NCT00751231

A Phase 2 Safety and Efficacy Study of PRT060128, a Novel Intravenous and Oral P2Y12 Inhibitor, in Non-Urgent PCI

A Randomized, Double-Blind, Active-Controlled Trial to Evaluate Intravenous and Oral PRT060128, a Selective and Reversible P2Y12 Inhibitor, vs Clopidogrel, as a Novel Antiplatelet Therapy in Patients Undergoing Non-Urgent PCI

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 652 (actual)
• Sponsor: Portola Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Percutaneous Coronary Intervention

Interventions

Type	Name	Description
DRUG	clopidogrel	Loading dose of 300mg or 600mg, followed by once daily dosing of 75 mg
DRUG	PRT060128	80-120 mg IV bolus administered prior to PCI, followed by twice daily dosing of oral 50mg, 100mg or 150mg

Timeline

• Start date: 2008-12-01
• Primary completion: 2010-04-01
• Completion: 2010-04-01
• First posted: 2008-09-11
• Last updated: 2023-08-08

Locations

59 sites across 5 countries: United States, Austria, Canada, Germany, Poland