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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
  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
Acute Coronary Syndrome
 Drug: cangrelor
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 [ Time Frame: Hospital discharge ] [ Designated as safety issue: No ]

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

Enrollment: 210
Study Start Date: October 2008
Study Completion Date: July 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Cangrelor 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
Placebo Comparator: Placebo 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

  Eligibility

Ages Eligible for Study:   18 Years to 90 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

Locations
United States, California
Scripps Clinic / Scripps Green Hospital
La Jolla, California, United States, 92037
Sponsors and Collaborators
The Medicines Company
Investigators
Principal Investigator: Eric Topol, MD Scripps
  More Information

No publications provided by The Medicines Company

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: The Medicines Company
ClinicalTrials.gov Identifier: NCT00767507     History of Changes
Other Study ID Numbers: TMC-CAN-08-02
Study First Received: October 6, 2008
Last Updated: January 18, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Acute Coronary Syndrome
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Angina Pectoris
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms
 Cangrelor
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 21, 2013