ThrombosisPhase 1NCT02439190
CV004-007 Thrombosis Chamber Study
A Phase 1 study testing BMS-986120, Aspirin and Clopidogrel in people with Thrombosis, run by Bristol-Myers Squibb at 1 site in United Kingdom.
Trial summary
The purpose of this study is to determine whether BMS-986120, aspirin, or aspirin and clopidogrel decrease blood clotting. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Thrombosis
- What is being tested?
- BMS-986120, Aspirin and Clopidogrel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2015to Mar 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs and clinical laboratory determinations
- Body Mass Index (BMI) of 18 to 32 kg/m2 inclusive. BMI = weight (kg)/ [height (m)]2
- Females who are not of childbearing potential (i.e., who are post-menopausal or surgically sterile) and men ages 18 to 65, inclusive
- Azoospermic males and women who are not of child-bearing potential (i.e. are postmenopausal or surgically sterile; see section 3.3.3 for the definition of WOCBP) are exempt from contraceptive requirements. However, women must still undergo pregnancy testing as described in this section
Who cannot join
- Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG or clinical laboratory determinations beyond what is consistent with the target population
- Any condition that could affect drug absorption
- Other protocol-defined exclusion criteria could apply
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single Dose Study to Evaluate the Effect of BMS-986120 on Thrombus Formation in an Ex Vivo Thrombosis Chamber Model in Healthy Subjects
The purpose of this study is to determine whether BMS-986120, aspirin, or aspirin and clopidogrel decrease blood clotting.
- Conditions
- Thrombosis
- Being tested
- BMS-986120, Aspirin, Clopidogrel
- Medical subject headings
- Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-986120Drug
AspirinDrug
ClopidogrelDrug
| Study group | Role | What they receive |
|---|---|---|
| Treatment A: BMS-986120 | Active comparator | BMS-986120 on specified days Receives: Drug: BMS-986120 |
| Treatment B: Aspirin and Clopidogrel | Active comparator | Aspirin and Clopidogrel on specified days Receives: Drug: Aspirin; Drug: Clopidogrel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in thrombus area (post-treatment with BMS-986120 vs. pre-treatment)
Measured: 2 days
Secondary outcomes (1)
Safety and tolerability of BMS 986120 or aspirin administered with and without clopidogrel based on adverse events,clinical laboratory tests, physical examinations and vital signs per the collection schedule
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2015 (estimated)
- Study startSep 2015
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 1
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 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
- NCT02439190
- Sponsor's protocol ID
- CV004-007
- Status last verified
- Apr 2016
- First submitted
- 2 Apr 2015
- Last updated
- 8 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Wilson SJ, Ismat FA, Wang Z, Cerra M, Narayan H, Raftis J, Gray TJ, Connell S, Garonzik S, Ma X, Yang J, Newby DE. PAR4 (Protease-Activated Receptor 4) Antagonism With BMS-986120 Inhibits Human Ex Vivo Thrombus Formation. Arterioscler Thromb Vasc Biol. 2018 Feb;38(2):448-456. doi: 10.1161/ATVBAHA.117.310104. Epub 2017 Dec 21.
PubMed 29269513
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Dose Study to Evaluate the Effect of BMS-986120 on Thrombus Formation in an Ex Vivo Thrombosis Chamber Model in Healthy Subjects
- ClinicalTrials.gov ID
- NCT02439190
- Acronym / sponsor ID
- CV004-007
- Conditions
- Thrombosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- Sep 2015
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 8 May 2015 (estimated)
- Results
- Not posted in the source record
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-986120, aspirin, or aspirin and clopidogrel decrease blood clotting.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment A: BMS-986120 | Active comparator | Drug: BMS-986120BMS-986120 on specified days |
| Treatment B: Aspirin and Clopidogrel | Active comparator | Drug: Aspirin, Drug: ClopidogrelAspirin and Clopidogrel on specified days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs and clinical laboratory determinations
- Body Mass Index (BMI) of 18 to 32 kg/m2 inclusive. BMI = weight (kg)/ [height (m)]2
- Females who are not of childbearing potential (i.e., who are post-menopausal or surgically sterile) and men ages 18 to 65, inclusive
- Azoospermic males and women who are not of child-bearing potential (i.e. are postmenopausal or surgically sterile; see section 3.3.3 for the definition of WOCBP) are exempt from contraceptive requirements. However, women must still undergo pregnancy testing as described in this section
Key exclusion criteria (3 listed)
- Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG or clinical laboratory determinations beyond what is consistent with the target population
- Any condition that could affect drug absorption
- Other protocol-defined exclusion criteria could apply
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-986120 | Drug | Treatment A: BMS-986120 |
| Aspirin | Drug | Treatment B: Aspirin and Clopidogrel |
| Clopidogrel | Drug | Treatment B: Aspirin and Clopidogrel |
Primary outcome
Change from baseline in thrombus area (post-treatment with BMS-986120 vs. pre-treatment)
Time frame: 2 days
1 secondary outcome
Safety and tolerability of BMS 986120 or aspirin administered with and without clopidogrel based on adverse events,clinical laboratory tests, physical examinations and vital signs per the collection schedule
Time frame: 2 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2016.
- Derived from this study: PubMed 29269513Wilson SJ, Ismat FA, Wang Z, Cerra M, Narayan H, Raftis J, Gray TJ, Connell S, Garonzik S, Ma X, Yang J, Newby DE. PAR4 (Protease-Activated Receptor 4) Antagonism With BMS-986120 Inhibits Human Ex Vivo Thrombus Formation. Arterioscler Thromb Vasc Biol. 2018 Feb;38(2):448-456. doi: 10.1161/ATVBAHA.117.310104. Epub 2017 Dec 21.
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BMS-986120, Aspirin and Clopidogrel in people with Thrombosis, run by Bristol-Myers Squibb at 1 site in United Kingdom.
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 3 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 8 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change from baseline in thrombus area (post-treatment with BMS-986120 vs. pre-treatment) (time frame: 2 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02439190, which also lists 1 linked publication.
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 8 Sep 2016.