Maintenance of Platelet Inhibition With Cangrelor (Bridge)

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

The Medicines Company

ClinicalTrials.gov Identifier:

NCT00767507

First received: October 6, 2008

Last updated: January 18, 2012

Last verified: January 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

October 6, 2008

Last Updated Date

January 18, 2012

Start Date ^ICMJE

October 2008

Primary Completion Date

June 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Platelet Inhibition [ Time Frame: Hospital discharge ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Platelet Inhibition [ Designated as safety issue: No ]

Change History

Complete list of historical versions of study NCT00767507 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Absence of excessive CABG related bleeding [ Time Frame: Hospital discharge ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

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

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Maintenance of Platelet Inhibition With Cangrelor

Official Title ^ICMJE

BRIDGE: Maintenance of Platelet inihiBition With cangRelor After dIscontinuation of ThienopyriDines in Patients Undergoing surGEry

Brief Summary

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Acute Coronary Syndrome

Intervention ^ICMJE

Drug: cangrelor

Cangrelor/matching placebo: continuous IV infusion of 0.75µg/kg/min for a minimum of 48 hours and a maximum of 7 days

Study Arm (s)

Active Comparator: Cangrelor
Intervention: Drug: cangrelor
Placebo Comparator: Placebo
Intervention: Drug: cangrelor

Publications *

Angiolillo DJ, Firstenberg MS, Price MJ, Tummala PE, Hutyra M, Welsby IJ, Voeltz MD, Chandna H, Ramaiah C, Brtko M, Cannon L, Dyke C, Liu T, Montalescot G, Manoukian SV, Prats J, Topol EJ; BRIDGE Investigators. Bridging antiplatelet therapy with cangrelor in patients undergoing cardiac surgery: a randomized controlled trial. JAMA. 2012 Jan 18;307(3):265-74.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

210

Completion Date

July 2011

Primary Completion Date

June 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 90 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00767507

Other Study ID Numbers ^ICMJE

TMC-CAN-08-02

Has Data Monitoring Committee

Yes

Responsible Party

The Medicines Company

Study Sponsor ^ICMJE

The Medicines Company

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Eric Topol, MD

Scripps

Information Provided By

The Medicines Company

Verification Date

January 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top