Back to resultsA Clinical Trial Comparing Cangrelor to Clopidogrel Standard Therapy in Subjects Who Require Percutaneous Coronary Intervention (PCI) (CHAMPION PHOENIX) (CHAMPION)
Primary Purpose
Atherosclerosis, Percutaneous Coronary Intervention, Acute Coronary Syndrome
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
cangrelor P2Y12 (platelet) inhibitor
Clopidogrel - 300 or 600 mg (study arm)
Clopidogrel 600 mg post cangrelor
Sponsored by
About this trial
This is an interventional treatment trial for Atherosclerosis
Eligibility Criteria
Inclusion Criteria:
Patients may be included in the study if they meet all of the following criteria:
- Male or non-pregnant female at least 18 years of age
Patients undergoing percutaneous coronary intervention (PCI):
- Stable angina (SA) patients with diagnostic coronary angiography within 90 days prior to randomization demonstrating atherosclerosis
- Non-ST-Segment Elevation Acute Coronary Syndrome (NSTE-ACS) patients with diagnostic coronary angiography within 72 hours prior to randomization demonstrating atherosclerosis
- ST-segment elevation myocardial infarction (STEMI) patients (diagnostic angiography not required)
- Provide written informed consent
Exclusion Criteria:
Patients will be excluded from the study if any of the following exclusion criteria apply prior to randomization:
- Receipt of any P2Y12 inhibitor at any time in the 7 days preceding randomization
- Eptifibatide and tirofiban usage within 12 hours preceding randomization (most recent dose must have been administered ≥12 hours prior to randomization)
- Abciximab usage within 7 days preceding randomization
- Receipt of fibrinolytic therapy in the 12 hours preceding randomization
- Increased bleeding risk: ischemic stroke within the last year or any previous hemorrhagic stroke; tumor, cerebral arteriovenous malformation, or intracranial aneurysm; recent (<1 month) trauma or major surgery (including bypass surgery); currently receiving warfarin; active bleeding
Sites / Locations
- Anderson Area Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
cangrelor
clopidogrel
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
The Composite Incidence of All-cause Mortality, Myocardial Infarction (MI), Ischemia-driven Revascularization (IDR) and Stent Thrombosis (ST)
Clinical Events Committee (CEC)-adjudicated results (modified intent-to-treat [mITT] population)
Secondary Outcome Measures
Individual Incidence of Stent Thrombosis (ST), Death, Myocardial Infarction (MI) and Ischemia-driven Revascularization (IDR)
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
GUSTO = Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Coronary Arteries trial
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01156571
Brief Title
A Clinical Trial Comparing Cangrelor to Clopidogrel Standard Therapy in Subjects Who Require Percutaneous Coronary Intervention (PCI) (CHAMPION PHOENIX)
Acronym
CHAMPION
Official Title
A Clinical Trial Comparing Cangrelor to Clopidogrel Standard of Care Therapy in Subjects Who Require Percutaneous Coronary Intervention (CHAMPION PHOENIX)
Study Type
Interventional
2. Study Status
Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Medicines Company
4. Oversight
5. Study Description
Brief Summary
The study is designed to compare the efficacy and safety profile of cangrelor to standard of care in patients require percutaneous coronary intervention (PCI).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atherosclerosis, Percutaneous Coronary Intervention, Acute Coronary Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
11145 (Actual)
8. Arms, Groups, and Interventions
Arm Title
cangrelor
Arm Type
Experimental
Arm Description
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.
Arm Title
clopidogrel
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
cangrelor P2Y12 (platelet) inhibitor
Intervention Type
Drug
Intervention Name(s)
Clopidogrel - 300 or 600 mg (study arm)
Intervention Description
Over encapsulated tablets.
Intervention Type
Drug
Intervention Name(s)
Clopidogrel 600 mg post cangrelor
Intervention Description
over-encapsulated clopidogrel (600 mg)
Primary Outcome Measure Information:
Title
The Composite Incidence of All-cause Mortality, Myocardial Infarction (MI), Ischemia-driven Revascularization (IDR) and Stent Thrombosis (ST)
Description
Clinical Events Committee (CEC)-adjudicated results (modified intent-to-treat [mITT] population)
Time Frame
48 hours after randomization
Secondary Outcome Measure Information:
Title
Individual Incidence of Stent Thrombosis (ST), Death, Myocardial Infarction (MI) and Ischemia-driven Revascularization (IDR)
Description
CEC-adjudicated results (mITT population)
Time Frame
48 hours after randomization
Title
Incidence of Major/Minor Non-coronary Artery Bypass Graft (CABG)-Related Hemorrhage by Clinical Relevant Criteria - GUSTO Severe/Life-threatening, Moderate and Mild
Description
GUSTO = Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Coronary Arteries trial
Time Frame
48 hours after randomization
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients may be included in the study if they meet all of the following criteria:
Male or non-pregnant female at least 18 years of age
Patients undergoing percutaneous coronary intervention (PCI):
Stable angina (SA) patients with diagnostic coronary angiography within 90 days prior to randomization demonstrating atherosclerosis
Non-ST-Segment Elevation Acute Coronary Syndrome (NSTE-ACS) patients with diagnostic coronary angiography within 72 hours prior to randomization demonstrating atherosclerosis
ST-segment elevation myocardial infarction (STEMI) patients (diagnostic angiography not required)
Provide written informed consent
Exclusion Criteria:
Patients will be excluded from the study if any of the following exclusion criteria apply prior to randomization:
Receipt of any P2Y12 inhibitor at any time in the 7 days preceding randomization
Eptifibatide and tirofiban usage within 12 hours preceding randomization (most recent dose must have been administered ≥12 hours prior to randomization)
Abciximab usage within 7 days preceding randomization
Receipt of fibrinolytic therapy in the 12 hours preceding randomization
Increased bleeding risk: ischemic stroke within the last year or any previous hemorrhagic stroke; tumor, cerebral arteriovenous malformation, or intracranial aneurysm; recent (<1 month) trauma or major surgery (including bypass surgery); currently receiving warfarin; active bleeding
Facility Information:
Facility Name
Anderson Area Medical Center
City
Anderson
State/Province
South Carolina
ZIP/Postal Code
29621
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
35196863
Citation
Peterson BE, Harrington RA, Stone GW, Steg PG, Gibson CM, Hamm CW, Price MJ, Lopes RD, Leonardi S, Prats J, Deliargyris EN, Mahaffey KW, White HD, Bhatt DL. Effect of Platelet Inhibition by Cangrelor Among Obese Patients Undergoing Coronary Stenting: Insights From CHAMPION. Circ Cardiovasc Interv. 2022 Mar;15(3):e011069. doi: 10.1161/CIRCINTERVENTIONS.121.011069. Epub 2022 Feb 24.
Results Reference
derived
PubMed Identifier
34915723
Citation
Cavender MA, Harrington RA, Stone GW, Steg PG, Gibson CM, Hamm CW, Price MJ, Lopes RD, Leonardi S, Deliargyris EN, Prats J, Mahaffey KW, White HD, Bhatt DL; CHAMPION PHOENIX Investigators*. Ischemic Events Occur Early in Patients Undergoing Percutaneous Coronary Intervention and Are Reduced With Cangrelor: Findings From CHAMPION PHOENIX. Circ Cardiovasc Interv. 2022 Jan;15(1):e010390. doi: 10.1161/CIRCINTERVENTIONS.120.010390. Epub 2021 Dec 17.
Results Reference
derived
PubMed Identifier
31296081
Citation
Olivier CB, Bhatt DL, Leonardi S, Stone GW, Gibson CM, Steg PG, Hamm CW, Wilson MD, Mangum S, Price MJ, Prats J, White HD, Lopes RD, Harrington RA, Mahaffey KW; CHAMPION PHOENIX Investigators *. Central Adjudication Identified Additional and Prognostically Important Myocardial Infarctions in Patients Undergoing Percutaneous Coronary Intervention. Circ Cardiovasc Interv. 2019 Jul;12(7):e007342. doi: 10.1161/CIRCINTERVENTIONS.118.007342. Epub 2019 Jul 12.
