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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
The Medicines Company
ClinicalTrials.gov Identifier:
NCT01156571
First received: June 29, 2010
Last updated: January 2, 2014
Last verified: January 2014
Results First Received: April 22, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Atherosclerosis
Percutaneous Coronary Intervention
Acute Coronary Syndrome
Interventions: Drug: cangrelor P2Y12 (platelet) inhibitor
Drug: Clopidogrel - 300 or 600 mg (study arm)
Drug: Clopidogrel 600 mg post cangrelor

  Participant Flow
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Recruitment Details
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.


Pre-Assignment Details
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.

Reporting Groups
  Description
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 [1]   5564 [1] 
COMPLETED   5564 [2]   5545 [2] 
NOT COMPLETED   17   19 
[1] ITT: defined as all patients randomized.
[2] Completed = ITT patients who completed scheduled visits or developed a primary endpoint event



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
ITT population

Reporting Groups
  Description
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.

Total Total of all reporting groups

Baseline Measures
   Cangrelor Treatment Arm   Clopidogrel Treatment Arm   Total 
Overall Participants Analyzed 
[Units: Participants]
 5581   5564   11145 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   2892   2902   5794 
>=65 years   2689   2662   5351 
Age 
[Units: Years]
Mean (Standard Deviation)
 64.0  (11.0)   63.8  (11.0)   63.9  (11.0) 
Gender 
[Units: Participants]
     
Female   1599   1522   3121 
Male   3982   4042   8024 
Region of Enrollment 
[Units: Participants]
     
United States   2099   2089   4188 
Austria   302   300   602 
Brazil   78   80   158 
Bulgaria   169   167   336 
Czech Republic   814   816   1630 
Georgia   744   741   1485 
Germany   243   251   494 
Italy   311   310   621 
New Zealand   22   23   45 
Poland   352   350   702 
Russian Federation   296   286   582 
Thailand   151   151   302 


  Outcome Measures
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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 ]


  Serious Adverse Events
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Time Frame AEs and SAEs were collected from the time of randomization until 48 hours after randomization. If there was a delay between randomization and study drug initiation, AEs were collected from randomization through 48 hours after study drug initiation.
Additional Description No text entered.

Reporting Groups
  Description
Cangrelor Treatment Arm No text entered.
Clopidogrel Treatment Arm No text entered.

