Skip to content

A Clinical Trial Comparing Cangrelor to Clopidogrel Standard Therapy in Subjects Who Require Percutaneous Coronary Intervention (PCI) (CHAMPION PHOENIX)

A Clinical Trial Comparing Cangrelor to Clopidogrel Standard of Care Therapy in Subjects Who Require Percutaneous Coronary Intervention (CHAMPION PHOENIX)

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01156571
Acronym
CHAMPION
Enrollment
11145
Registered
2010-07-05
Start date
2010-09-30
Completion date
2012-12-31
Last updated
2014-02-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Coronary Syndrome, Atherosclerosis, Percutaneous Coronary Intervention

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).

Interventions

DRUGcangrelor P2Y12 (platelet) inhibitor
DRUGClopidogrel - 300 or 600 mg (study arm)

Over encapsulated tablets.

DRUGClopidogrel 600 mg post cangrelor

over-encapsulated clopidogrel (600 mg)

Sponsors

The Medicines Company
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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): 1. Stable angina (SA) patients with diagnostic coronary angiography within 90 days prior to randomization demonstrating atherosclerosis 2. Non-ST-Segment Elevation Acute Coronary Syndrome (NSTE-ACS) patients with diagnostic coronary angiography within 72 hours prior to randomization demonstrating atherosclerosis 3. 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

Design outcomes

Primary

MeasureTime frameDescription
The Composite Incidence of All-cause Mortality, Myocardial Infarction (MI), Ischemia-driven Revascularization (IDR) and Stent Thrombosis (ST)48 hours after randomizationClinical Events Committee (CEC)-adjudicated results (modified intent-to-treat \[mITT\] population)

Secondary

MeasureTime frameDescription
Individual Incidence of Stent Thrombosis (ST), Death, Myocardial Infarction (MI) and Ischemia-driven Revascularization (IDR)48 hours after randomizationCEC-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 Mild48 hours after randomizationGUSTO = Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Coronary Arteries trial

Countries

United States

Participant flow

Recruitment details

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.

Pre-assignment details

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.

Participants by arm

ArmCount
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.
5,581
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.
5,564
Total11,145

Baseline characteristics

CharacteristicCangrelor Treatment ArmClopidogrel Treatment ArmTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
2689 Participants2662 Participants5351 Participants
Age, Categorical
Between 18 and 65 years
2892 Participants2902 Participants5794 Participants
Age, Continuous64.0 years
STANDARD_DEVIATION 11
63.8 years
STANDARD_DEVIATION 11
63.9 years
STANDARD_DEVIATION 11
Region of Enrollment
Austria
302 participants300 participants602 participants
Region of Enrollment
Brazil
78 participants80 participants158 participants
Region of Enrollment
Bulgaria
169 participants167 participants336 participants
Region of Enrollment
Czech Republic
814 participants816 participants1630 participants
Region of Enrollment
Georgia
744 participants741 participants1485 participants
Region of Enrollment
Germany
243 participants251 participants494 participants
Region of Enrollment
Italy
311 participants310 participants621 participants
Region of Enrollment
New Zealand
22 participants23 participants45 participants
Region of Enrollment
Poland
352 participants350 participants702 participants
Region of Enrollment
Russian Federation
296 participants286 participants582 participants
Region of Enrollment
Thailand
151 participants151 participants302 participants
Region of Enrollment
United States
2099 participants2089 participants4188 participants
Sex: Female, Male
Female
1599 Participants1522 Participants3121 Participants
Sex: Female, Male
Male
3982 Participants4042 Participants8024 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 5,5290 / 5,527
serious
Total, serious adverse events
122 / 5,529105 / 5,527

Outcome results

Primary

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)

Time frame: 48 hours after randomization

ArmMeasureValue (NUMBER)
Cangrelor Treatment ArmThe Composite Incidence of All-cause Mortality, Myocardial Infarction (MI), Ischemia-driven Revascularization (IDR) and Stent Thrombosis (ST)257 participants
Clopidogrel Treatment ArmThe Composite Incidence of All-cause Mortality, Myocardial Infarction (MI), Ischemia-driven Revascularization (IDR) and Stent Thrombosis (ST)322 participants
Secondary

