A Clinical Trial Comparing Cangrelor to Clopidogrel Standard Therapy in Subjects Who Require Percutaneous Coronary Intervention (PCI) (CHAMPION PHOENIX)
Status: | Recruiting |
---|---|
Conditions: | Peripheral Vascular Disease, Cardiology |
Therapuetic Areas: | Cardiology / Vascular Diseases |
Healthy: | No |
Age Range: | Any |
Updated: | 11/18/2012 |
Start Date: | September 2010 |
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).
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
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