Serious Adverse Events
    Cangrelor Treatment Arm   Clopidogrel Treatment Arm
Total, serious adverse events     
# participants affected / at risk   122/5529 (2.21%)   105/5527 (1.90%) 
Blood and lymphatic system disorders     
Anaemia     
# participants affected / at risk   1/5529 (0.02%)   0/5527 (0.00%) 
Hypersplenism     
# participants affected / at risk   0/5529 (0.00%)   1/5527 (0.02%) 
Pancytopenia     
# participants affected / at risk   0/5529 (0.00%)   1/5527 (0.02%) 
Cardiac disorders     
acute coronary syndrome     
# participants affected / at risk   1/5529 (0.02%)   0/5527 (0.00%) 
acute myocardial infarction     
# participants affected / at risk   2/5529 (0.04%)   3/5527 (0.05%) 
angina pectoris     
# participants affected / at risk   1/5529 (0.02%)   1/5527 (0.02%) 
angina unstable     
# participants affected / at risk   2/5529 (0.04%)   1/5527 (0.02%) 
Arteriospasm coronary     
# participants affected / at risk   1/5529 (0.02%)   0/5527 (0.00%) 
atrial fibrillation     
# participants affected / at risk   2/5529 (0.04%)   2/5527 (0.04%) 
atrioventricular block complete     
# participants affected / at risk   3/5529 (0.05%)   3/5527 (0.05%) 
bradycardia     
# participants affected / at risk   1/5529 (0.02%)   1/5527 (0.02%) 
cardiac arrest     
# participants affected / at risk   5/5529 (0.09%)   8/5527 (0.14%) 
cardiac failure     
# participants affected / at risk   1/5529 (0.02%)   3/5527 (0.05%) 
cardiac failure acute     
# participants affected / at risk   1/5529 (0.02%)   0/5527 (0.00%) 
cardiac failure congestive     
# participants affected / at risk   3/5529 (0.05%)   3/5527 (0.05%) 
cardiac tamponade     
# participants affected / at risk   1/5529 (0.02%)   0/5527 (0.00%) 
cardio-respiratory arrest     
# participants affected / at risk   3/5529 (0.05%)   1/5527 (0.02%) 
cardiogenic shock     
# participants affected / at risk   12/5529 (0.22%)   6/5527 (0.11%) 
coronary artery disease     
# participants affected / at risk   0/5529 (0.00%)   1/5527 (0.02%) 
coronary artery dissection     
# participants affected / at risk   9/5529 (0.16%)   6/5527 (0.11%) 
coronary artery occlusion     
# participants affected / at risk   0/5529 (0.00%)   4/5527 (0.07%) 
coronary artery performation     
# participants affected / at risk   3/5529 (0.05%)   3/5527 (0.05%) 
Interventricluar septum rupture     
# participants affected / at risk   2/5529 (0.04%)   0/5527 (0.00%) 
myocardial infarction     
# participants affected / at risk   2/5529 (0.04%)   1/5527 (0.02%) 
mycardial rupture     
# participants affected / at risk   0/5529 (0.00%)   3/5527 (0.05%) 
nodal arrhythmia     
# participants affected / at risk   1/5529 (0.02%)   1/5527 (0.02%) 
percarditis     
# participants affected / at risk   0/5529 (0.00%)   1/5527 (0.02%) 
sick sinus syndrome     
# participants affected / at risk   1/5529 (0.02%)   1/5527 (0.02%) 
sinus arrest     
# participants affected / at risk   1/5529 (0.02%)   0/5527 (0.00%) 
ventricular rupture     
# participants affected / at risk   1/5529 (0.02%)   0/5527 (0.00%) 
ventricular asystole     
# participants affected / at risk   0/5529 (0.00%)   1/5527 (0.02%) 
ventricular fibrillation     
# participants affected / at risk   6/5529 (0.11%)   7/5527 (0.13%) 
ventricluar tachycardia     
# participants affected / at risk   5/5529 (0.09%)   3/5527 (0.05%) 
Gastrointestinal disorders     
gastroesophageal reflux disease     
# participants affected / at risk   0/5529 (0.00%)   1/5527 (0.02%) 
General disorders     
chest discomfort     
# participants affected / at risk   1/5529 (0.02%)   0/5527 (0.00%) 
chest pain     
# participants affected / at risk   5/5529 (0.09%)   2/5527 (0.04%) 
non-cardiac chest pain     
# participants affected / at risk   2/5529 (0.04%)   0/5527 (0.00%) 
pyrexia     
# participants affected / at risk   0/5529 (0.00%)   1/5527 (0.02%) 
thrombosis in device     
# participants affected / at risk   3/5529 (0.05%)   3/5527 (0.05%) 
Hepatobiliary disorders     
hepatic cirrhosis     
# participants affected / at risk   0/5529 (0.00%)   1/5527 (0.02%) 
Immune system disorders     
anaphylactic reaction     
# participants affected / at risk   2/5529 (0.04%)   0/5527 (0.00%) 
anaphylactic shock     
# participants affected / at risk   1/5529 (0.02%)   0/5527 (0.00%) 
hypersensitivity     
# participants affected / at risk   0/5529 (0.00%)   2/5527 (0.04%) 
Infections and infestations     
bronchitis     
# participants affected / at risk   1/5529 (0.02%)   0/5527 (0.00%) 
pneumonia     
# participants affected / at risk   1/5529 (0.02%)   1/5527 (0.02%) 
septic shock     
# participants affected / at risk   1/5529 (0.02%)   0/5527 (0.00%) 
small intestine gangrene     
# participants affected / at risk   1/5529 (0.02%)   0/5527 (0.00%) 
urinary tract infection     
