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The purpose of this study is to determine whether BMS-986141 is effective in reducing the recurrence of stroke in people who recently had a stroke, or a transient ischemic attack (known as a TIA or "mini stroke") and are receiving acetylsalicylic acid (also known as aspirin or ASA) to treat the stroke or TIA.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BMS-986141 0.8mg | Experimental | BMS-986141 0.8mg orally (tablets) and Aspirin (ASA) 75 to 162 mg orally (tablets) |
|
| BMS-986141 4.8mg | Experimental | BMS-986141 4.8mg orally (tablets) and ASA 75 to 162 mg orally (tablets) |
|
| Placebo | Placebo Comparator | Placebo orally (tablets) and ASA 75 to 162 mg orally (tablets) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-986141 | Drug |
| ||
| Aspirin |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Composite of Symptomatic Ischemic Stroke by Day 28 and Unrecognized Brain Infarction Assessed by MRI at Day 28 | The incidence of a composite of symptomatic ischemic stroke by Day 28 and unrecognized brain infarction assessed by MRI at Day 28 was to be reported by arm in all treated participants. | 28 Days |
| Percentage of Participants With Composite of Adjudicated Major Bleeding and Adjudicated Clinically Relevant Non-major (CRNM) Bleeding During the Treatment Period | The percentage of participants with composite of major bleeding and CRNM bleeding was to be reported. Point estimates and 95% CIs for event rates were to be presented by treatment, together with point estimates and 95% CIs for the difference of event rates between each BMS-986141 arm and placebo. | Up to 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Major Adverse Cardiovascular Events (MACE) | MACE was defined as a composite of adjudicated recurrent stroke, myocardial infarction, or cardiovascular death. The percentage of treated participants experiencing these events at Day 90 was to be reported by arm. | 90 days |
| Percentage of Participants With Adjudicated Symptomatic Recurrent Stroke (Including Fatal and Non-fatal) |
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For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bristol Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Banner University Medical Ctr | Phoenix | Arizona | 85006 | United States | ||
| Hoag Memorial Hospital |
Not provided
| Label | URL |
|---|---|
| BMS Clinical Trial Patient Recruiting | View source |
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16 participants were enrolled; 15 were randomized; 14 were treated. 1 participant was not randomized because the interactive voice response system did not work at the time of enrollment
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Matching placebo was taken once daily. Administration was exactly the same as for BMS-986141 |
| FG001 | BMS-986141 0.8 mg | BMS-986141 0.8 mg QD for up to 28 days |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Treatment |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 19, 2015 | Mar 30, 2018 |
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|
| Placebo | Other |
|
The percentage of participants with adjudicated symptomatic recurrent stroke at Day 28 was to be reported by arm for all treated participants. |
| Day 28 |
| Percentage of Participants With Composite of Unrecognized Brain Infarction Assessed by MRI at Day 28 and MACE at Day 90 | The percentage of participants with unrecognized brain infarction at Day 28 and MACE at Day 90 was to be reported by arm for all treated participants. | Day 90 |
| Percentage of Participants Composite of Adjudicated Recurrent Ischemic Stroke, Myocardial Infarction, or Cardiovascular Death | The percentage of treated participants with composite of adjudicated recurrent ischemic stroke, myocardial infarction, or cardiovascular death was reported by arm. | Day 90 |
| Newport Beach |
| California |
| 92658 |
| United States |
| Local Institution | Newark | Delaware | 19718 | United States |
| University Of Florida | Gainesville | Florida | 32610 | United States |
| University Of Florida Hsc/Jacksonville | Jacksonville | Florida | 32209 | United States |
| Florida Hospital | Orlando | Florida | 32803 | United States |
| Intercoastal Medical Group | Sarasota | Florida | 34239 | United States |
| Presence Saint Joseph Medical Center | Joliet | Illinois | 64035 | United States |
| University Of Louisville | Louisville | Kentucky | 40202 | United States |
| Local Institution | Baltimore | Maryland | 21215 | United States |
| Tufts Medical Center | Boston | Massachusetts | 02111 | United States |
| Boston Medical Center | Boston | Massachusetts | 02118 | United States |
| St. Lukes Marion Bloch Neuroscience Institute | Kansas City | Missouri | 64111 | United States |
| Advanced Neurology Specialists | Great Falls | Montana | 59405 | United States |
| Local Institution | Omaha | Nebraska | 68105 | United States |
| JFK Medical Center | Edison | New Jersey | 08820-3947 | United States |
| Local Institution | Chapel Hill | North Carolina | 27599 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| Guilford Medical Associates, Pa | Greensboro | North Carolina | 27405 | United States |
| Providence Portland Med Ctr | Portland | Oregon | 97225 | United States |
| Providence St Vincent Medical Center | Portland | Oregon | 97225 | United States |
| Oregon Health Science Univ | Portland | Oregon | 97239 | United States |
| Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| York Hospital | York | Pennsylvania | 17403 | United States |
| Medical University Of South Carolina | Charleston | South Carolina | 29425 | United States |
| Local Institution | Memphis | Tennessee | 38103 | United States |
| West Virginia University | Morgantown | West Virginia | 26505 | United States |
| Local Institution | Nagoya | Aichi-ken | 4600001 | Japan |
