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

March 1, 2012 updated by: Regado Biosciences, Inc.
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Primary Outcome Bleeding Secondary Outcome Ischemia

Study Type

Interventional

Enrollment (Actual)

640

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 1M9
        • Vancouver Hospital
    • Ontario
      • Hamilton, Ontario, Canada, L8L 2X2
        • Hamilton Health Science
    • Quebec
      • Montreal, Quebec, Canada, H1T 1C8
        • Montreal Heart Institute Research Center
  • France
      • Nantes cedex 2, France, 44277
        • Nouvelles Cliniques Nantaises
  • Germany
      • Bad Nauheim, Germany, 61231
        • Kerckhoff-Klinik GmbH
      • Bad Soden, Germany, 65812
        • Kardiologische Praxis
      • Chemnitz, Germany, 9113
        • MVZ am Kuechwald GmbH Ambulantes Herzzentrum
      • Coburg, Germany, 96450
        • Klinikum Coburg GmbH 2. Med. Klinik Ebene 3 Studienbuero
      • Freiburg, Germany, 79106
        • Universitatsklinikum Freiburg Abt. Innere Medizin III
      • Fulda, Germany, 36043
        • Klinikum Fulda gAG Medizinische Klinik I
      • Halle/ Saale, Germany, 6097
        • Universitaetsklinikum Halle/Saale Klinik für Innere Medizin III
      • Kiel, Germany, 24105
        • Universitätsklinikum Schleswig-Holstein Kiel
      • Ludwigshafen, Germany, 67063
        • Klinikum der Stadt Ludwigshafen am Rhein gGmbH
      • Magdeburg, Germany, 39120
        • Universitaetsklinik Magdeburg Klinik für Kardiologie Angiologie und Pneumologie
      • Merseburg, Germany, 6217
        • Carl-von-Basedow Klinikum
      • Muenchen, Germany, 81377
        • Klinikum der Universitaet Muenchen Großhadern Medizinische Klinik und Poliklinik I der LMU
      • Quedlinburg, Germany, 6484
        • Klinikum Quedlinburg GmbH Klinik fuer Innere Medizin und Kardiologie
  • United States
    • Alabama
      • Huntsville, Alabama, United States, 35801
        • Heart Center Research LLC
    • California
      • Sacramento, California, United States, 95819
        • Mercy Heart & Vascular Institute
      • Sacramento, California, United States, 95819
        • Sutter Medical Center - Sacramento
      • San Diego, California, United States, 92103
        • Scripps Mercy Hospital
    • Florida
      • Clearwater, Florida, United States, 33756
        • Heart & Vascular Institute of Florida
      • Fort Lauderdale, Florida, United States, 33308
        • Jim Moran Heart & Vascular Research Institute
      • Gainsville, Florida, United States, 32610-0277
        • University of Florida-Medicine Cardiology Research
      • Jacksonville, Florida, United States, 32209
        • University of Florida at Jacksonville
    • Georgia
      • Gainesville, Georgia, United States, 30501
        • Northeast Georgia Heart Center
    • Idaho
      • Boise, Idaho, United States, 83712
        • St. Luke's Idaho Cardiology Associates
      • Meridian, Idaho, United States, 83642
        • St. Luke's Idaho Cardiology Associates
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern Memorial Hospital
    • Indiana
      • Indianapolis, Indiana, United States, 46290
        • The Care Group LLC
    • Louisiana
      • Houma, Louisiana, United States, 70360
        • Cardiovascular Institute of the South - Houma
    • Maryland
      • Baltimore, Maryland, United States, 21215
        • Sinai Hospital of Baltimore
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Health Systems
    • New York
      • Buffalo, New York, United States, 14215
        • Buffalo Heart group
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599-7075
        • University of North Carolina - School of Medicine
    • Ohio
      • Cincinnati, Ohio, United States, 45267
        • University of Cincinnati
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania Health System
      • Philadelphia, Pennsylvania, United States, 19140
        • Temple University
    • South Dakota
      • Rapid City, South Dakota, United States, 57701
        • Black Hills Clinical Research Center
    • Texas
      • Cypress, Texas, United States, 77429
        • North Cypress Medical Center
    • Washington
      • Seattle, Washington, United States, 98122
        • Swedish Medical Center - Cardiovascular
      • Spokane, Washington, United States, 99204
        • Heart Clinics Northwest
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53215
        • Aurora Cardiovascular Services

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Chest pain or other ischemic symptoms a minimum of 10 minutes in duration within 72 hours before anticipated cardiac catheterization;

  • At least one of the following criteria are met:

    1. New or presumably new ST-segment depression of at least 1 mm or transient (30 minutes) ST-segment elevation of at least 1 mm in 2 contiguous leads;
    2. Elevated troponin I, T, or creatine phosphokinase-MB isoenzyme level within 24 hours of signing consent as defined by the universal MI definition
    3. Documented coronary artery disease as evidenced on prior angiography, or by prior angioplasty, bypass graft surgery, or myocardial infarction

Exclusion Criteria:

  • Acute ST-segment elevation myocardial infarct
  • Anticipated inability to perform angiography within 24 hours of dosing
  • Evidence of clinical instability
  • Contraindications to anticoagulant use
  • Recent cardiac intervention
  • Clinically abnormal laboratory or test findings during screening
  • Subject is pregnant or lactating

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: REG1-a
Fixed dose of RB006 (anticoagulant) Variable blinded dose of RB007 (control agent)
Drug: REG1
IV form, bolus dose. May be redosed. Control agent given as single re-dose at completion of intervention
EXPERIMENTAL: REG1-b
Fixed dose of RB006 (anticoagulant) Variable blinded dose of RB007 (control agent)
Drug: REG1
IV form, bolus dose. May be redosed. Control agent given as single re-dose at completion of intervention
EXPERIMENTAL: REG1-c
Fixed dose of RB006 (anticoagulant) Variable blinded dose of RB007 (control agent)
Drug: REG1
IV form, bolus dose. May be redosed. Control agent given as single re-dose at completion of intervention
EXPERIMENTAL: REG1-d
Fixed dose of RB006 (anticoagulant) Variable blinded dose of RB007 (control agent)
Drug: REG1
IV form, bolus dose. May be redosed. Control agent given as single re-dose at completion of intervention
ACTIVE_COMPARATOR: Heparin
Heparin per standard of care at the local institution
Drug: Heparin
IV dose per standard of care at the local institution
Other Names:
  • low molecular weight heparin
  • unfractionated heparin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The composite incidence of major and minor bleeding
Time Frame: Through Day 30
Through Day 30

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Regado Biosciences, Inc.

Investigators

  • Principal Investigator: John H Alexander, MD MHS FACC, Duke Clinical Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2009

Primary Completion (ACTUAL)

January 1, 2011

Study Completion (ACTUAL)

January 1, 2011

Study Registration Dates

First Submitted

July 1, 2009

First Submitted That Met QC Criteria

July 2, 2009

First Posted (ESTIMATE)

July 3, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

March 2, 2012

Last Update Submitted That Met QC Criteria

March 1, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REG-CLIN211

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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