Results Reference
derived
PubMed Identifier
30871355
Citation
Abtan J, Ducrocq G, Steg PG, Stone GW, Mahaffey KW, Gibson CM, Hamm CW, Price MJ, Prats J, Deliargyris EN, White HD, Harrington RA, Bhatt DL. Periprocedural Outcomes According to Timing of Clopidogrel Loading Dose in Patients Who Did Not Receive P2Y12 Inhibitor Pretreatment. Circ Cardiovasc Interv. 2019 Mar;12(3):e007445. doi: 10.1161/CIRCINTERVENTIONS.118.007445.
Results Reference
derived
PubMed Identifier
30563770
Citation
Abtan J, Ducrocq G, Steg PG, Stone GW, Mahaffey KW, Gibson CM, Hamm C, Price MJ, Prats J, Elkin S, Deliargyris EN, White HD, Menozzi A, Harrington RA, Bhatt DL; MPH on Behalf of the CHAMPION PHOENIX Investigators. Characteristics and outcomes of patients requiring bailout use of glycoprotein IIb/IIIa inhibitors for thrombotic complications of percutaneous coronary intervention: An analysis from the CHAMPION PHOENIX trial. Int J Cardiol. 2019 Mar 1;278:217-222. doi: 10.1016/j.ijcard.2018.11.114. Epub 2018 Nov 23.
Results Reference
derived
PubMed Identifier
30203006
Citation
Stone GW, Genereux P, Harrington RA, White HD, Gibson CM, Steg PG, Hamm CW, Mahaffey KW, Price MJ, Prats J, Deliargyris EN, Bhatt DL. Impact of lesion complexity on peri-procedural adverse events and the benefit of potent intravenous platelet adenosine diphosphate receptor inhibition after percutaneous coronary intervention: core laboratory analysis from 10 854 patients from the CHAMPION PHOENIX trial. Eur Heart J. 2018 Dec 7;39(46):4112-4121. doi: 10.1093/eurheartj/ehy562. Erratum In: Eur Heart J. 2019 Apr 14;40(15):1201.
Results Reference
derived
PubMed Identifier
29632238
Citation
Groves EM, Bhatt DL, Steg PG, Deliargyris EN, Stone GW, Gibson CM, Hamm CW, Mahaffey KW, White HD, Angiolillo DJ, Prats J, Harrington RA, Price MJ. Incidence, Predictors, and Outcomes of Acquired Thrombocytopenia After Percutaneous Coronary Intervention: A Pooled, Patient-Level Analysis of the CHAMPION Trials (Cangrelor Versus Standard Therapy to Achieve Optimal Management of Platelet Inhibition). Circ Cardiovasc Interv. 2018 Apr;11(4):e005635. doi: 10.1161/CIRCINTERVENTIONS.117.005635. Erratum In: Circ Cardiovasc Interv. 2018 Sep;11(9):e000036. Angiolillo, Dominick [corrected to Angiolillo, Dominick J].
Results Reference
derived
PubMed Identifier
28988157
Citation
Vaduganathan M, Harrington RA, Stone GW, Steg G, Gibson CM, Hamm CW, Price MJ, Lopes RD, Leonardi S, Deliargyris EN, Prats J, Mahaffey KW, White HD, Bhatt DL. Short- and long-term mortality following bleeding events in patients undergoing percutaneous coronary intervention: insights from four validated bleeding scales in the CHAMPION trials. EuroIntervention. 2018 Feb 2;13(15):e1841-e1849. doi: 10.4244/EIJ-D-17-00723.
