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A Study Assessing the REG1 Anticoagulation System Compared Heparin in Subjects With Acute Coronary Syndrome

NCT00932100 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 640

Last updated 2012-03-02

No results posted yet for this study

Summary

The purpose of this study is to evaluate the safety and efficacy of the REG1 anticoagulation System in Acute Coronary Syndrome (ACS) patients undergoing cardiac catheterization.

Conditions

  • Acute Coronary Syndrome (ACS)

Interventions

DRUG

REG1

IV form, bolus dose. May be redosed. Control agent given as single re-dose at completion of intervention

DRUG

Heparin

IV dose per standard of care at the local institution

Sponsors & Collaborators

  • Regado Biosciences, Inc.

    lead INDUSTRY

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-07-31
Primary Completion
2011-01-31
Completion
2011-01-31

Countries

  • United States
  • Canada
  • France
  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00932100 on ClinicalTrials.gov