Country [130]
0
0
Greece
Query!
State/province [130]
0
0
Pireaus
Query!
Country [131]
0
0
Greece
Query!
State/province [131]
0
0
Thessaloniki
Query!
Country [132]
0
0
Hong Kong
Query!
State/province [132]
0
0
Hong Kong
Query!
Country [133]
0
0
Hungary
Query!
State/province [133]
0
0
BZ
Query!
Country [134]
0
0
Hungary
Query!
State/province [134]
0
0
Budapest
Query!
Country [135]
0
0
Hungary
Query!
State/province [135]
0
0
Debrecen
Query!
Country [136]
0
0
Hungary
Query!
State/province [136]
0
0
Gyor
Query!
Country [137]
0
0
Hungary
Query!
State/province [137]
0
0
Kistarcsa
Query!
Country [138]
0
0
Hungary
Query!
State/province [138]
0
0
Kisvárda
Query!
Country [139]
0
0
Hungary
Query!
State/province [139]
0
0
Nyíregyháza
Query!
Country [140]
0
0
Hungary
Query!
State/province [140]
0
0
Pecs
Query!
Country [141]
0
0
Hungary
Query!
State/province [141]
0
0
Szeged
Query!
Country [142]
0
0
Hungary
Query!
State/province [142]
0
0
Zalaegerszeg
Query!
Country [143]
0
0
Israel
Query!
State/province [143]
0
0
Beer-Sheva
Query!
Country [144]
0
0
Israel
Query!
State/province [144]
0
0
Haifa
Query!
Country [145]
0
0
Israel
Query!
State/province [145]
0
0
Jerusalem
Query!
Country [146]
0
0
Israel
Query!
State/province [146]
0
0
Nahariya
Query!
Country [147]
0
0
Israel
Query!
State/province [147]
0
0
Petah Tikva
Query!
Country [148]
0
0
Israel
Query!
State/province [148]
0
0
Ramat-Gan
Query!
Country [149]
0
0
Israel
Query!
State/province [149]
0
0
Tel Aviv
Query!
Country [150]
0
0
Italy
Query!
State/province [150]
0
0
Liguria
Query!
Country [151]
0
0
Italy
Query!
State/province [151]
0
0
Lombardia
Query!
Country [152]
0
0
Italy
Query!
State/province [152]
0
0
Marche
Query!
Country [153]
0
0
Italy
Query!
State/province [153]
0
0
Veneto
Query!
Country [154]
0
0
Italy
Query!
State/province [154]
0
0
Bologna
Query!
Country [155]
0
0
Italy
Query!
State/province [155]
0
0
Cagliari
Query!
Country [156]
0
0
Italy
Query!
State/province [156]
0
0
Milano
Query!
Country [157]
0
0
Italy
Query!
State/province [157]
0
0
Modena
Query!
Country [158]
0
0
Italy
Query!
State/province [158]
0
0
Perugia
Query!
Country [159]
0
0
Italy
Query!
State/province [159]
0
0
Roma
Query!
Country [160]
0
0
Italy
Query!
State/province [160]
0
0
Verona
Query!
Country [161]
0
0
Italy
Query!
State/province [161]
0
0
Vibo Valentia
Query!
Country [162]
0
0
Japan
Query!
State/province [162]
0
0
Aichi
Query!
Country [163]
0
0
Japan
Query!
State/province [163]
0
0
Chiba
Query!
Country [164]
0
0
Japan
Query!
State/province [164]
0
0
Fukuoka
Query!
Country [165]
0
0
Japan
Query!
State/province [165]
0
0
Fukushima
Query!
Country [166]
0
0
Japan
Query!
State/province [166]
0
0
Gifu
Query!
Country [167]
0
0
Japan
Query!
State/province [167]
0
0
Gunma
Query!
Country [168]
0
0
Japan
Query!
State/province [168]
0
0
Hiroshima
Query!
Country [169]
0
0
Japan
Query!
State/province [169]
0
0
Hyogo
Query!
Country [170]
0
0
Japan
Query!
State/province [170]
0
0
Ishikawa
Query!
Country [171]
0
0
Japan
Query!
State/province [171]
0
0
Kagoshima
Query!
Country [172]
0
0
Japan
Query!
State/province [172]
0
0
Kanagawa
Query!
Country [173]
0
0
Japan
Query!
State/province [173]
0
0
Miyagi
Query!
Country [174]
0
0
Japan
Query!
