A Clinical Trial Comparing Cangrelor to Clopidogrel Standard Therapy in Subjects Who Require Percutaneous Coronary Intervention (PCI) (CHAMPION PHOENIX) (CHAMPION)
|Atherosclerosis Percutaneous Coronary Intervention Acute Coronary Syndrome||Drug: cangrelor P2Y12 (platelet) inhibitor Drug: Clopidogrel - 300 or 600 mg (study arm) Drug: Clopidogrel 600 mg post cangrelor||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Clinical Trial Comparing Cangrelor to Clopidogrel Standard of Care Therapy in Subjects Who Require Percutaneous Coronary Intervention (CHAMPION PHOENIX)|
- The Composite Incidence of All-cause Mortality, Myocardial Infarction (MI), Ischemia-driven Revascularization (IDR) and Stent Thrombosis (ST) [ Time Frame: 48 hours after randomization ]Clinical Events Committee (CEC)-adjudicated results (modified intent-to-treat [mITT] population)
- Individual Incidence of Stent Thrombosis (ST), Death, Myocardial Infarction (MI) and Ischemia-driven Revascularization (IDR) [ Time Frame: 48 hours after randomization ]CEC-adjudicated results (mITT population)
- Incidence of Major/Minor Non-coronary Artery Bypass Graft (CABG)-Related Hemorrhage by Clinical Relevant Criteria - GUSTO Severe/Life-threatening, Moderate and Mild [ Time Frame: 48 hours after randomization ]GUSTO = Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Coronary Arteries trial
|Study Start Date:||September 2010|
|Study Completion Date:||December 2012|
|Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
Cangrelor was administered as a 30 µg/kg bolus followed by a 4.0 µg/kg/min cangrelor IV infusion for a minimum of 2 hours or until conclusion of the index procedure, whichever is longer. At the discretion of the treating physician, the infusion could be continued for a total duration of 4 hours.
Following the discontinuation of the cangrelor infusion, 600mg of clopidogrel was administered.
Drug: cangrelor P2Y12 (platelet) inhibitor
Drug: Clopidogrel 600 mg post cangrelor
over-encapsulated clopidogrel (600 mg)
Active Comparator: clopidogrel
Clopidogrel 300 mg or 600 mg administered pre or post PCI. Selection of dose and timing of dose were per investigator discretion.
During the PCI a placebo infusion was given to maintain the blinding of the trial. In addition, placebo capsules were administered at the end of the infusion mimic the 600mg post infusion dose provided in the cangrelor arm.
Drug: Clopidogrel - 300 or 600 mg (study arm)
Over encapsulated tablets.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01156571
|United States, South Carolina|
|Anderson Area Medical Center|
|Anderson, South Carolina, United States, 29621|