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 |
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Recruitment Status :
Completed
First Posted : July 5, 2010
Results First Posted : June 18, 2013
Last Update Posted : February 4, 2014
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| Condition or disease | Intervention/treatment | 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 (Clinical Trial) |
| Actual Enrollment : | 11145 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, 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) |
| Study Start Date : | September 2010 |
| Actual Primary Completion Date : | December 2012 |
| Actual Study Completion Date : | December 2012 |
| Arm | Intervention/treatment |
|---|---|
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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) |
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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. |
- 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)
- 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
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
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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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01156571
| United States, South Carolina | |
| Anderson Area Medical Center | |
| Anderson, South Carolina, United States, 29621 | |
| Responsible Party: | The Medicines Company |
| ClinicalTrials.gov Identifier: | NCT01156571 |
| Other Study ID Numbers: |
TMC-CAN-10-01 |
| First Posted: | July 5, 2010 Key Record Dates |
| Results First Posted: | June 18, 2013 |
| Last Update Posted: | February 4, 2014 |
| Last Verified: | January 2014 |
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Acute Coronary Syndrome Atherosclerosis Myocardial Ischemia Heart Diseases Cardiovascular Diseases Vascular Diseases Arteriosclerosis Arterial Occlusive Diseases Clopidogrel |
Cangrelor Platelet Aggregation Inhibitors Purinergic P2Y Receptor Antagonists Purinergic P2 Receptor Antagonists Purinergic Antagonists Purinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs |