Thrombosis
Conditions
Brief summary
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.
Interventions
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: * Male or female, age 18 or older * Must have had a very recent stroke or transient ischemic attack (mini stroke) that can be confirmed by the study doctor * Able to be assigned to a study group no later than 48 hours after the stroke occurred * Has an image of the brain that confirms that the stroke was not caused by hemorrhage or other reason that could explain symptoms
Exclusion criteria
* A suspicion by the study doctor that the transient ischemic attack or stroke was caused by a blood clot that formed in the heart; examples of this include history of an abnormal heart rhythm known as atrial fibrillation or a ventricular aneurysm or defect of the heart. * Any condition requiring treatment with an anticoagulant * History of intracranial hemorrhage (bleeding in the brain) * Gastrointestinal (stomach or intestinal) bleeding in the last 3 months that required treatment * Planned or anticipated invasive surgery or procedure during the study * Unable to tolerate MRI procedures.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Composite of Symptomatic Ischemic Stroke by Day 28 and Unrecognized Brain Infarction Assessed by MRI at Day 28 | 28 Days | 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. |
| Percentage of Participants With Composite of Adjudicated Major Bleeding and Adjudicated Clinically Relevant Non-major (CRNM) Bleeding During the Treatment Period | Up to 90 days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Major Adverse Cardiovascular Events (MACE) | 90 days | 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. |
| Percentage of Participants With Adjudicated Symptomatic Recurrent Stroke (Including Fatal and Non-fatal) | Day 28 | The percentage of participants with adjudicated symptomatic recurrent stroke at Day 28 was to be reported by arm for all treated participants. |
| Percentage of Participants With Composite of Unrecognized Brain Infarction Assessed by MRI at Day 28 and MACE at Day 90 | 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. |
| Percentage of Participants Composite of Adjudicated Recurrent Ischemic Stroke, Myocardial Infarction, or Cardiovascular Death | Day 90 | The percentage of treated participants with composite of adjudicated recurrent ischemic stroke, myocardial infarction, or cardiovascular death was reported by arm. |
Countries
Japan, United States
Participant flow
Pre-assignment details
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
Participants by arm
| Arm | Count |
|---|---|
| Placebo Matching placebo was taken once daily. Administration was exactly the same as for BMS-986141 | 3 |
| BMS-986141 0.8 mg BMS-986141 0.8 mg QD for up to 28 days | 5 |
| BMS-986141 4.8 mg BMS-986141 4.8 mg QD for up to 28 days | 7 |
| Total | 15 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Follow-up | Administrative Reason by Sponsor | 0 | 1 | 0 |
| Follow-up | Lost to Follow-up | 0 | 0 | 1 |
| Follow-up | Withdrawal by Subject | 1 | 0 | 0 |
| Treatment | Administrative Reason by Sponsor | 1 | 3 | 4 |
| Treatment | Adverse Event | 0 | 0 | 1 |
| Treatment | Randomized, not treated | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | Placebo | BMS-986141 0.8 mg | BMS-986141 4.8 mg | Total |
|---|---|---|---|---|
| Age, Continuous | 63.3 years STANDARD_DEVIATION 9.2 | 64.8 years STANDARD_DEVIATION 12.2 | 66.7 years STANDARD_DEVIATION 7.6 | 65.4 years STANDARD_DEVIATION 9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 3 Participants | 5 Participants | 7 Participants | 15 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 2 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 3 Participants | 3 Participants | 5 Participants | 11 Participants |
| Sex: Female, Male Female | 1 Participants | 1 Participants | 3 Participants | 5 Participants |
| Sex: Female, Male Male | 2 Participants | 4 Participants | 4 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 3 | 0 / 5 | 0 / 7 |
| other Total, other adverse events | 0 / 3 | 4 / 5 | 3 / 7 |
| serious Total, serious adverse events | 0 / 3 | 0 / 5 | 1 / 7 |
Outcome results
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.
Time frame: 28 Days
Population: Insufficient data available to perform analysis due to study termination
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.
Time frame: Up to 90 days
Population: Insufficient data available to perform analysis due to study termination
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.
Time frame: Day 90
Population: Insufficient data available to perform analysis due to study termination
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.
Time frame: Day 28
Population: Insufficient data available to perform analysis due to study termination
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.
Time frame: Day 90
Population: Insufficient data available to perform analysis due to study termination
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.
Time frame: 90 days
Population: Insufficient data available to perform analysis due to study termination