ThrombosisPhase 2NCT02671461
Safety and Efficacy Study of a Protease Activated Receptor-4 Antagonist Being Tested to Reduce the Chances of Having Additional Strokes or "Mini Strokes"
A Phase 2 study testing BMS-986141 and Aspirin in people with Thrombosis, run by Bristol-Myers Squibb at 33 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thrombosis
- What is being tested?
- BMS-986141 and Aspirin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 33 sitesin 2 countries
- Study dates
- 25 Apr 2016to 31 Mar 2017
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
33 sites in 2 countries.
33 sites in 2 countries
United States27 sites
Local Institution
Baltimore, Maryland, 21215
Tufts Medical Center
Boston, Massachusetts, 02111
Boston Medical Center
Boston, Massachusetts, 02118
Local Institution
Chapel Hill, North Carolina, 27599
Medical University Of South Carolina
Charleston, South Carolina, 29425
Duke University Medical Center
Durham, North Carolina, 27710
JFK Medical Center
Edison, New Jersey, 08820-3947
University Of Florida
Gainesville, Florida, 32610
Advanced Neurology Specialists
Great Falls, Montana, 59405
Guilford Medical Associates, Pa
Greensboro, North Carolina, 27405
University Of Florida Hsc/Jacksonville
Jacksonville, Florida, 32209
Presence Saint Joseph Medical Center
Joliet, Illinois, 64035
St. Lukes Marion Bloch Neuroscience Institute
Kansas City, Missouri, 64111
University Of Louisville
Louisville, Kentucky, 40202
Local Institution
Memphis, Tennessee, 38103
West Virginia University
Morgantown, West Virginia, 26505
Local Institution
Newark, Delaware, 19718
Hoag Memorial Hospital
Newport Beach, California, 92658
Local Institution
Omaha, Nebraska, 68105
Florida Hospital
Orlando, Florida, 32803
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Banner University Medical Ctr
Phoenix, Arizona, 85006
Providence Portland Med Ctr
Portland, Oregon, 97225
Providence St Vincent Medical Center
Portland, Oregon, 97225
Oregon Health Science Univ
Portland, Oregon, 97239
Intercoastal Medical Group
Sarasota, Florida, 34239
York Hospital
York, Pennsylvania, 17403
Japan6 sites
Local Institution
Fukuoka, 810-0001
Local Institution
Hidaka-shi, Saitama, 3501298
Local Institution
Kobe, Hyōgo, 6500047
Local Institution
Nagoya, Aichi-ken, 4600001
Local Institution
Sapporo, Hokkaido, 0608570
Local Institution
Sendai, Miyagi, 982-8523
About this study
Official title: A Phase 2, Placebo Controlled, Randomized, Double-Blind, Parallel-Arm Study to Evaluate Efficacy and Safety of BMS- 986141 For the Prevention of Recurrent Brain Infarction in Subjects Receiving Acetylsalicylic Acid (ASA) Following Acute Ischemic Stroke or Transient Ischemic Attack
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.
- Conditions
- Thrombosis
- Being tested
- BMS-986141, Aspirin, Placebo
- Medical subject headings
- Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-986141Drug
AspirinDrug
PlaceboOther
| Study group | Role | What they receive |
|---|---|---|
| BMS-986141 0.8mg | Experimental | BMS-986141 0.8mg orally (tablets) and Aspirin (ASA) 75 to 162 mg orally (tablets) Receives: Drug: BMS-986141; Drug: Aspirin |
| BMS-986141 4.8mg | Experimental | BMS-986141 4.8mg orally (tablets) and ASA 75 to 162 mg orally (tablets) Receives: Drug: BMS-986141; Drug: Aspirin |
| Placebo | Placebo comparator | Placebo orally (tablets) and ASA 75 to 162 mg orally (tablets) Receives: Drug: Aspirin; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Up to 90 days
Secondary outcomes (4)
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.
Measured: 90 days
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.
Measured: 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.
Measured: 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.
Measured: Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2016 (estimated)
- Study start25 Apr 2016
- Primary completion31 Mar 2017
- Study completion31 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for ThrombosisStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02671461
- Sponsor's protocol ID
- CV006-004
- Status last verified
- Dec 2018
- First submitted
- 29 Jan 2016
- Last updated
- 14 Dec 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Placebo Controlled, Randomized, Double-Blind, Parallel-Arm Study to Evaluate Efficacy and Safety of BMS- 986141 For the Prevention of Recurrent Brain Infarction in Subjects Receiving Acetylsalicylic Acid (ASA) Following Acute Ischemic Stroke or Transient Ischemic Attack
- ClinicalTrials.gov ID
- NCT02671461
- Acronym / sponsor ID
- CV006-004
- Conditions
- Thrombosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 25 Apr 2016 (actual)
- Primary completion
- 31 Mar 2017 (actual)
- Study completion
- 31 Mar 2017 (actual)
- First posted
- 2 Feb 2016 (estimated)
- Results
- Posted 12 Jun 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| BMS-986141 0.8mg | Experimental | Drug: BMS-986141, Drug: AspirinBMS-986141 0.8mg orally (tablets) and Aspirin (ASA) 75 to 162 mg orally (tablets) |
| BMS-986141 4.8mg | Experimental | Drug: BMS-986141, Drug: AspirinBMS-986141 4.8mg orally (tablets) and ASA 75 to 162 mg orally (tablets) |
| Placebo | Placebo comparator | Drug: Aspirin, Other: PlaceboPlacebo orally (tablets) and ASA 75 to 162 mg orally (tablets) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BMS-986141 | Drug | BMS-986141 0.8mg, BMS-986141 4.8mg |
| Aspirin | Drug | BMS-986141 0.8mg, BMS-986141 4.8mg, Placebo |
| Placebo | Other | Placebo |
Primary outcome
Number of Participants With Composite of Symptomatic Ischemic Stroke by Day 28 and Unrecognized Brain Infarction Assessed by MRI at Day 28
Time frame: 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
Time frame: 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.
4 secondary outcomes
Percentage of Participants With Major Adverse Cardiovascular Events (MACE)
Time frame: 90 days
Percentage of Participants With Adjudicated Symptomatic Recurrent Stroke (Including Fatal and Non-fatal)
Time frame: Day 28
Percentage of Participants With Composite of Unrecognized Brain Infarction Assessed by MRI at Day 28 and MACE at Day 90
Time frame: Day 90
Percentage of Participants Composite of Adjudicated Recurrent Ischemic Stroke, Myocardial Infarction, or Cardiovascular Death
Time frame: Day 90
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bristol Myers Squibb study director
Bristol-Myers Squibb
33 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BMS-986141 and Aspirin in people with Thrombosis, run by Bristol-Myers Squibb at 33 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 33 sites in United States, Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Jun 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Composite of Symptomatic Ischemic Stroke by Day 28 and Unrecognized Brain Infarction Assessed by MRI at Day 28 (time frame: 28 Days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2018.