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: February 21, 2014
Last verified: February 2014

October 6, 2008
February 21, 2014
October 2008
June 2011   (final data collection date for primary outcome measure)
  • 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 ] [ Designated as safety issue: No ]
    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).
  • 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 ] [ Designated as safety issue: No ]

    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.

Platelet Inhibition [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00767507 on ClinicalTrials.gov Archive Site
  • Stage II: Analysis of Platelet Reactivity (ITT Population) / Patients With Platelet Reactivity < 240 PRU [ Time Frame: baseline until just prior to surgery (post infusion) ] [ Designated as safety issue: No ]

    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
  • Incidence of Excessive Coronary Artery Bypass Graft (CABG)-Related Bleeding [ Time Frame: Randomization through Hospital discharge ] [ Designated as safety issue: Yes ]
    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
  • Non-CABG (Preoperative) Bleeding - Protocol-defined GUSTO Severe/Life-threatening, Moderate and Mild [ Time Frame: Randomization until start of CABG surgery ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
Surgical re-exploration 24 Hour CT out put [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Maintenance of Platelet Inhibition With Cangrelor
BRIDGE: Maintenance of Platelet inihiBition With cangRelor After dIscontinuation of ThienopyriDines in Patients Undergoing surGEry

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Acute Coronary Syndrome (ACS)
  • Drug: cangrelor
  • Other: Placebo
    Placebo IV infusion administered in the same fashion as the active study drug in order to maintain the blind in the study.
  • 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.
    Intervention: 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.
    Intervention: Other: Placebo
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.
 
Completed
221
July 2011
June 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00767507
TMC-CAN-08-02
Yes
The Medicines Company
The Medicines Company
Not Provided
Principal Investigator: Eric Topol, MD Scripps
The Medicines Company
February 2014

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