A Study To Determine the Efficacy and Safety of REG1 Compared to Bivalirudin in Patients Undergoing PCI
Status:
Terminated
Trial end date:
2014-08-01
Target enrollment:
Participant gender:
Summary
This study is designed to determine the efficacy of REG1 compared to bivalirudin in
preventing periprocedural ischemic complications and major bleeding in patients undergoing
PCI as a treatment for CAD. Bivalirudin has been studied in patients undergoing PCI in both
ACS (NSTEMI and unstable angina [UA]) and elective PCI. In comparison to UFH, bivalirudin has
shown similar rates of ischemic events while demonstrating a significant reduction in
bleeding and an improved net clinical benefit.
Evidence from previous studies indicates that pegnivacogin represents an extremely potent,
chemically unique anticoagulant that can be reversed by anivamersen across multiple
populations (refer to Section 1.2.2). The question that still remains is whether Factor IX
(FIX) inhibition by pegnivacogin can result in fewer ischemic events than a previously
studied agent while active control with anivamersen can preserve the benefit of reduced
bleeding. The purpose of this study is to evaluate REG1 in an adequately powered definitive
study with an open-label, multi-center, active-controlled, randomized design to answer that
question.
Phase:
Phase 3
Details
Lead Sponsor:
Regado Biosciences, Inc.
Collaborators:
Canadian VIGOUR Centre Duke Clinical Research Institute Icahn School of Medicine at Mount Sinai Parexel The Cleveland Clinic