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A Study on BMS-986177 for the Prevention of a Stroke in Patients Receiving Aspirin and Clopidogrel (AXIOMATIC-SSP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03766581
Recruitment Status : Recruiting
First Posted : December 6, 2018
Last Update Posted : July 31, 2020
Sponsor:
Collaborator:
Janssen, LP
Information provided by (Responsible Party):
Bristol-Myers Squibb

Tracking Information
First Submitted Date  ICMJE November 13, 2018
First Posted Date  ICMJE December 6, 2018
Last Update Posted Date July 31, 2020
Actual Study Start Date  ICMJE November 30, 2018
Estimated Primary Completion Date March 31, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 30, 2019)
Composite of new ischemic stroke during the treatment period and new covert brain infarction (FLAIR + DWI) detected by MRI [ Time Frame: Up to 90 days ]
Original Primary Outcome Measures  ICMJE
 (submitted: December 5, 2018)
Composite of new ischemic stroke and new covert brain infarction (FLAIR+DWI) during the treatment period [ Time Frame: 90 days ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 30, 2019)
  • Event rate based on bleeding according to Bleeding Academic Research Consortium (BARC) Type 3 and 5 [ Time Frame: Up to 90 days ]
  • Event rate based on BARC, International Society on Thrombosis and Hemostasis (ISTH) and Platelet Inhibition and Patient Outcomes (PLATO)-defined criteria [ Time Frame: Up to 90 days ]
  • Rate of the composite of new ischemic stroke and new covert brain infarction during the treatment period [ Time Frame: Up to 90 days ]
  • Location of new FLAIR + DWI lesions [ Time Frame: Up to 90 days ]
  • Number of new FLAIR + DWI lesions [ Time Frame: Up to 90 days ]
  • Volume of new FLAIR + DWI lesions [ Time Frame: Up to 90 days ]
  • Event rates for new ischemic, non-fatal stroke, non-fatal myocardial infarction and all-cause death during the treatment period [ Time Frame: Up to 90 days ]
  • Assessment of Stroke Severity by the National Institutes of Health Stroke Scale (NIHSS) [ Time Frame: Day 21 and Day 90 ]
  • Assessment of Neurological function by the modified Rankin Scale (mRS) [ Time Frame: Day 21 and Day 90 ]
  • Assessment of Cognitive function as by the Montreal Cognitive Assessment (MoCA) [ Time Frame: Day 21 and Day 90 ]
  • Incidence of Adverse Events (AEs) [ Time Frame: First dose up to 97 days ]
  • Incidence of Serious Adverse Events (SAEs) [ Time Frame: First dose up to 97 days ]
  • Change from Baseline in Heart Rate [ Time Frame: Up to 90 Days ]
  • Change from Baseline in Blood Pressure [ Time Frame: Up to 90 Days ]
  • Change from Baseline in Respiratory Rate [ Time Frame: Up to 90 Days ]
  • Change from Baseline in Body Temperature [ Time Frame: Up to 90 Days ]
  • Incidence of Abnormalities in Physical Examination [ Time Frame: Up to 90 days ]
  • Incidence of Electrocardiogram (ECG) abnormalities [ Time Frame: Up to 90 Days ]
  • Change from baseline in Clinical Laboratory Value of blood [ Time Frame: Up to 90 Days ]
  • Change from baseline in Clinical Laboratory Value of Urine [ Time Frame: Up to 90 Days ]
  • Change from baseline in Clinical Laboratory Value of Blood Serum [ Time Frame: Up to 90 Days ]
  • Change from Baseline in Estimated Clearance (CL) [ Time Frame: Up to 90 Days ]
  • Change from Baseline in Volume of Distribution (Vd) [ Time Frame: Up to 90 days ]
  • Percent change from baseline in aPTT clotting activity during treatment [ Time Frame: Up to 90 Days ]
  • Percent change from baseline in Factor XI clotting activity during treatment [ Time Frame: Up to 90 Days ]
Original Secondary Outcome Measures  ICMJE
 (submitted: December 5, 2018)
  • Event rate based on bleeding according to Bleeding Academic Research Consortium (BARC) Type 3 and 5 [ Time Frame: 90 days ]
  • Event rate based on BARC, ISTH and PLATO-defined criteria [ Time Frame: 90 days ]
  • Rate of the composite of new ischemic stroke and new covert brain infarction (FLAIR + DWI) during the treatment period detected by MRI at 90 days [ Time Frame: 90 days ]
  • Percent change from baseline in aPTT and Factor XI clotting activity during treatment [ Time Frame: 90 days ]
  • Percent change from baseline in Factor XI [ Time Frame: 90 days ]
  • Location of new FLAIR + DWI lesions [ Time Frame: 90 days ]
    Detected by MRI
  • Number of new FLAIR + DWI lesions [ Time Frame: 90 days ]
    Detected by MRI
  • Volume of new FLAIR + DWI lesions [ Time Frame: 90 days ]
    Detected by MRI
