Maintenance of Platelet Inhibition With Cangrelor (Bridge)
|ClinicalTrials.gov Identifier: NCT00767507|
Recruitment Status : Completed
First Posted : October 7, 2008
Results First Posted : April 4, 2014
Last Update Posted : April 4, 2014
|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|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||BRIDGE: Maintenance of Platelet inihiBition With cangRelor After dIscontinuation of ThienopyriDines in Patients Undergoing surGEry|
|Study Start Date :||October 2008|
|Actual Primary Completion Date :||June 2011|
|Actual Study Completion Date :||July 2011|
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.
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.
Placebo IV infusion administered in the same fashion as the active study drug in order to maintain the blind in the study.
- 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).
- 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.
- 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
- 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
- Non-CABG (Preoperative) Bleeding - Protocol-defined GUSTO Severe/Life-threatening, Moderate and Mild [ Time Frame: Randomization until start of CABG surgery ]
- 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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00767507
|United States, California|
|Scripps Clinic / Scripps Green Hospital|
|La Jolla, California, United States, 92037|
|Principal Investigator:||Eric Topol, MD||Scripps|