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
  Purpose

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


Condition Intervention Phase
Atherosclerosis
Percutaneous Coronary Intervention
Acute Coronary Syndrome
Drug: cangrelor P2Y12 (platelet) inhibitor
Drug: Clopidogrel - 300 or 600 mg (study arm)
Drug: Clopidogrel 600 mg post cangrelor
Phase 3

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
Official Title: A Clinical Trial Comparing Cangrelor to Clopidogrel Standard of Care Therapy in Subjects Who Require Percutaneous Coronary Intervention (CHAMPION PHOENIX)

Resource links provided by NLM:


Further study details as provided by The Medicines Company:

Primary Outcome Measures:
  • 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)


Secondary Outcome Measures:
  • 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


Enrollment: 11145
Study Start Date: September 2010
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

Drug: cangrelor P2Y12 (platelet) inhibitor Drug: Clopidogrel 600 mg post cangrelor
over-encapsulated clopidogrel (600 mg)
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.

Drug: Clopidogrel - 300 or 600 mg (study arm)
Over encapsulated tablets.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01156571

Locations
United States, South Carolina
Anderson Area Medical Center
Anderson, South Carolina, United States, 29621
Sponsors and Collaborators
The Medicines Company
  More Information

No publications provided by The Medicines Company

Additional 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

Additional relevant MeSH terms:
Atherosclerosis
Arteriosclerosis
Acute Coronary Syndrome
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Myocardial Ischemia
Heart Diseases
Angina Pectoris
Chest Pain
Pain
Signs and Symptoms
Clopidogrel
Ticlopidine
Cangrelor
Platelet Aggregation Inhibitors
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Fibrinolytic Agents
Fibrin Modulating Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on August 21, 2014