A Study To Determine the Efficacy and Safety of REG1 Compared to Bivalirudin in Patients Undergoing PCI

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.

Conditions

• Coronary Artery Disease

Interventions

DRUG

pegnivacogin/anivamersen

DRUG

Bivalirudin

Sponsors & Collaborators

• The Cleveland Clinic

  collaborator OTHER

• Duke Clinical Research Institute

  collaborator OTHER

• Canadian VIGOUR Centre

  collaborator OTHER

• Icahn School of Medicine at Mount Sinai

  collaborator OTHER

• Parexel

  collaborator INDUSTRY

• Regado Biosciences, Inc.

  lead INDUSTRY

Principal Investigators

• Steven L Zelenkofske, DO, FACC · Regado Biosciences

• A. Michael Lincoff, MD · The Cleveland Clinic

• Roxana Mehran, MD · Icahn School of Medicine at Mount Sinai

• John H Alexander, MD, MHS · Duke Clinical Research Institute

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-09-30

Primary Completion

2014-08-31

Completion

2014-08-31

Countries

• United States

Study Locations