This is a multi-center, randomized, double-blind, triple-dummy, clopidogrel-controlled study of IV and oral PRT060128 compared to clopidogrel in patients undergoing non-urgent (including elective) PCI. After diagnostic angiography, patients scheduled for non-urgent PCI will be randomized to clopidogrel or to one of three dose levels of PRT060128.
Each patient randomized in this trial will participate for approximately 12-24 weeks, including a Screening period of up to 2 weeks, the acute peri-procedural phase, and a 60-120 day chronic treatment phase. The chronic phase includes daily in-hospital assessments until 24 Hours or Discharge (whichever comes first), a telephone follow-up on Day 7-10 post-Discharge, outpatient follow-up visits on Days 30 and 60-67, \[Day 90 and Day 120 (if treated for 120 days)\] and a telephone follow-up 7 days following the last dose of study drug.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
652
Loading dose of 300mg or 600mg, followed by once daily dosing of 75 mg
80-120 mg IV bolus administered prior to PCI, followed by twice daily dosing of oral 50mg, 100mg or 150mg
The study is not powered to examine a pre-specified endpoint; rather it is designed to explore a number of analyses to understand the clinical efficacy, biological activity, and tolerability and safety of PRT060128 in patients undergoing non-urgent PCI
Time frame: 24 Hours/Discharge and Day 60
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Portola Investigational Site
La Jolla, California, United States
Portola Investigational Site
Torrance, California, United States
Portola Investigational Site
Washington D.C., District of Columbia, United States
Portola Investigational Site
Jacksonville, Florida, United States
Portola Investigational Site
Tallahassee, Florida, United States
Portola Investigational Site
Augusta, Georgia, United States
Portola Investigational Site
Lexington, Kentucky, United States
Portola Investigational Site
New Orleans, Louisiana, United States
Portola Investigational Site
Portland, Maine, United States
Portola Investigational Site
Baltimore, Maryland, United States
...and 49 more locations