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

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

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

Conditions
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Atherosclerosis, Percutaneous Coronary Intervention, Acute Coronary Syndrome

Intervention / Treatment
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* Drug: cangrelor P2Y12 (platelet) inhibitor
* Drug: Clopidogrel - 300 or 600 mg (study arm)
* Drug: Clopidogrel 600 mg post cangrelor


Participation Criteria
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Eligibility Criteria
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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): Stable angina (SA) patients with diagnostic coronary angiography within 90 days prior to randomization demonstrating atherosclerosis Non-ST-Segment Elevation Acute Coronary Syndrome (NSTE-ACS) patients with diagnostic coronary angiography within 72 hours prior to randomization demonstrating atherosclerosis 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: cangrelor<br>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<br> <br> Drug: Clopidogrel 600 mg post cangrelor<br>* over-encapsulated clopidogrel (600 mg)<br>|
| Active Comparator: clopidogrel<br>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)<br>* Over encapsulated tablets.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Composite Incidence of All-cause Mortality, Myocardial Infarction (MI), Ischemia-driven Revascularization (IDR) and Stent Thrombosis (ST) | Clinical Events Committee (CEC)-adjudicated results (modified intent-to-treat [mITT] population) | 48 hours after randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Individual Incidence of Stent Thrombosis (ST), Death, Myocardial Infarction (MI) and Ischemia-driven Revascularization (IDR) | CEC-adjudicated results (mITT population) | 48 hours after randomization | 
| Incidence of Major/Minor Non-coronary Artery Bypass Graft (CABG)-Related Hemorrhage by Clinical Relevant Criteria - GUSTO Severe/Life-threatening, Moderate and Mild | GUSTO = Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Coronary Arteries trial | 48 hours after randomization |