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

Time frame: 48 hours after randomization

ArmMeasureGroupValue (NUMBER)
Cangrelor Treatment ArmIncidence of Major/Minor Non-coronary Artery Bypass Graft (CABG)-Related Hemorrhage by Clinical Relevant Criteria - GUSTO Severe/Life-threatening, Moderate and MildGUSTO severe or moderate31 participants
Cangrelor Treatment ArmIncidence of Major/Minor Non-coronary Artery Bypass Graft (CABG)-Related Hemorrhage by Clinical Relevant Criteria - GUSTO Severe/Life-threatening, Moderate and MildTIMI minor9 participants
Cangrelor Treatment ArmIncidence of Major/Minor Non-coronary Artery Bypass Graft (CABG)-Related Hemorrhage by Clinical Relevant Criteria - GUSTO Severe/Life-threatening, Moderate and MildGUSTO moderate22 participants
Cangrelor Treatment ArmIncidence of Major/Minor Non-coronary Artery Bypass Graft (CABG)-Related Hemorrhage by Clinical Relevant Criteria - GUSTO Severe/Life-threatening, Moderate and MildTIMI major or minor14 participants
Cangrelor Treatment ArmIncidence of Major/Minor Non-coronary Artery Bypass Graft (CABG)-Related Hemorrhage by Clinical Relevant Criteria - GUSTO Severe/Life-threatening, Moderate and MildTIMI major5 participants
Cangrelor Treatment ArmIncidence of Major/Minor Non-coronary Artery Bypass Graft (CABG)-Related Hemorrhage by Clinical Relevant Criteria - GUSTO Severe/Life-threatening, Moderate and MildAny blood transfusion25 participants
Cangrelor Treatment ArmIncidence of Major/Minor Non-coronary Artery Bypass Graft (CABG)-Related Hemorrhage by Clinical Relevant Criteria - GUSTO Severe/Life-threatening, Moderate and MildGUSTO severe/life threatening9 participants
Clopidogrel Treatment ArmIncidence of Major/Minor Non-coronary Artery Bypass Graft (CABG)-Related Hemorrhage by Clinical Relevant Criteria - GUSTO Severe/Life-threatening, Moderate and MildAny blood transfusion16 participants
Clopidogrel Treatment ArmIncidence of Major/Minor Non-coronary Artery Bypass Graft (CABG)-Related Hemorrhage by Clinical Relevant Criteria - GUSTO Severe/Life-threatening, Moderate and MildGUSTO severe/life threatening6 participants
Clopidogrel Treatment ArmIncidence of Major/Minor Non-coronary Artery Bypass Graft (CABG)-Related Hemorrhage by Clinical Relevant Criteria - GUSTO Severe/Life-threatening, Moderate and MildGUSTO moderate13 participants
Clopidogrel Treatment ArmIncidence of Major/Minor Non-coronary Artery Bypass Graft (CABG)-Related Hemorrhage by Clinical Relevant Criteria - GUSTO Severe/Life-threatening, Moderate and MildGUSTO severe or moderate19 participants
Clopidogrel Treatment ArmIncidence of Major/Minor Non-coronary Artery Bypass Graft (CABG)-Related Hemorrhage by Clinical Relevant Criteria - GUSTO Severe/Life-threatening, Moderate and MildTIMI major5 participants
Clopidogrel Treatment ArmIncidence of Major/Minor Non-coronary Artery Bypass Graft (CABG)-Related Hemorrhage by Clinical Relevant Criteria - GUSTO Severe/Life-threatening, Moderate and MildTIMI minor3 participants
Clopidogrel Treatment ArmIncidence of Major/Minor Non-coronary Artery Bypass Graft (CABG)-Related Hemorrhage by Clinical Relevant Criteria - GUSTO Severe/Life-threatening, Moderate and MildTIMI major or minor8 participants
Secondary

Individual Incidence of Stent Thrombosis (ST), Death, Myocardial Infarction (MI) and Ischemia-driven Revascularization (IDR)

CEC-adjudicated results (mITT population)

Time frame: 48 hours after randomization

ArmMeasureGroupValue (NUMBER)
Cangrelor Treatment ArmIndividual Incidence of Stent Thrombosis (ST), Death, Myocardial Infarction (MI) and Ischemia-driven Revascularization (IDR)MI (myocardial infarction)207 participants
Cangrelor Treatment ArmIndividual Incidence of Stent Thrombosis (ST), Death, Myocardial Infarction (MI) and Ischemia-driven Revascularization (IDR)Stent Thrombosis46 participants
Cangrelor Treatment ArmIndividual Incidence of Stent Thrombosis (ST), Death, Myocardial Infarction (MI) and Ischemia-driven Revascularization (IDR)IDR (ischemia-driven revascularization)28 participants
Cangrelor Treatment ArmIndividual Incidence of Stent Thrombosis (ST), Death, Myocardial Infarction (MI) and Ischemia-driven Revascularization (IDR)Death18 participants
Clopidogrel Treatment ArmIndividual Incidence of Stent Thrombosis (ST), Death, Myocardial Infarction (MI) and Ischemia-driven Revascularization (IDR)IDR (ischemia-driven revascularization)38 participants
Clopidogrel Treatment ArmIndividual Incidence of Stent Thrombosis (ST), Death, Myocardial Infarction (MI) and Ischemia-driven Revascularization (IDR)Stent Thrombosis74 participants
Clopidogrel Treatment ArmIndividual Incidence of Stent Thrombosis (ST), Death, Myocardial Infarction (MI) and Ischemia-driven Revascularization (IDR)MI (myocardial infarction)255 participants
Clopidogrel Treatment ArmIndividual Incidence of Stent Thrombosis (ST), Death, Myocardial Infarction (MI) and Ischemia-driven Revascularization (IDR)Death18 participants

Source: ClinicalTrials.gov · Data processed: Mar 24, 2026