State/province [174]
0
0
Nagasaki
Query!
Country [175]
0
0
Japan
Query!
State/province [175]
0
0
Osaka
Query!
Country [176]
0
0
Japan
Query!
State/province [176]
0
0
Saitama
Query!
Country [177]
0
0
Japan
Query!
State/province [177]
0
0
Tochigi
Query!
Country [178]
0
0
Japan
Query!
State/province [178]
0
0
Tokyo
Query!
Country [179]
0
0
Japan
Query!
State/province [179]
0
0
Yamaguchi
Query!
Country [180]
0
0
Japan
Query!
State/province [180]
0
0
Kyoto
Query!
Country [181]
0
0
Japan
Query!
State/province [181]
0
0
Saga
Query!
Country [182]
0
0
Korea, Republic of
Query!
State/province [182]
0
0
Gyeonggido
Query!
Country [183]
0
0
Korea, Republic of
Query!
State/province [183]
0
0
Seoul Teugbyeolsi
Query!
Country [184]
0
0
Korea, Republic of
Query!
State/province [184]
0
0
Anyang
Query!
Country [185]
0
0
Korea, Republic of
Query!
State/province [185]
0
0
Busan
Query!
Country [186]
0
0
Korea, Republic of
Query!
State/province [186]
0
0
Daegu
Query!
Country [187]
0
0
Korea, Republic of
Query!
State/province [187]
0
0
Gwangju
Query!
Country [188]
0
0
Korea, Republic of
Query!
State/province [188]
0
0
Incheon
Query!
Country [189]
0
0
Korea, Republic of
Query!
State/province [189]
0
0
Seongnam-si
Query!
Country [190]
0
0
Korea, Republic of
Query!
State/province [190]
0
0
Seoul
Query!
Country [191]
0
0
Mexico
Query!
State/province [191]
0
0
Distrito Federal
Query!
Country [192]
0
0
Mexico
Query!
State/province [192]
0
0
Jalisco
Query!
Country [193]
0
0
Mexico
Query!
State/province [193]
0
0
Nuevo LEON
Query!
Country [194]
0
0
Mexico
Query!
State/province [194]
0
0
Sinaloa
Query!
Country [195]
0
0
Mexico
Query!
State/province [195]
0
0
Durango
Query!
Country [196]
0
0
Norway
Query!
State/province [196]
0
0
Bergen
Query!
Country [197]
0
0
Norway
Query!
State/province [197]
0
0
Grålum
Query!
Country [198]
0
0
Norway
Query!
State/province [198]
0
0
Kristiansand
Query!
Country [199]
0
0
Norway
Query!
State/province [199]
0
0
Lørenskog
Query!
Country [200]
0
0
Norway
Query!
State/province [200]
0
0
Oslo
Query!
Country [201]
0
0
Norway
Query!
State/province [201]
0
0
Stavanger
Query!
Country [202]
0
0
Poland
Query!
State/province [202]
0
0
Mazowieckie
Query!
Country [203]
0
0
Poland
Query!
State/province [203]
0
0
Bydgoszcz
Query!
Country [204]
0
0
Poland
Query!
State/province [204]
0
0
Chelm
Query!
Country [205]
0
0
Poland
Query!
State/province [205]
0
0
Gdansk
Query!
Country [206]
0
0
Poland
Query!
State/province [206]
0
0
Grodzisk Mazowieciki
Query!
Country [207]
0
0
Poland
Query!
State/province [207]
0
0
Katowice
Query!
Country [208]
0
0
Poland
Query!
State/province [208]
0
0
Konskie
Query!
Country [209]
0
0
Poland
Query!
State/province [209]
0
0
Lodz
Query!
Country [210]
0
0
Poland
Query!
State/province [210]
0
0
Olsztyn
Query!
Country [211]
0
0
Poland
Query!
State/province [211]
0
0
Sandomierz
Query!
Country [212]
0
0
Poland
Query!
State/province [212]
0
0
Skarzysko-Kamienna
Query!
Country [213]
0
0
Poland
Query!
State/province [213]
0
0
Walcz
Query!
Country [214]
0
0
Poland
Query!
State/province [214]
0
0
Warszawa
Query!
Country [215]
0
0
Poland
Query!
State/province [215]
0
0
Wejherowo
Query!
Country [216]
0
0
Russian Federation
Query!
State/province [216]
0
0
Barnaul
Query!
Country [217]
0
0
Russian Federation
Query!
State/province [217]
0
0
Kemerovo
Query!
Country [218]
0
0
Russian Federation
Query!
State/province [218]
0
0
Moscow
Query!
Country [219]
0
0
Russian Federation
Query!
State/province [219]
0
0
Novosibirsk
Query!
Country [220]
0
0
Russian Federation
Query!
State/province [220]
0
0
Smolensk
Query!
Country [221]
0
0
Russian Federation
Query!
State/province [221]
0
0
St. Petersburg
Query!
Country [222]
0
0
Russian Federation
Query!
State/province [222]
0
0
Yaroslavl
Query!
Country [223]
0
0
Spain
Query!
State/province [223]
0
0
Barcelona
Query!
Country [224]
0
0
Spain
Query!
State/province [224]
0
0
Castilla Y León
Query!
Country [225]
0
0
Spain
Query!
State/province [225]
0
0
A Coruna
Query!
Country [226]
0
0
Spain
Query!
State/province [226]
0
0
Albacete
Query!
Country [227]
0
0
Spain
Query!
State/province [227]
0
0
Badalona
Query!
Country [228]
0
0
Spain
Query!
State/province [228]
0
0
Córdoba
Query!
Country [229]
0
0
Spain
Query!
State/province [229]
0
0
Girona
Query!
Country [230]
0
0
Spain
Query!
State/province [230]
0
0
L'Hospitalet de Llobregat
Query!
Country [231]
0
0
Spain
Query!
State/province [231]
0
0
Lleida
Query!
Country [232]
0
0
Spain
Query!
State/province [232]
0
0
Madrid
Query!
Country [233]
0
0
Spain
Query!
State/province [233]
0
0
San Sebastian
Query!
Country [234]
0
0
Spain
Query!
State/province [234]
0
0
Santiago de Compostela
Query!
Country [235]
0
0
Spain
Query!
State/province [235]
0
0
Sevilla
Query!
Country [236]
0
0
Spain
Query!
State/province [236]
0
0
Tarragona
Query!
Country [237]
0
0
Spain
Query!
State/province [237]
0
0
Terrassa
Query!
Country [238]
0
0
Spain
Query!
State/province [238]
0
0
Valencia
Query!
Country [239]
0
0
Spain
Query!
State/province [239]
0
0
Valladolid
Query!
Country [240]
0
0
Spain
Query!
State/province [240]
0
0
Vigo
Query!
Country [241]
0
0
Sweden
Query!
State/province [241]
0
0
Skane Lan
Query!
Country [242]
0
0
Sweden
Query!
State/province [242]
0
0
Göteborg
Query!
Country [243]
0
0
Sweden
Query!
State/province [243]
0
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Hassleholm
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Sweden
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Umea
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Sweden
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Uppsala
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Switzerland
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Basel-Stadt (de)
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Switzerland
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Bern (de)
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Switzerland
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Aarau
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Switzerland
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Geneve
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Switzerland
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Lausanne
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Switzerland
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Zurich
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United Kingdom
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Kent
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United Kingdom
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Aberdeen
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United Kingdom
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Ashford
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United Kingdom
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Bath
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United Kingdom
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Chester
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United Kingdom
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Edinburgh
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United Kingdom
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Glasgow
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Lancashire
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United Kingdom
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London
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United Kingdom
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Luton
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United Kingdom
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Nottingham
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United Kingdom
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Salford
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United Kingdom
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Sheffield
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United Kingdom
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Staffordshire
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Bristol-Myers Squibb
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Address
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Other collaborator category [1]
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Commercial sector/industry
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Janssen, LP
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Ethics approval
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Summary
Brief summary
The purpose of this clinical study is to determine whether the addition of an oral Factor XIa Inhibitor to Aspirin and Clopidogrel is more effective than standard therapy in secondary stroke prevention.
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Trial website
https://clinicaltrials.gov/study/NCT03766581
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Public notes
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Contacts
Principal investigator
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Bristol-Myers Squibb
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Bristol-Myers Squibb
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No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
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Other Details
Attachment
Study protocol
Study Protocol and Statistical Analysis Plan
https://cdn.clinicaltrials.gov/large-docs/81/NCT03766581/Prot_SAP_000.pdf
Statistical analysis plan
Study Protocol and Statistical Analysis Plan
https://cdn.clinicaltrials.gov/large-docs/81/NCT03766581/Prot_SAP_000.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT03766581
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