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CompletedNCT00932100RADARUpdated Mar 2, 2012

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

A Phase 2 interventional study of REG1 and Heparin in Acute Coronary Syndrome (ACS), sponsored by Regado Biosciences, Inc.. Completed at 43 sites in 4 countries. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2012-03-02.

Sponsored by Regado Biosciences, Inc. · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
640
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

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.

Read the detailed description

Primary Outcome Bleeding Secondary Outcome Ischemia

02

Conditions studied

  • Acute Coronary Syndrome (ACS)

Keywords

  • ACS
  • Acute Coronary Syndrome
  • Catheterization
03

In context

Acute Coronary Syndrome

1,461 studies on the registry are indexed under Acute Coronary Syndrome; 267 are open to participants now.

This study's enrollment of 640 is above the median of 200 across 869 interventional studies indexed under Acute Coronary Syndrome.

Browse Acute Coronary Syndrome studies →

Lead sponsor

Regado Biosciences, Inc. is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
640 participants (actual)

Study arms

  • Experimental
    REG1-a

    Fixed dose of RB006 (anticoagulant) Variable blinded dose of RB007 (control agent)

    Drug: REG1

  • Experimental
    REG1-b

    Fixed dose of RB006 (anticoagulant) Variable blinded dose of RB007 (control agent)

    Drug: REG1

  • Experimental
    REG1-c

    Fixed dose of RB006 (anticoagulant) Variable blinded dose of RB007 (control agent)

    Drug: REG1

  • Experimental
    REG1-d

    Fixed dose of RB006 (anticoagulant) Variable blinded dose of RB007 (control agent)

    Drug: REG1

  • Active comparator
    Heparin

    Heparin per standard of care at the local institution

    Drug: Heparin

Interventions

  • DrugREG1

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

  • DrugHeparin

    IV dose per standard of care at the local institution

    Also known as: unfractionated heparin, low molecular weight heparin

06

What researchers measure

Primary outcomes

  1. The composite incidence of major and minor bleeding

    Time frame: Through Day 30

07

Study locations

43 sites
  • Heart Center Research LLC
    Huntsville, Alabama 35801, United States
  • Mercy Heart & Vascular Institute
    Sacramento, California 95819, United States
  • Sutter Medical Center - Sacramento
    Sacramento, California 95819, United States
  • Scripps Mercy Hospital
    San Diego, California 92103, United States
  • Heart & Vascular Institute of Florida
    Clearwater, Florida 33756, United States
  • Jim Moran Heart & Vascular Research Institute
    Fort Lauderdale, Florida 33308, United States
  • University of Florida-Medicine Cardiology Research
    Gainsville, Florida 32610-0277, United States
  • University of Florida at Jacksonville
    Jacksonville, Florida 32209, United States
  • Northeast Georgia Heart Center
    Gainesville, Georgia 30501, United States
  • St. Luke's Idaho Cardiology Associates
    Boise, Idaho 83712, United States
  • St. Luke's Idaho Cardiology Associates
    Meridian, Idaho 83642, United States
  • Northwestern Memorial Hospital
    Chicago, Illinois 60611, United States
  • The Care Group LLC
    Indianapolis, Indiana 46290, United States
  • Cardiovascular Institute of the South - Houma
    Houma, Louisiana 70360, United States
  • Sinai Hospital of Baltimore
    Baltimore, Maryland 21215, United States
  • Henry Ford Health Systems
    Detroit, Michigan 48202, United States
  • Buffalo Heart Group
    Buffalo, New York 14215, United States
  • University of North Carolina - School of Medicine
    Chapel Hill, North Carolina 27599-7075, United States
  • University of Cincinnati
    Cincinnati, Ohio 45267, United States
  • University of Pennsylvania Health System
    Philadelphia, Pennsylvania 19104, United States
  • Temple University
    Philadelphia, Pennsylvania 19140, United States
  • Black Hills Clinical Research Center
    Rapid City, South Dakota 57701, United States
  • North Cypress Medical Center
    Cypress, Texas 77429, United States
  • Swedish Medical Center - Cardiovascular
    Seattle, Washington 98122, United States
  • Heart Clinics Northwest
    Spokane, Washington 99204, United States
  • Aurora Cardiovascular Services
    Milwaukee, Wisconsin 53215, United States
  • Vancouver Hospital
    Vancouver, British Columbia V5Z 1M9, Canada
  • Hamilton Health Science
    Hamilton, Ontario L8L 2X2, Canada
  • Montreal Heart Institute Research Center
    Montreal, Quebec H1T 1C8, Canada
  • Nouvelles Cliniques Nantaises
    Nantes cedex 2, 44277, France
  • Kerckhoff-Klinik GmbH
    Bad Nauheim, 61231, Germany
  • Kardiologische Praxis
    Bad Soden, 65812, Germany
  • MVZ am Kuechwald GmbH Ambulantes Herzzentrum
    Chemnitz, 9113, Germany
  • Klinikum Coburg GmbH 2. Med. Klinik Ebene 3 Studienbuero
    Coburg, 96450, Germany
  • Universitatsklinikum Freiburg Abt. Innere Medizin III
    Freiburg, 79106, Germany
  • Klinikum Fulda gAG Medizinische Klinik I
    Fulda, 36043, Germany
  • Universitaetsklinikum Halle/Saale Klinik für Innere Medizin III
    Halle/ Saale, 6097, Germany
  • Universitätsklinikum Schleswig-Holstein Kiel
    Kiel, 24105, Germany
  • Klinikum der Stadt Ludwigshafen am Rhein gGmbH
    Ludwigshafen, 67063, Germany
  • Universitaetsklinik Magdeburg Klinik für Kardiologie Angiologie und Pneumologie
    Magdeburg, 39120, Germany
  • Carl-von-Basedow Klinikum
    Merseburg, 6217, Germany
  • Klinikum der Universitaet Muenchen Großhadern Medizinische Klinik und Poliklinik I der LMU
    Muenchen, 81377, Germany
  • Klinikum Quedlinburg GmbH Klinik fuer Innere Medizin und Kardiologie
    Quedlinburg, 6484, Germany
08

