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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;   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


  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


  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
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  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