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Oral Factor XIa Inhibitor for the Prevention of New Ischemic Stroke in Patients Receiving Aspirin and Clopidogrel Following Acute Ischemic Stroke or Transient Ischemic Attack (TIA)

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ClinicalTrials.gov Identifier: NCT03766581
Recruitment Status : Not yet recruiting
First Posted : December 6, 2018
Last Update Posted : December 6, 2018
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. The safety of this treatment will also be studied.

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Dose ranging study using RAR (Response Adaptive Randomization) design
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: A Global, Phase 2, Randomized, Double-Blind, Placebo-Controlled, Response-Adaptive 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)
Estimated Study Start Date : December 31, 2018
Estimated Primary Completion Date : May 31, 2021
Estimated Study Completion Date : August 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Active Comparator
100 mg Aspirin + 75 mg Clopidogrel
Drug: Clopidogrel
Oral administration

Drug: Aspirin
Oral administration

Experimental: BMS-986177 A
25 mg BMS-986177 QD (daily) + 100 mg Aspirin + 75 mg Clopidogrel
Drug: BMS-986177
Oral administration

Other: BMS-986177 Placebo
Oral Administration

Drug: Clopidogrel
Oral administration

Drug: Aspirin
Oral administration

Experimental: BMS-986177 B
25 mg BMS-986177 BID (twice daily) + 100 mg Aspirin + 75 mg Clopidogrel
Drug: BMS-986177
Oral administration

Other: BMS-986177 Placebo
Oral Administration

Drug: Clopidogrel
Oral administration

Drug: Aspirin
Oral administration

Experimental: BMS-986177 C
50 mg BMS-986177 QD + 100 mg Aspirin + 75 mg Clopidogrel
Drug: BMS-986177
Oral administration

Other: BMS-986177 Placebo
Oral Administration

Drug: Clopidogrel
Oral administration

Drug: Aspirin
Oral administration

Experimental: BMS-986177 D
50 mg BMS-986177 BID + 100 mg Aspirin + 75 mg Clopidogrel
Drug: BMS-986177
Oral administration

Other: BMS-986177 Placebo
Oral Administration

Drug: Clopidogrel
Oral administration

Drug: Aspirin
Oral administration

Experimental: BMS-986177 E
100 mg BMS-986177 QD + 100 mg Aspirin + 75 mg Clopidogrel
Drug: BMS-986177
Oral administration

Other: BMS-986177 Placebo
Oral Administration

Drug: Clopidogrel
Oral administration

Drug: Aspirin
Oral administration

Experimental: BMS-986177 F
100 mg BMS-986177 BID + 100 mg Aspirin + 75 mg Clopidogrel
Drug: BMS-986177
Oral administration

Other: BMS-986177 Placebo
Oral Administration

Drug: Clopidogrel
Oral administration

Drug: Aspirin
Oral administration

Experimental: BMS-986177 G
200 mg BMS-986177 QD + 100 mg Aspirin + 75 mg Clopidogrel
Drug: BMS-986177
Oral administration

Other: BMS-986177 Placebo
Oral Administration

Drug: Clopidogrel
Oral administration

Drug: Aspirin
Oral administration

Experimental: BMS-986177 H
200 mg BMS-986177 BID + 100 mg Aspirin + 75 mg Clopidogrel
Drug: BMS-986177
Oral administration

Other: BMS-986177 Placebo
Oral Administration

Drug: Clopidogrel
Oral administration

Drug: Aspirin
Oral administration




Primary Outcome Measures :
  1. Composite of new ischemic stroke and new covert brain infarction (FLAIR+DWI) during the treatment period [ Time Frame: 90 days ]

Secondary Outcome Measures :
  1. Event rate based on bleeding according to Bleeding Academic Research Consortium (BARC) Type 3 and 5 [ Time Frame: 90 days ]
  2. Event rate based on BARC, ISTH and PLATO-defined criteria [ Time Frame: 90 days ]
  3. 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 ]
  4. Percent change from baseline in aPTT and Factor XI clotting activity during treatment [ Time Frame: 90 days ]
  5. Percent change from baseline in Factor XI [ Time Frame: 90 days ]
  6. Location of new FLAIR + DWI lesions [ Time Frame: 90 days ]
    Detected by MRI

  7. Number of new FLAIR + DWI lesions [ Time Frame: 90 days ]
    Detected by MRI

  8. Volume of new FLAIR + DWI lesions [ Time Frame: 90 days ]
    Detected by MRI

  9. 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

  10. 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

  11. 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

  12. 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

  13. Estimated clearance (CL) [ Time Frame: 90 days ]
    CL will be described using descriptive statistics

  14. Volume of distribution (Vd) [ Time Frame: 90 days ]
    Vd will be described using descriptive statistics

  15. Event rates for new ischemic, non-fatal stroke, non-fatal myocardial infarction during the treatment period [ Time Frame: 90 days ]
  16. Event rates for all cause-death during the treatment period [ Time Frame: 90 days ]
  17. Incidence of AE's and SAE's [ Time Frame: 90 days ]
    BMS-986177

  18. Distribution of clinical characteristics [ Time Frame: 90 days ]
    BMS-986177 clinical characteristics will be summarized using descriptive statistics



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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 acute ischemic stroke event

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

Additional Information:
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 6, 2018
Last Verified: December 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Stroke
Ischemia
Cerebral Infarction
Ischemic Attack, Transient
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Brain Infarction
Brain Ischemia
Aspirin
Ticlopidine
Clopidogrel
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