| Local Institution | Sapporo | Hokkaido | 0608570 | Japan |
| Local Institution | Kobe | Hyōgo | 6500047 | Japan |
| Local Institution | Sendai | Miyagi | 982-8523 | Japan |
| Local Institution | Hidaka-shi | Saitama | 3501298 | Japan |
| Local Institution | Fukuoka | 810-0001 | Japan |
| FG002 | BMS-986141 4.8 mg | BMS-986141 4.8 mg QD for up to 28 days |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Follow-up |
|
|
All randomized participants
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Matching placebo was taken once daily. Administration was exactly the same as for BMS-986141 |
| BG001 | BMS-986141 0.8 mg | BMS-986141 0.8 mg QD for up to 28 days |
| BG002 | BMS-986141 4.8 mg | BMS-986141 4.8 mg QD for up to 28 days |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | All randomized participants | Mean | Standard Deviation | years |
| ||||||||||||||
| Sex: Female, Male | All randomized participants | Count of Participants | Participants |
| |||||||||||||||
| Ethnicity (NIH/OMB) | All randomized participants | Count of Participants | Participants |
| |||||||||||||||
| Race (NIH/OMB) | All randomized participants | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Composite of Symptomatic Ischemic Stroke by Day 28 and Unrecognized Brain Infarction Assessed by MRI at Day 28 | The incidence of a composite of symptomatic ischemic stroke by Day 28 and unrecognized brain infarction assessed by MRI at Day 28 was to be reported by arm in all treated participants. | Insufficient data available to perform analysis due to study termination | Posted | 28 Days |
|
| |||||||||||||||||||||||||
| Primary | Percentage of Participants With Composite of Adjudicated Major Bleeding and Adjudicated Clinically Relevant Non-major (CRNM) Bleeding During the Treatment Period | The percentage of participants with composite of major bleeding and CRNM bleeding was to be reported. Point estimates and 95% CIs for event rates were to be presented by treatment, together with point estimates and 95% CIs for the difference of event rates between each BMS-986141 arm and placebo. | Insufficient data available to perform analysis due to study termination | Posted | Up to 90 days |
|
| |||||||||||||||||||||||||
| Secondary | Percentage of Participants With Major Adverse Cardiovascular Events (MACE) | MACE was defined as a composite of adjudicated recurrent stroke, myocardial infarction, or cardiovascular death. The percentage of treated participants experiencing these events at Day 90 was to be reported by arm. | Insufficient data available to perform analysis due to study termination | Posted | 90 days |
|
| |||||||||||||||||||||||||
| Secondary | Percentage of Participants With Adjudicated Symptomatic Recurrent Stroke (Including Fatal and Non-fatal) | The percentage of participants with adjudicated symptomatic recurrent stroke at Day 28 was to be reported by arm for all treated participants. | Insufficient data available to perform analysis due to study termination | Posted | Day 28 |
|
| |||||||||||||||||||||||||
| Secondary | Percentage of Participants With Composite of Unrecognized Brain Infarction Assessed by MRI at Day 28 and MACE at Day 90 | The percentage of participants with unrecognized brain infarction at Day 28 and MACE at Day 90 was to be reported by arm for all treated participants. | Insufficient data available to perform analysis due to study termination | Posted | Day 90 |
|
| |||||||||||||||||||||||||
| Secondary | Percentage of Participants Composite of Adjudicated Recurrent Ischemic Stroke, Myocardial Infarction, or Cardiovascular Death | The percentage of treated participants with composite of adjudicated recurrent ischemic stroke, myocardial infarction, or cardiovascular death was reported by arm. | Insufficient data available to perform analysis due to study termination | Posted | Day 90 |
|
|
From first dose until 30 days following last dose (assessed up to March 2017, approximately 6 months)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Matching placebo was taken once daily. Administration was exactly the same as for BMS-986141 | 0 | 3 | 0 | 3 | 0 | 3 |
| EG001 | BMS-986141 0.8 mg | BMS-986141 0.8 mg QD for up to 28 days | 0 | 5 | 0 | 5 | 4 | 5 |
| EG002 | BMS-986141 4.8 mg | BMS-986141 4.8 mg QD for up to 28 days | 0 | 7 | 1 | 7 | 3 | 7 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Encephalopathy | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blood Potassium Increased | Investigations | MedDRA 19.1 | Systematic Assessment |
| |
| Tinea Pedis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Vaginal Discharge | Reproductive system and breast disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Vulvovaginal Pruritis | Reproductive system and breast disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Viral Upper Respiratory Tract Infection | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
| |
| Micturation Urgency | Renal and urinary disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Oedema Peripheral | General disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Muscle Spasms | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 19.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
|
Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bristol-Myers Squibb Study Director | Bristol-Myers Squibb | Please Email: | Clinical.Trials@bms.com |
| SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Jul 7, 2016 | Mar 30, 2018 | Prot_001.pdf |
| ID | Term |
|---|---|
| D013927 | Thrombosis |
| ID | Term |
|---|---|
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C000729678 | BMS-986141 |
| D001241 | Aspirin |
| ID | Term |
|---|---|
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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| Administrative Reason by Sponsor |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|