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Maintenance of Platelet Inhibition With Cangrelor (Bridge)

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ClinicalTrials.gov Identifier: NCT00767507
Recruitment Status : Completed
First Posted : October 7, 2008
Results First Posted : April 4, 2014
Last Update Posted : April 4, 2014
Sponsor:
Information provided by (Responsible Party):
The Medicines Company

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.

Condition or disease Intervention/treatment Phase
Acute Coronary Syndrome (ACS) Drug: cangrelor Other: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 221 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: BRIDGE: Maintenance of Platelet inihiBition With cangRelor After dIscontinuation of ThienopyriDines in Patients Undergoing surGEry
Study Start Date : October 2008
Primary Completion Date : June 2011
Study Completion Date : July 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Cangrelor
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Cangrelor
Cangrelor was administered as a continuous IV infusion of 0.75µg/kg/min for a minimum of 48 hours and a maximum of 7 days.
Drug: cangrelor
Placebo Comparator: Placebo
A placebo infusion was administered as a continuous IV infusion of 0.75µg/kg/min for a minimum of 48 hours and a maximum of 7 days, to maintain the blind.
Other: Placebo
Placebo IV infusion administered in the same fashion as the active study drug in order to maintain the blind in the study.



Primary Outcome Measures :
  1. Stage I: Percentage of Patient Samples That Maintained Platelet Inhibition Levels of Greater Than or Equal to 60% as Reported by the VerifyNow P2Y12 Point of Care Assay. [ Time Frame: During study drug infusion up to 1-6 hours prior to surgery ]
    Endpoint was selected as an approximation of the antiplatelet effect expected to be maintained if oral P2Y12 inhibitors had not been discontinued (60% inhibition of platelets).

  2. Stage II: The Percentage of Patients That Maintained Platelet Reaction Units (PRU) < 240, as Determined by the VerifyNow P2Y12 Point of Care Assay, Measured During Study Drug Infusion Pre-surgery. [ Time Frame: During study drug infusion up to 1-6 hours prior to surgery ]

    This endpoint was selected as it is considered by consensus of the Working Group on Platelet Reactivity to be the threshold for the level of platelet inhibition required to maintain a low risk of coronary thrombosis and cardiac ischemic events.

    Patients had multiple samples and all "on-infusion" samples had to be <240 PRU to meet the endpoint.



Secondary Outcome Measures :
  1. Stage II: Analysis of Platelet Reactivity (ITT Population) / Patients With Platelet Reactivity < 240 PRU [ Time Frame: baseline until just prior to surgery (post infusion) ]

    This endpoint analyzed the percent of patients with platelet reactivity < 240 PRU at the following timepoints:

    • Baseline - Prior to study drug infusion (washout period from oral P2Y12 inhibition)
    • Last sample during infusion
    • Following discontinuation of study drug infusion

  2. Incidence of Excessive Coronary Artery Bypass Graft (CABG)-Related Bleeding [ Time Frame: Randomization through Hospital discharge ]
    Defined as the occurrence of surgical re-exploration, 24-hour chest tube output of >1.5 liters (L), and/or packed red blood cell transfusions > 4 units

  3. Non-CABG (Preoperative) Bleeding - Protocol-defined GUSTO Severe/Life-threatening, Moderate and Mild [ Time Frame: Randomization until start of CABG surgery ]
  4. Patients With Blood Product Transfusions up to 7 Days After Surgery or Discharge, Whichever Was Sooner [ Time Frame: Through 7 days or hospital discharge, whichever was sooner ]


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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: October 7, 2008    Key Record Dates
Results First Posted: April 4, 2014
Last Update Posted: April 4, 2014
Last Verified: February 2014

Additional relevant MeSH terms:
Acute Coronary Syndrome
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Cangrelor
Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs