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

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  
Number of Participants  
[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


No publications provided by The Medicines Company

Publications automatically indexed to this study:

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