CV004-007 Thrombosis Chamber Study
Research type
Research Study
Full 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
IRAS ID
174716
Contact name
David Newby
Contact email
Sponsor organisation
Bristol-Myers Squibb International Corporation
Eudract number
2014-004941-29
Duration of Study in the UK
0 years, 6 months, 1 days
Research summary
The purpose of this study is to test whether the administration of the study drug BMS-986120 in healthy volunteers will reduce thrombus (blood clot) formation in human blood vessels.
Blood carries oxygen around the body which the body needs to perform its daily biological functions. When a blood clot forms in blood vessels it causes a blockage of the blood flow. As a result, the oxygen supply to the brain can be blocked, resulting in a sudden condition known as a transient ischaemic attack (TIA) or more commonly known as a stroke. Every year in the US, nearly 800,000 people experience a stroke and many of these people will experience an additional stroke in the future. Aspirin is the standard of care for trying to prevent strokes from re-occurring. This study is investigating as to whether BMS-986120 can prevent the formation of blood clots and act as alternative treatment for the prevention of strokes.
Because this study cannot measure how well BMS-896120 works in preventing strokes in the actual body of healthy people (they do not have active blood clots or strokes), a special piece of equipment called a Badimon Thrombus Perfusion Chamber will be used. This chamber contains porcine (pig) blood vessels which have been adapted to mimic a blood clot using the blood from volunteers who have taken BMS-986120. By attaching the chamber by a tube to a vein in the volunteer’s arm, this allows blood to flow through the chamber. The study team can then measure the size of any blood clots that form (or not as the case may be) in the chamber and test how well the study drug BMS-986120 works. This study will recruit 40 healthy, eligible volunteers at one UK site and will be expected to stay one night in a research facility.REC name
Scotland A: Adults with Incapacity only
REC reference
15/SS/0053
Date of REC Opinion
11 May 2015
REC opinion
Further Information Favourable Opinion