References and documents

Publications

  • TCT-176: Access and non-Access Site Bleeding in Acute Coronary Syndrome Patients Treated with a Novel Actively Reversible Factor IXa Inhibitor. Results from the RADAR Trial J Am Coll Cardiol 2011 58: B47
  • Park EJ, Choi J, Lee KC, Na DH. Emerging PEGylated non-biologic drugs. Expert Opin Emerg Drugs. 2019 Jun;24(2):107-119. doi: 10.1080/14728214.2019.1604684. Epub 2019 Apr 19. PubMed 30957581 ↗
  • Povsic TJ, Vavalle JP, Alexander JH, Aberle LH, Zelenkofske SL, Becker RC, Buller CE, Cohen MG, Cornel JH, Kasprzak JD, Montalescot G, Fail PS, Sarembock IJ, Mehran R; RADAR Investigators. Use of the REG1 anticoagulation system in patients with acute coronary syndromes undergoing percutaneous coronary intervention: results from the phase II RADAR-PCI study. EuroIntervention. 2014 Aug;10(4):431-8. doi: 10.4244/EIJY14M06_01. PubMed 24929350 ↗
  • Povsic TJ, Cohen MG, Chan MY, Zelenkofske SL, Wargin WA, Harrington RA, Alexander JH, Rusconi CP, Becker RC. Dose selection for a direct and selective factor IXa inhibitor and its complementary reversal agent: translating pharmacokinetic and pharmacodynamic properties of the REG1 system to clinical trial design. J Thromb Thrombolysis. 2011 Jul;32(1):21-31. doi: 10.1007/s11239-011-0588-3. PubMed 21503856 ↗
  • Povsic TJ, Cohen MG, Mehran R, Buller CE, Bode C, Cornel JH, Kasprzak JD, Montalescot G, Joseph D, Wargin WA, Rusconi CP, Zelenkofske SL, Becker RC, Alexander JH. A randomized, partially blinded, multicenter, active-controlled, dose-ranging study assessing the safety, efficacy, and pharmacodynamics of the REG1 anticoagulation system in patients with acute coronary syndromes: design and rationale of the RADAR Phase IIb trial. Am Heart J. 2011 Feb;161(2):261-268.e1-2. doi: 10.1016/j.ahj.2010.10.022. PubMed 21315207 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 2, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00932100
Lead sponsor
Regado Biosciences, Inc.
Responsible party
Sponsor
First posted
Jul 3, 2009
Start date
Jul 2009
Primary completion
Jan 2011
Completion
Jan 2011
Last update
Mar 2, 2012

Study contacts

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

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2012. You cannot join it, but the record below documents what was studied.

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