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CompletedNCT02439190Updated Sep 8, 2016

CV004-007 Thrombosis Chamber Study

A Phase 1 interventional study of BMS-986120 and Aspirin in Thrombosis, sponsored by Bristol-Myers Squibb. Completed at 1 site in United Kingdom. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-09-08.

Sponsored by Bristol-Myers Squibb · Phase 1 and Interventional

Phase
Phase 1
Study type
Interventional
Enrollment
42
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this study is to determine whether BMS-986120, aspirin, or aspirin and clopidogrel decrease blood clotting.

02

Conditions studied

  • Thrombosis

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03

In context

Thrombosis

1,528 studies on the registry are indexed under Thrombosis; 240 are open to participants now.

This study's enrollment of 42 is below the median of 107 across 866 interventional studies indexed under Thrombosis.

Browse Thrombosis studies →

Lead sponsor

Bristol-Myers Squibb is the lead sponsor of 1,562 studies on the registry; 118 are open to participants now.

Of its 435 completed or terminated interventional studies of FDA-regulated products, 227 (52%) have results posted.

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Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion criteria

Inclusion Criteria:

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Phase 1
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
42 participants (actual)

Study arms

  • Active comparator
    Treatment A: BMS-986120

    BMS-986120 on specified days

    Drug: BMS-986120

  • Active comparator
    Treatment B: Aspirin and Clopidogrel

    Aspirin and Clopidogrel on specified days

    Drug: Aspirin · Drug: Clopidogrel

Interventions

06

What researchers measure

Primary outcomes

  1. Change from baseline in thrombus area (post-treatment with BMS-986120 vs. pre-treatment)

    Time frame: 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

    Time frame: 2 days

07

Study locations

1 site
  • Local Institution
    Edinburgh, Scotland EH16 4SA, United Kingdom
08

References and documents

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 ↗
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Sep 2015, a primary completion of Mar 2016 and a completion of Mar 2016. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 2, 2015
First posted
May 8, 2015
Start
Sep 2015
Primary completionActual
Mar 2016
CompletionActual
Mar 2016
Last update
Sep 8, 2016
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 8, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02439190
Lead sponsor
Bristol-Myers Squibb
Responsible party
Sponsor
First posted
May 8, 2015
Start date
Sep 2015
Primary completion
Mar 2016
Completion
Mar 2016
Last update
Sep 8, 2016

Study contacts

Bristol-Myers Squibb
study director · Bristol-Myers Squibb

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2016. You cannot join it, but the record below documents what was studied.

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Studies of the drugs tested here: Aspirin · Clopidogrel

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