Maintenance of Platelet Inhibition With Cangrelor - Full Text View

Maintenance of Platelet Inhibition With Cangrelor (Bridge)

This study is not yet open for participant recruitment.

Verified by The Medicines Company, October 2008

Sponsored by:	The Medicines Company
Information provided by:	The Medicines Company
ClinicalTrials.gov Identifier:	NCT00767507

Purpose

The purpose of this study is to demonstrate that patients receiving cangrelor infusion before coronary artery bypass grafting have an acceptable safety profile and can undergo surgery without excessive bleeding peri-operatively.

Condition	Intervention	Phase
ACS CABG	Procedure: CABG	Phase II

Drug Information available for: Cangrelor

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
Official Title:	BRIDGE: Maintenance of Platelet inihiBition With cangRelor After dIscontinuation of ThienopyriDines in Patients Undergoing surGEry

Further study details as provided by The Medicines Company:

Primary Outcome Measures:

Platelet Inhibition [ Designated as safety issue: No ]

Secondary Outcome Measures:

Surgical re-exploration 24 Hour CT out put [ Designated as safety issue: No ]

Estimated Enrollment:	220
Study Start Date:	October 2008
Estimated Study Completion Date:	October 2009
Estimated Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Cangrelor: Active Comparator	Procedure: CABG
Placebo: Placebo Comparator	Procedure: CABG

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Written informed consent 18 Years of Age non emergent coronary bypass graft surgery Received a thienopyridine within 48 hours prior to enrollment

Exclusion Criteria:

Confirmed or suspected pregnancy Cerebrovascular accident within one yar Intracranial neoplasm History of bleeding diathesis Thrombocytopenia

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00767507

Contacts

Contact: Meredith Todd

973-647-6088

meredith.todd@themedco.com

Sponsors and Collaborators

The Medicines Company

Investigators

Principal Investigator:

Eric Topol, MD

SCRIPPS

More Information

Responsible Party:	The Medicines Company ( Meredith Todd, Director Clinical Operations )
Study ID Numbers:	TMC-CAN-08-02
Study First Received:	October 6, 2008
Last Updated:	October 6, 2008
ClinicalTrials.gov Identifier:	NCT00767507
Health Authority:	United States: Food and Drug Administration

ClinicalTrials.gov processed this record on January 16, 2009