Results Reference
derived
PubMed Identifier
28801539
Citation
Cavender MA, Bhatt DL, Stone GW, Steg PG, Gibson CM, Hamm CW, Price MJ, Prats J, Elkin S, Deliargyris EN, Mahaffey KW, White HD, Harrington RA; CHAMPION PHOENIX Investigators*. Cangrelor in Older Patients Undergoing Percutaneous Coronary Intervention: Findings From CHAMPION PHOENIX. Circ Cardiovasc Interv. 2017 Aug;10(8):e005257. doi: 10.1161/CIRCINTERVENTIONS.117.005257.
Results Reference
derived
PubMed Identifier
28382371
Citation
Parker WA, Bhatt DL, Prats J, Day JRS, Steg PG, Stone GW, Hamm CW, Mahaffey KW, Price MJ, Gibson CM, White HD, Storey RF; CHAMPION PHOENIX Investigators. Characteristics of dyspnoea and associated clinical outcomes in the CHAMPION PHOENIX study. Thromb Haemost. 2017 Jun 2;117(6):1093-1100. doi: 10.1160/TH16-12-0958. Epub 2017 Apr 6.
Results Reference
derived
PubMed Identifier
28081827
Citation
Vaduganathan M, Harrington RA, Stone GW, Deliargyris EN, Steg PG, Gibson CM, Hamm CW, Price MJ, Menozzi A, Prats J, Elkin S, Mahaffey KW, White HD, Bhatt DL; CHAMPION Investigators. Cangrelor With and Without Glycoprotein IIb/IIIa Inhibitors in Patients Undergoing Percutaneous Coronary Intervention. J Am Coll Cardiol. 2017 Jan 17;69(2):176-185. doi: 10.1016/j.jacc.2016.10.055.
Results Reference
derived
PubMed Identifier
27902833
Citation
Vaduganathan M, Harrington RA, Stone GW, Deliargyris EN, Steg PG, Gibson CM, Hamm CW, Price MJ, Menozzi A, Prats J, Elkin S, Mahaffey KW, White HD, Bhatt DL. Evaluation of Ischemic and Bleeding Risks Associated With 2 Parenteral Antiplatelet Strategies Comparing Cangrelor With Glycoprotein IIb/IIIa Inhibitors: An Exploratory Analysis From the CHAMPION Trials. JAMA Cardiol. 2017 Feb 1;2(2):127-135. doi: 10.1001/jamacardio.2016.4556.
Results Reference
derived
PubMed Identifier
27659566
Citation
Abtan J, Steg PG, Stone GW, Mahaffey KW, Gibson CM, Hamm CW, Price MJ, Abnousi F, Prats J, Deliargyris EN, White HD, Harrington RA, Bhatt DL; CHAMPION PHOENIX Investigators. Efficacy and Safety of Cangrelor in Preventing Periprocedural Complications in Patients With Stable Angina and Acute Coronary Syndromes Undergoing Percutaneous Coronary Intervention: The CHAMPION PHOENIX Trial. JACC Cardiovasc Interv. 2016 Sep 26;9(18):1905-13. doi: 10.1016/j.jcin.2016.06.046.
Results Reference
derived
PubMed Identifier
27482008
Citation
Cavender MA, Bhatt DL, Stone GW, White HD, Steg PG, Gibson CM, Hamm CW, Price MJ, Leonardi S, Prats J, Deliargyris EN, Mahaffey KW, Harrington RA; CHAMPION PHOENIX Investigators*. Consistent Reduction in Periprocedural Myocardial Infarction With Cangrelor as Assessed by Multiple Definitions: Findings From CHAMPION PHOENIX (Cangrelor Versus Standard Therapy to Achieve Optimal Management of Platelet Inhibition). Circulation. 2016 Sep 6;134(10):723-33. doi: 10.1161/CIRCULATIONAHA.115.020829. Epub 2016 Aug 1.