# participants affected / at risk   0/5529 (0.00%)   1/5527 (0.02%) 
Injury, poisoning and procedural complications     
cardiac procedure complication     
# participants affected / at risk   0/5529 (0.00%)   1/5527 (0.02%) 
fall     
# participants affected / at risk   0/5529 (0.00%)   1/5527 (0.02%) 
head injury     
# participants affected / at risk   0/5529 (0.00%)   1/5527 (0.02%) 
medication error     
# participants affected / at risk   1/5529 (0.02%)   0/5527 (0.00%) 
postoperative ileus     
# participants affected / at risk   1/5529 (0.02%)   0/5527 (0.00%) 
subdural haematoma     
# participants affected / at risk   0/5529 (0.00%)   1/5527 (0.02%) 
vascular pseudoaneurysm     
# participants affected / at risk   1/5529 (0.02%)   0/5527 (0.00%) 
Investigations     
blood creatinine increased     
# participants affected / at risk   3/5529 (0.05%)   1/5527 (0.02%) 
electrocardiogram ST segment elevation     
# participants affected / at risk   0/5529 (0.00%)   1/5527 (0.02%) 
troponin increased     
# participants affected / at risk   1/5529 (0.02%)   2/5527 (0.04%) 
Metabolism and nutrition disorders     
diabetes mellitus     
# participants affected / at risk   1/5529 (0.02%)   0/5527 (0.00%) 
fluid overload     
# participants affected / at risk   0/5529 (0.00%)   1/5527 (0.02%) 
Musculoskeletal and connective tissue disorders     
compartment syndrome     
# participants affected / at risk   1/5529 (0.02%)   0/5527 (0.00%) 
neck pain     
# participants affected / at risk   0/5529 (0.00%)   1/5527 (0.02%) 
Nervous system disorders     
cerebrovascular accident     
# participants affected / at risk   0/5529 (0.00%)   2/5527 (0.04%) 
embolic cerebral infarction     
# participants affected / at risk   0/5529 (0.00%)   1/5527 (0.02%) 
ischaemic stroke     
# participants affected / at risk   2/5529 (0.04%)   1/5527 (0.02%) 
lethargy     
# participants affected / at risk   0/5529 (0.00%)   1/5527 (0.02%) 
migraine     
# participants affected / at risk   1/5529 (0.02%)   0/5527 (0.00%) 
presyncope     
# participants affected / at risk   1/5529 (0.02%)   3/5527 (0.05%) 
transient ischaemic attack     
# participants affected / at risk   1/5529 (0.02%)   1/5527 (0.02%) 
Psychiatric disorders     
delirium     
# participants affected / at risk   1/5529 (0.02%)   1/5527 (0.02%) 
mental status changes     
# participants affected / at risk   0/5529 (0.00%)   3/5527 (0.05%) 
Renal and urinary disorders     
nephrolithiasis     
# participants affected / at risk   1/5529 (0.02%)   0/5527 (0.00%) 
nephropathy toxic     
# participants affected / at risk   1/5529 (0.02%)   2/5527 (0.04%) 
renal failure     
# participants affected / at risk   2/5529 (0.04%)   1/5527 (0.02%) 
renal failure acute     
# participants affected / at risk   2/5529 (0.04%)   2/5527 (0.04%) 
renal impairment     
# participants affected / at risk   1/5529 (0.02%)   0/5527 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
aspiration     
# participants affected / at risk   1/5529 (0.02%)   0/5527 (0.00%) 
chronic obstructive pulmonary disease     
# participants affected / at risk   0/5529 (0.00%)   1/5527 (0.02%) 
dyspnoea     
# participants affected / at risk   1/5529 (0.02%)   0/5527 (0.00%) 
dyspnoea exertional     
# participants affected / at risk   1/5529 (0.02%)   0/5527 (0.00%) 
pulmonary embolism     
# participants affected / at risk   2/5529 (0.04%)   0/5527 (0.00%) 
pulmonary oedema     
# participants affected / at risk   6/5529 (0.11%)   3/5527 (0.05%) 
respiratory failure     
# participants affected / at risk   2/5529 (0.04%)   0/5527 (0.00%) 
Vascular disorders     
aortic dissection     
# participants affected / at risk   1/5529 (0.02%)   0/5527 (0.00%) 
arterial rupture     
# participants affected / at risk   2/5529 (0.04%)   2/5527 (0.04%) 
circulatory collapse     
# participants affected / at risk   0/5529 (0.00%)   1/5527 (0.02%) 
deep vein thrombosis     
# participants affected / at risk   1/5529 (0.02%)   0/5527 (0.00%) 
hypertension     
# participants affected / at risk   0/5529 (0.00%)   1/5527 (0.02%) 
hypotension     
# participants affected / at risk   7/5529 (0.13%)   3/5527 (0.05%) 




  Other Adverse Events


  Limitations and Caveats
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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.


  More Information
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Certain Agreements:  
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:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Meredith Todd - Sr. Director Program Management
Organization: The Medicines Company
phone: +1.973.290.6088
e-mail: meredith.todd@themedco.com


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: TMC-CAN-10-01
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