Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01156571 | A Clinical Trial Comparing Cangrelor to Clopidogrel Standard Therapy in Subjects Who Require Percutaneous Coronary Intervention (PCI) (CHAMPION PHOENIX) | PHASE3 | COMPLETED | 11,145 | — | — | Sep 1, 2010 | Dec 1, 2012 | Feb 4, 2014 | 1 | United States |
Clinical Events Committee (CEC)-adjudicated results (modified intent-to-treat \[mITT\] population)
| Arm | Type | Description |
|---|---|---|
| cangrelor | EXPERIMENTAL | 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. |
| clopidogrel | ACTIVE_COMPARATOR | 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. |
| Name | Type | Description |
|---|---|---|
| cangrelor P2Y12 (platelet) inhibitor | DRUG | - |
| Clopidogrel - 300 or 600 mg (study arm) | DRUG | Over encapsulated tablets. |
| Clopidogrel 600 mg post cangrelor | DRUG | over-encapsulated clopidogrel (600 mg) |
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...