Phase 3
Completed N=11,145
A Clinical Trial Comparing Cangrelor to Clopidogrel Standard Therapy in Subjects Who Require Percutaneous Coronary Intervention (PCI) (CHAMPION PHOENIX)
Source: ClinicalTrials.gov NCT01156571 ↗Enrolled (actual)
11,145
Serious AEs
2.1%
Results posted
Jun 2013
Primary outcomePrimary: The Composite Incidence of All-cause Mortality, Myocardial Infarction (MI), Ischemia-driven Revascularization (IDR) and Stent Thrombosis (ST) — 257; 322 participants
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Composite Incidence of All-cause Mortality, Myocardial Infarction (MI), Ischemia-driven Revascularization (IDR) and Stent Thrombosis (ST) |
257; 322 | — |
| SECONDARY Individual Incidence of Stent Thrombosis (ST), Death, Myocardial Infarction (MI) and Ischemia-driven Revascularization (IDR) |
46; 74; 18; 18; 207; 255 | — |
| SECONDARY Incidence of Major/Minor Non-coronary Artery Bypass Graft (CABG)-Related Hemorrhage by Clinical Relevant Criteria - GUSTO Severe/Life-threatening, Moderate and Mild |
9; 6; 22; 13; 31; 19 | — |
Eligibility 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):
- 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
Data sourced from ClinicalTrials.gov (NCT01156571). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.