Results Reference
derived
PubMed Identifier
27313282
Citation
Vaduganathan M, Harrington RA, Stone GW, Steg PG, Gibson CM, Hamm CW, Price MJ, Prats J, Deliargyris EN, Mahaffey KW, White HD, Bhatt DL. Variation in Patient Profiles and Outcomes in US and Non-US Subgroups of the Cangrelor Versus Standard Therapy to Achieve Optimal Management of Platelet Inhibition (CHAMPION) PHOENIX Trial. Circ Cardiovasc Interv. 2016 Jun;9(6):e003612. doi: 10.1161/CIRCINTERVENTIONS.116.003612.
Results Reference
derived
PubMed Identifier
26762525
Citation
O'Donoghue ML, Bhatt DL, Stone GW, Steg PG, Gibson CM, Hamm CW, Price MJ, Prats J, Liu T, Deliargyris EN, Mahaffey KW, White HD, Harrington RA; CHAMPION PHOENIX Investigators. Efficacy and Safety of Cangrelor in Women Versus Men During Percutaneous Coronary Intervention: Insights From the Cangrelor versus Standard Therapy to Achieve Optimal Management of Platelet Inhibition (CHAMPION PHOENIX) Trial. Circulation. 2016 Jan 19;133(3):248-55. doi: 10.1161/CIRCULATIONAHA.115.017300.
Results Reference
derived
PubMed Identifier
26400827
Citation
Gutierrez JA, Harrington RA, Blankenship JC, Stone GW, Steg PG, Gibson CM, Hamm CW, Price MJ, Genereux P, Prats J, Deliargyris EN, Mahaffey KW, White HD, Bhatt DL; CHAMPION PHOENIX Investigators. The effect of cangrelor and access site on ischaemic and bleeding events: insights from CHAMPION PHOENIX. Eur Heart J. 2016 Apr 7;37(14):1122-30. doi: 10.1093/eurheartj/ehv498. Epub 2015 Sep 23.
Results Reference
derived
PubMed Identifier
24184169
Citation
Genereux P, Stone GW, Harrington RA, Gibson CM, Steg PG, Brener SJ, Angiolillo DJ, Price MJ, Prats J, LaSalle L, Liu T, Todd M, Skerjanec S, Hamm CW, Mahaffey KW, White HD, Bhatt DL; CHAMPION PHOENIX Investigators. Impact of intraprocedural stent thrombosis during percutaneous coronary intervention: insights from the CHAMPION PHOENIX Trial (Clinical Trial Comparing Cangrelor to Clopidogrel Standard of Care Therapy in Subjects Who Require Percutaneous Coronary Intervention). J Am Coll Cardiol. 2014 Feb 25;63(7):619-629. doi: 10.1016/j.jacc.2013.10.022. Epub 2013 Oct 30.
Results Reference
derived
PubMed Identifier
23473369
Citation
Bhatt DL, Stone GW, Mahaffey KW, Gibson CM, Steg PG, Hamm CW, Price MJ, Leonardi S, Gallup D, Bramucci E, Radke PW, Widimsky P, Tousek F, Tauth J, Spriggs D, McLaurin BT, Angiolillo DJ, Genereux P, Liu T, Prats J, Todd M, Skerjanec S, White HD, Harrington RA; CHAMPION PHOENIX Investigators. Effect of platelet inhibition with cangrelor during PCI on ischemic events. N Engl J Med. 2013 Apr 4;368(14):1303-13. doi: 10.1056/NEJMoa1300815. Epub 2013 Mar 10.
Results Reference
derived
PubMed Identifier
22607853
Citation
Leonardi S, Mahaffey KW, White HD, Gibson CM, Stone GW, Steg GW, Hamm CW, Price MJ, Todd M, Dietrich M, Gallup D, Liu T, Skerjanec S, Harrington RA, Bhatt DL. Rationale and design of the Cangrelor versus standard therapy to acHieve optimal Management of Platelet InhibitiON PHOENIX trial. Am Heart J. 2012 May;163(5):768-776.e2. doi: 10.1016/j.ahj.2012.02.018.
Results Reference
derived
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A Clinical Trial Comparing Cangrelor to Clopidogrel Standard Therapy in Subjects Who Require Percutaneous Coronary Intervention (PCI) (CHAMPION PHOENIX)
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