A Clinical Trial Comparing Cangrelor to Clopidogrel Standard Therapy in Subjects Who Require Percutaneous Coronary Intervention (PCI) (CHAMPION PHOENIX) (CHAMPION)
|Study Design:||Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor); Primary Purpose: Treatment|
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
|Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations|
Date first patient enrolled: 30 Sep 2010 Date last patient completed: 14 Nov 2012
This trial enrolled the full spectrum of patients who required PCI (SA, NSTE-ACS, STEMI). Randomization occurred after confirmation of need for PCI (after diagnostic angiogram in all cases, except for STEMI patients). Patients were followed through 30-days.
|Significant events and approaches for the overall study following participant enrollment, but prior to group assignment|
|Due to the nature of the disease, STEMI patients were permitted to be randomized upon ECG confirmation and prior to confirmation of need for PCI (prior to diagnostic angiography). Therefore in some cases, STEMI patients did not require PCI and therefore did not receive all study drug.|
|Cangrelor Treatment Arm||
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.
Immediately after discontinuation of infusion, an oral transition dose of clopidogrel 600 mg was administered.
Patients also received oral placebo capsules, administered as soon as possible following randomization at investigator discretion. These capsules were designed to match the clopidogrel 600 mg or 300 mg loading dose.
|Clopidogrel Treatment Arm||
Oral clopidogrel was administered as soon as possible following randomization at investigator discretion at a loading dose of either 600 mg or 300 mg as specified by the investigator.
Patients in the clopidogrel treatment arm received IV placebo for 2 hours or end of the PCI procedure, whichever was longer. At the discretion of the treating physician, the infusion could be continued for a total duration of 4 hours.
At the end of IV placebo infusion, patients were given oral placebo capsules matching the oral clopidogrel transition dose.
Participant Flow: Overall Study
|Cangrelor Treatment Arm||Clopidogrel Treatment Arm|
|STARTED||5581 ||5564 |
|COMPLETED||5564 ||5545 |
|||ITT: defined as all patients randomized.|
|||Completed = ITT patients who completed scheduled visits or developed a primary endpoint event|
|1. Primary:||The Composite Incidence of All-cause Mortality, Myocardial Infarction (MI), Ischemia-driven Revascularization (IDR) and Stent Thrombosis (ST) [ Time Frame: 48 hours after randomization ]|
|2. Secondary:||Individual Incidence of Stent Thrombosis (ST), Death, Myocardial Infarction (MI) and Ischemia-driven Revascularization (IDR) [ Time Frame: 48 hours after randomization ]|
|3. Secondary:||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 ]|
Limitations and Caveats
|Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data|
|No text entered.|
|Principal Investigators are NOT employed by the organization sponsoring the study.|
|There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.|
The agreement is:
Results Point of Contact:
Organization: The Medicines Company
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
|Responsible Party:||The Medicines Company|
|ClinicalTrials.gov Identifier:||NCT01156571 History of Changes|
|Other Study ID Numbers:||
|Study First Received:||June 29, 2010|
|Results First Received:||April 22, 2013|
|Last Updated:||January 2, 2014|
|Health Authority:||United States: Food and Drug Administration