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

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ClinicalTrials.gov Identifier: NCT01156571
Recruitment Status : Completed
First Posted : July 5, 2010
Results First Posted : June 18, 2013
Last Update Posted : February 4, 2014
Sponsor:
Information provided by (Responsible Party):
The Medicines Company

Tracking Information
First Submitted Date  ICMJE June 29, 2010
First Posted Date  ICMJE July 5, 2010
Results First Submitted Date  ICMJE April 22, 2013
Results First Posted Date  ICMJE June 18, 2013
Last Update Posted Date February 4, 2014
Study Start Date  ICMJE September 2010
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 2, 2014)
The Composite Incidence of All-cause Mortality, Myocardial Infarction (MI), Ischemia-driven Revascularization (IDR) and Stent Thrombosis (ST) [ Time Frame: 48 hours after randomization ]
Clinical Events Committee (CEC)-adjudicated results (modified intent-to-treat [mITT] population)
Original Primary Outcome Measures  ICMJE
 (submitted: July 1, 2010)
A composite incidence of all-cause mortality, myocardial infarction, ischemia-driven revascularization and stent thrombosis [ Time Frame: 48 hours ]
Change History Complete list of historical versions of study NCT01156571 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 2, 2014)
  • Individual Incidence of Stent Thrombosis (ST), Death, Myocardial Infarction (MI) and Ischemia-driven Revascularization (IDR) [ Time Frame: 48 hours after randomization ]
    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 [ Time Frame: 48 hours after randomization ]
    GUSTO = Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Coronary Arteries trial
Original Secondary Outcome Measures  ICMJE
 (submitted: July 1, 2010)
Incidence of stent thrombosis [ Time Frame: 48 hours ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Clinical Trial Comparing Cangrelor to Clopidogrel Standard Therapy in Subjects Who Require Percutaneous Coronary Intervention (PCI) (CHAMPION PHOENIX)
Official Title  ICMJE A Clinical Trial Comparing Cangrelor to Clopidogrel Standard of Care Therapy in Subjects Who Require Percutaneous Coronary Intervention (CHAMPION PHOENIX)
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Atherosclerosis
  • Percutaneous Coronary Intervention
  • Acute Coronary Syndrome
Intervention  ICMJE
  • Drug: cangrelor P2Y12 (platelet) inhibitor
  • Drug: Clopidogrel - 300 or 600 mg (study arm)
    Over encapsulated tablets.
  • Drug: Clopidogrel 600 mg post cangrelor
    over-encapsulated clopidogrel (600 mg)
Study Arms  ICMJE
  • Experimental: cangrelor

    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.

    Interventions:
    • Drug: cangrelor P2Y12 (platelet) inhibitor
    • Drug: Clopidogrel 600 mg post cangrelor
  • Active Comparator: clopidogrel

    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: Drug: Clopidogrel - 300 or 600 mg (study arm)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 9, 2013)
11145
Original Estimated Enrollment  ICMJE
 (submitted: July 1, 2010)
10900
Actual Study Completion Date  ICMJE December 2012
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01156571
Other Study ID Numbers  ICMJE TMC-CAN-10-01
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party The Medicines Company
Study Sponsor  ICMJE The Medicines Company
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account The Medicines Company
Verification Date January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP