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

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ClinicalTrials.gov Identifier: NCT03766581
Recruitment Status : Recruiting
First Posted : December 6, 2018
Last Update Posted : December 4, 2019
Sponsor:
Collaborator:
Janssen, LP
Information provided by (Responsible Party):
Bristol-Myers Squibb

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.

Condition or disease Intervention/treatment Phase
Acute Ischemic Stroke Transient Ischemic Attack (TIA) Drug: BMS-986177 Other: Placebo Drug: Clopidogrel Drug: Aspirin Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2350 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official 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)
Actual Study Start Date : November 30, 2018
Estimated Primary Completion Date : April 30, 2021
Estimated Study Completion Date : April 30, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: BMS-986177 Placebo
Specified Dose on Specified Days
Other: Placebo
Oral Administration

Drug: Clopidogrel
Oral administration

Drug: Aspirin
Oral administration

Experimental: Dose 1: BMS-986177 + Aspirin + Clopidogrel
Specified Dose on Specified Days
Drug: BMS-986177
Oral administration

Drug: Clopidogrel
Oral administration

Drug: Aspirin
Oral administration

Experimental: Dose 2: BMS-986177 + Aspirin + Clopidogrel
Specified Dose on Specified Days
Drug: BMS-986177
Oral administration

Drug: Clopidogrel
Oral administration

Drug: Aspirin
Oral administration

Experimental: Dose 3: BMS-986177 + Aspirin + Clopidogrel
Specified Dose on Specified Days
Drug: BMS-986177
Oral administration

Drug: Clopidogrel
Oral administration

Drug: Aspirin
Oral administration

Experimental: Dose 4: BMS-986177 + Aspirin + Clopidogrel
Specified Dose on Specified Days
Drug: BMS-986177
Oral administration

Drug: Clopidogrel
Oral administration

Drug: Aspirin
Oral administration

Experimental: Dose 5: BMS-986177 + Aspirin + Clopidogrel
Specified Dose on Specified Days
Drug: BMS-986177
Oral administration

Drug: Clopidogrel
Oral administration

Drug: Aspirin
Oral administration

Experimental: Dose 6: BMS-986177 + Aspirin + Clopidogrel
Specified Dose on Specified Days
Drug: BMS-986177
Oral administration

Drug: Clopidogrel
Oral administration

Drug: Aspirin
Oral administration

Experimental: Dose 7: BMS-986177 + Aspirin + Clopidogrel
Specified Dose on Specified Days
Drug: BMS-986177
Oral administration

Drug: Clopidogrel
Oral administration

Drug: Aspirin
Oral administration




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Event rate based on bleeding according to Bleeding Academic Research Consortium (BARC) Type 3 and 5 [ Time Frame: Up to 90 days ]
  2. 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 ]
  3. Rate of the composite of new ischemic stroke and new covert brain infarction during the treatment period [ Time Frame: Up to 90 days ]
  4. Location of new FLAIR + DWI lesions [ Time Frame: Up to 90 days ]
  5. Number of new FLAIR + DWI lesions [ Time Frame: Up to 90 days ]
  6. Volume of new FLAIR + DWI lesions [ Time Frame: Up to 90 days ]
  7. 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 ]
  8. Assessment of Stroke Severity by the National Institutes of Health Stroke Scale (NIHSS) [ Time Frame: Day 21 and Day 90 ]
  9. Assessment of Neurological function by the modified Rankin Scale (mRS) [ Time Frame: Day 21 and Day 90 ]
  10. Assessment of Cognitive function as by the Montreal Cognitive Assessment (MoCA) [ Time Frame: Day 21 and Day 90 ]
  11. Incidence of Adverse Events (AEs) [ Time Frame: First dose up to 97 days ]
  12. Incidence of Serious Adverse Events (SAEs) [ Time Frame: First dose up to 97 days ]
  13. Change from Baseline in Heart Rate [ Time Frame: Up to 90 Days ]
  14. Change from Baseline in Blood Pressure [ Time Frame: Up to 90 Days ]
  15. Change from Baseline in Respiratory Rate [ Time Frame: Up to 90 Days ]
  16. Change from Baseline in Body Temperature [ Time Frame: Up to 90 Days ]
  17. Incidence of Abnormalities in Physical Examination [ Time Frame: Up to 90 days ]
  18. Incidence of Electrocardiogram (ECG) abnormalities [ Time Frame: Up to 90 Days ]
  19. Change from baseline in Clinical Laboratory Value of blood [ Time Frame: Up to 90 Days ]
  20. Change from baseline in Clinical Laboratory Value of Urine [ Time Frame: Up to 90 Days ]
  21. Change from baseline in Clinical Laboratory Value of Blood Serum [ Time Frame: Up to 90 Days ]
  22. Change from Baseline in Estimated Clearance (CL) [ Time Frame: Up to 90 Days ]
  23. Change from Baseline in Volume of Distribution (Vd) [ Time Frame: Up to 90 days ]
  24. Percent change from baseline in aPTT clotting activity during treatment [ Time Frame: Up to 90 Days ]
  25. Percent change from baseline in Factor XI clotting activity during treatment [ Time Frame: Up to 90 Days ]


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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03766581


Contacts
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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 #

  Show 313 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
Janssen, LP
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT03766581     History of Changes
Other Study ID Numbers: CV010-031
First Posted: December 6, 2018    Key Record Dates
Last Update Posted: December 4, 2019
Last Verified: December 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Ischemic Attack, Transient
Ischemia
Brain Ischemia
Aspirin
Clopidogrel
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists