Maintenance of platelet inhiBition with cangreloR after dIscontinuation ofthienopyriDines in patients undergoing surGEry: The BRIDGE trial - BRIDGE

The Medicines Company0 sites220 target enrollmentNovember 25, 2009

Overview

No summary available.

Registry

who.int

Start Date

November 25, 2009

End Date

TBD

Last Updated

12 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•1\. Provide written informed consent before initiation of any study related procedures.
•2\. Be at least 18 years of age.
•3\. Anticipate non\-emergent coronary artery bypass graft (CABG) surgery, either onpump” or off\-pump,” no sooner than 48 hours from randomization but no longer than 7 days from randomization, with patient to remain hospitalized until planned CABG.
•4\. Have received a thienopyridine (at least 75 mg of clopidogrel 500 mg ticlopidine, or 10mg prasugrel) within 72 hours prior to enrollment in the study for either:
•1\. the treatment of an acute coronary syndrome, regardless of time from ACS, and/or
•2\. as long\-term preventative therapy following drug\-eluting or bare metal stent treatment.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1\.2 Adults (18\-64 years) yes
•F.1\.2\.1 Number of subjects for this age range

•1\. Confirmed of suspected pregnancy (if woman of child\-bearing potential) or lactating females
•2\. Cerebrovascular accident within one year
•3\. Intracranial neoplasm or history of intracranial surgery
•4\. History of bleeding diathesis
•5\. Thrombocytopenia (platelet count of less than 100,000/µL)
•6\. Known International Normalized Ratio (INR) greater than 1\.5 at screening.
•7\. Requirement for dialysis treatment (hemodialysis or peritoneal)
•8\. Estimated Glomeular filtration rate eGFR \<30 ml/min
•9\. Administration of abciximab within 24 hours of randomization or administration of
•eptifibitide or tirofiban within 12 hours of randomization.