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

June 29, 2010
January 2, 2014
September 2010
December 2012   (final data collection date for primary outcome measure)
The Composite Incidence of All-cause Mortality, Myocardial Infarction (MI), Ischemia-driven Revascularization (IDR) and Stent Thrombosis (ST) [ Time Frame: 48 hours after randomization ] [ Designated as safety issue: No ]
Clinical Events Committee (CEC)-adjudicated results (modified intent-to-treat [mITT] population)
A composite incidence of all-cause mortality, myocardial infarction, ischemia-driven revascularization and stent thrombosis [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01156571 on ClinicalTrials.gov Archive Site
  • Individual Incidence of Stent Thrombosis (ST), Death, Myocardial Infarction (MI) and Ischemia-driven Revascularization (IDR) [ Time Frame: 48 hours after randomization ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    GUSTO = Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Coronary Arteries trial
Incidence of stent thrombosis [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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)

The study is designed to compare the efficacy and safety profile of cangrelor to standard of care in patients require percutaneous coronary intervention (PCI).

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Atherosclerosis
  • Percutaneous Coronary Intervention
  • Acute Coronary Syndrome
  • 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)
  • 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)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
11145
December 2012
December 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01156571
TMC-CAN-10-01
Not Provided
The Medicines Company
The Medicines Company
Not Provided
Not Provided
The Medicines Company
January 2014

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