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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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
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)
Secondary ID [1] 0 0
CV010-031
Universal Trial Number (UTN)
Trial acronym
AXIOMATIC-SSP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Ischemic Stroke 0 0
Transient Ischemic Attack (TIA) 0 0
Condition category
Condition code
Stroke 0 0 0 0
Haemorrhagic
Stroke 0 0 0 0
Ischaemic
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
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
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
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
Timepoint [1] 0 0
From randomization to up to 90 days after randomization
Secondary outcome [1] 0 0
Percent of Participants With Major Bleeding According to BARC Type 3 and 5
Timepoint [1] 0 0
From first dose to up to 107 days after first dose
Secondary outcome [2] 0 0
Number of Participants With Bleeding Based on BARC Types 1-5
Timepoint [2] 0 0
From first dose to up to 107 days after first dose
Secondary outcome [3] 0 0
Number of Participants With Bleeding Based on ISTH-Defined Criteria
Timepoint [3] 0 0
From first dose to up to 107 days after first dose
Secondary outcome [4] 0 0
Number of Participants With Bleeding Based on PLATO-Defined Criteria
Timepoint [4] 0 0
From first dose to up to 107 days after first dose
Secondary outcome [5] 0 0
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
Timepoint [5] 0 0
From randomization to up to 90 days after randomization
Secondary outcome [6] 0 0
Composite of Percent of Participants With New Ischemic Stroke, MI and All Cause Death
Timepoint [6] 0 0
From randomization to up to 90 days after randomization
Secondary outcome [7] 0 0
National Institutes of Health Stroke Scale (NIHSS)
Timepoint [7] 0 0
At baseline, on Days 21 and 90, and at the time of a new stroke event
Secondary outcome [8] 0 0
Modified Rankin Scale (mRS)
Timepoint [8] 0 0
At baseline, on Days 21 and 90, and at the time of a new stroke event
Secondary outcome [9] 0 0
Montreal Cognitive Assessment (MoCA)
Timepoint [9] 0 0
At baseline, on Days 21 and 90, and at the time of a new stroke event
Secondary outcome [10] 0 0
Digit Symbol Substitution Test (DSST)
Timepoint [10] 0 0
At baseline, on Days 21 and 90, and at the time of a new stroke event
Secondary outcome [11] 0 0
Number of Participants With Adverse Events (AEs)
Timepoint [11] 0 0
From first dose to 2 days after last dose of study therapy (up to approximately 107 days)
Secondary outcome [12] 0 0
Number of Participants With Clinically Significant Vital Sign Abnormalities
Timepoint [12] 0 0
From first dose to up to 90 days after first dose
Secondary outcome [13] 0 0
Number of Participants With Clinically Significant Physical Examination Abnormalities
Timepoint [13] 0 0
From first dose to up to 90 days after first dose
Secondary outcome [14] 0 0
Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities
Timepoint [14] 0 0
From first dose to up to 90 days after first dose
Secondary outcome [15] 0 0
Number of Participants With Clinically Significant Laboratory Abnormalities - Liver
Timepoint [15] 0 0
From first dose to up to approximately 38 months
Secondary outcome [16] 0 0
Percent Change From Baseline in aPTT Activity
Timepoint [16] 0 0
Baseline and day 90
Secondary outcome [17] 0 0
Percent Change From Baseline in Factor XI Clotting Activity
Timepoint [17] 0 0
Baseline and day 90
Secondary outcome [18] 0 0
Pharmacokinetic Parameter - Estimated Clearance (CL)
Timepoint [18] 0 0
From first dose to up to 90 days after first dose
Secondary outcome [19] 0 0
Pharmacokinetic Parameter - Volume of the Central Compartment (VC)
Timepoint [19] 0 0
From first dose to up to 90 days after first dose
Secondary outcome [20] 0 0
Volume of Incident Infarcts (New DWI+ or DWI- Lesions) by Participant on Day 90 MRI
Timepoint [20] 0 0
At day 90
Secondary outcome [21] 0 0
Number of Incident Infarcts (New DWI+ or DWI- Lesions) by Participant on Day 90 MRI
Timepoint [21] 0 0
At day 90

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
Minimum age
40 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Prevention
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
27/01/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
31/03/2022
Sample size
Target
Accrual to date
Final
2366
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,TAS,VIC,WA
Recruitment hospital [1] 0 0
Local Institution - 0329 - Randwick
Recruitment hospital [2] 0 0
Local Institution - 0360 - Sydney
Recruitment hospital [3] 0 0
Local Institution - 0287 - Southport
Recruitment hospital [4] 0 0
Local Institution - 0399 - Adelaide
Recruitment hospital [5] 0 0
Local Institution - 0397 - Launceston
Recruitment hospital [6] 0 0
Local Institution - 0358 - Clayton
Recruitment hospital [7] 0 0
Local Institution - 0281 - Heidelberg
Recruitment hospital [8] 0 0
Local Institution - 0315 - Murdoch
Recruitment postcode(s) [1] 0 0
2031 - Randwick
Recruitment postcode(s) [2] 0 0
2170 - Sydney
Recruitment postcode(s) [3] 0 0
4215 - Southport
Recruitment postcode(s) [4] 0 0
5000 - Adelaide
Recruitment postcode(s) [5] 0 0
7250 - Launceston
Recruitment postcode(s) [6] 0 0
3168 - Clayton
Recruitment postcode(s) [7] 0 0
3084 - Heidelberg
Recruitment postcode(s) [8] 0 0
6150 - Murdoch
Recruitment outside Australia
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Klagenfurt Am Woerthersee
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St. Pölten
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Vocklabruck
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Baden-Württemberg
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Hessen
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Sachsen
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Ulm
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Attiki
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Crete
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Larissa
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Loanniana
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Neo Faliro
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Patras
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Pireaus
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Greece
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Gyor
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Kistarcsa
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Pecs
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Szeged
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Zalaegerszeg
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Israel
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Beer-Sheva
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Israel
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Haifa
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Israel
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Israel
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Petah Tikva
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Israel
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Ramat-Gan
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Israel
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Tel Aviv
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Italy
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Marche
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Milano
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Modena
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Perugia
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Roma
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Verona
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Japan
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Aichi
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Chiba
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Fukuoka
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Gunma
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Hyogo
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Ishikawa
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Kagoshima
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Kanagawa
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Miyagi
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Nagasaki
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Osaka
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Saitama
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Tochigi
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Tokyo
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Yamaguchi
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Japan
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Kyoto
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Japan
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Saga
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Korea, Republic of
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Gyeonggido
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Korea, Republic of
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Seoul Teugbyeolsi
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Korea, Republic of
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Anyang
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Korea, Republic of
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Busan
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Korea, Republic of
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Daegu
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Korea, Republic of
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Gwangju
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Korea, Republic of
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Incheon
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Korea, Republic of
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Seongnam-si
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Korea, Republic of
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Seoul
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Mexico
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Bristol-Myers Squibb
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Janssen, LP
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT03766581
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bristol-Myers Squibb
Address 0 0
Bristol-Myers Squibb
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/NCT03766581