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Maintenance of Platelet Inhibition With Cangrelor (Bridge)

Primary Purpose

Acute Coronary Syndrome (ACS)

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
cangrelor
Placebo
Sponsored by
The Medicines Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Coronary Syndrome (ACS)

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Scripps Clinic / Scripps Green Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Cangrelor

Placebo

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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

Stage II: Analysis of Platelet Reactivity (ITT Population) / Patients With Platelet Reactivity < 240 PRU
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
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
Patients With Blood Product Transfusions up to 7 Days After Surgery or Discharge, Whichever Was Sooner

Full Information

First Posted
October 6, 2008
Last Updated
February 21, 2014
Sponsor
The Medicines Company
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1. Study Identification

Unique Protocol Identification Number
NCT00767507
Brief Title
Maintenance of Platelet Inhibition With Cangrelor
Acronym
Bridge
Official Title
BRIDGE: Maintenance of Platelet inihiBition With cangRelor After dIscontinuation of ThienopyriDines in Patients Undergoing surGEry
Study Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
July 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Medicines Company

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Coronary Syndrome (ACS)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
221 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cangrelor
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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 Type
Drug
Intervention Name(s)
cangrelor
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo IV infusion administered in the same fashion as the active study drug in order to maintain the blind in the study.
Primary Outcome Measure Information:
Title
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.
Description
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).
Time Frame
During study drug infusion up to 1-6 hours prior to surgery
Title
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.
Description
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.
Time Frame
During study drug infusion up to 1-6 hours prior to surgery
Secondary Outcome Measure Information:
Title
Stage II: Analysis of Platelet Reactivity (ITT Population) / Patients With Platelet Reactivity < 240 PRU
Description
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
Time Frame
baseline until just prior to surgery (post infusion)
Title
Incidence of Excessive Coronary Artery Bypass Graft (CABG)-Related Bleeding
Description
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
Time Frame
Randomization through Hospital discharge
Title
Non-CABG (Preoperative) Bleeding - Protocol-defined GUSTO Severe/Life-threatening, Moderate and Mild
Time Frame
Randomization until start of CABG surgery
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric Topol, MD
Organizational Affiliation
Scripps
Official's Role
Principal Investigator
Facility Information:
Facility Name
Scripps Clinic / Scripps Green Hospital
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
22253393
Citation
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. doi: 10.1001/jama.2011.2002.
Results Reference
derived

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Maintenance of Platelet Inhibition With Cangrelor

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