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Sponsored by: |
The Medicines Company |
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Information provided by: | The Medicines Company |
ClinicalTrials.gov Identifier: | NCT00767507 |
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 |
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 |
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 |
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Meredith Todd | 973-647-6088 | meredith.todd@themedco.com |
Principal Investigator: | Eric Topol, MD | SCRIPPS |
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 |