Status:
COMPLETED
A Clinical Trial Comparing Cangrelor to Clopidogrel Standard Therapy in Subjects Who Require Percutaneous Coronary Intervention (PCI) (CHAMPION PHOENIX)
Lead Sponsor:
The Medicines Company
Conditions:
Atherosclerosis
Percutaneous Coronary Intervention
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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).
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
11145 Patients enrolled
Trial Details
Trial ID
NCT01156571
Start Date
September 1 2010
End Date
December 1 2012
Last Update
February 4 2014
Active Locations (1)
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1
Anderson Area Medical Center
Anderson, South Carolina, United States, 29621