  • National Institute of Health Stroke Scale (NIHSS) on Days 21 and 90 and at the time of a new stroke event [ Time Frame: 21 and 90 days ]
    BMS-986177
  • Modified Rankin Scale (mRS) on Days 21 and 90 and at the time of a new stroke event [ Time Frame: 21 and 90 days ]
    BMS-986177
  • Montreal Cognitive Assessment (MoCA) on Days 21 and 90 and at the time of a new stroke event [ Time Frame: 21 and 90 days ]
    BMS-986177
  • Digit Symbol Substitution Test (DSST) on Days 21 and 90 and at the time of a new stroke event [ Time Frame: 21 and 90 days ]
    BMS-986177
  • Estimated clearance (CL) [ Time Frame: 90 days ]
    CL will be described using descriptive statistics
  • Volume of distribution (Vd) [ Time Frame: 90 days ]
    Vd will be described using descriptive statistics
  • Event rates for new ischemic, non-fatal stroke, non-fatal myocardial infarction during the treatment period [ Time Frame: 90 days ]
  • Event rates for all cause-death during the treatment period [ Time Frame: 90 days ]
  • Incidence of AE's and SAE's [ Time Frame: 90 days ]
    BMS-986177
  • Distribution of clinical characteristics [ Time Frame: 90 days ]
    BMS-986177 clinical characteristics will be summarized using descriptive statistics
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study on BMS-986177 for the Prevention of a Stroke in Patients Receiving Aspirin and Clopidogrel
Official Title  ICMJE 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)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Acute Ischemic Stroke
  • Transient Ischemic Attack (TIA)
Intervention  ICMJE
  • Drug: BMS-986177
    Oral administration
  • Other: Placebo
    Oral Administration
  • Drug: Clopidogrel
    Oral administration
  • Drug: Aspirin
    Oral administration
Study Arms  ICMJE
  • Placebo Comparator: BMS-986177 Placebo
    Specified Dose on Specified Days
    Interventions:
    • Other: Placebo
    • Drug: Clopidogrel
    • Drug: Aspirin
  • Experimental: Dose 1: BMS-986177 + Aspirin + Clopidogrel
    Specified Dose on Specified Days
    Interventions:
    • Drug: BMS-986177
    • Drug: Clopidogrel
    • Drug: Aspirin
  • Experimental: Dose 2: BMS-986177 + Aspirin + Clopidogrel
    Specified Dose on Specified Days
    Interventions:
    • Drug: BMS-986177
    • Drug: Clopidogrel
    • Drug: Aspirin
  • Experimental: Dose 3: BMS-986177 + Aspirin + Clopidogrel
    Specified Dose on Specified Days
    Interventions:
    • Drug: BMS-986177
    • Drug: Clopidogrel
    • Drug: Aspirin
  • Experimental: Dose 4: BMS-986177 + Aspirin + Clopidogrel
    Specified Dose on Specified Days
    Interventions:
    • Drug: BMS-986177
    • Drug: Clopidogrel
    • Drug: Aspirin
  • Experimental: Dose 5: BMS-986177 + Aspirin + Clopidogrel
    Specified Dose on Specified Days
    Interventions:
    • Drug: BMS-986177
    • Drug: Clopidogrel
    • Drug: Aspirin
  • Experimental: Dose 6: BMS-986177 + Aspirin + Clopidogrel
    Specified Dose on Specified Days
    Interventions:
    • Drug: BMS-986177
    • Drug: Clopidogrel
    • Drug: Aspirin
  • Experimental: Dose 7: BMS-986177 + Aspirin + Clopidogrel
    Specified Dose on Specified Days
    Interventions:
    • Drug: BMS-986177
    • Drug: Clopidogrel
    • Drug: Aspirin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 30, 2019)
2350
Original Estimated Enrollment  ICMJE
 (submitted: December 5, 2018)
3000
Estimated Study Completion Date  ICMJE March 31, 2022
Estimated Primary Completion Date March 31, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

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

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information please email Clinical.Trials@bms.com
Contact: First line of the email MUST contain NCT # and Site #
Listed Location Countries  ICMJE Argentina,   Australia,   Austria,   Belgium,   Brazil,   Canada,   Chile,   China,   Czechia,   Denmark,   Finland,   France,   Germany,   Greece,   Hungary,   Israel,   Italy,   Japan,   Korea, Republic of,   Mexico,   Norway,   Poland,   Russian Federation,   Spain,   Sweden,   Switzerland,   United Kingdom,   United States
Removed Location Countries Hong Kong
 
Administrative Information
NCT Number  ICMJE NCT03766581
Other Study ID Numbers  ICMJE CV010-031
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bristol-Myers Squibb
Study Sponsor  ICMJE Bristol-Myers Squibb
Collaborators  ICMJE Janssen, LP
Investigators  ICMJE
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
PRS Account Bristol-Myers Squibb
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP