A Study Assessing the REG1 Anticoagulation System Compared Heparin in Subjects With Acute Coronary Syndrome
RADAR
1 other identifier
interventional
640
4 countries
43
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jul 2009
Shorter than P25 for phase_2
43 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 1, 2009
CompletedStudy Start
First participant enrolled
July 1, 2009
CompletedFirst Posted
Study publicly available on registry
July 3, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2011
CompletedMarch 2, 2012
March 1, 2012
1.5 years
July 1, 2009
March 1, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The composite incidence of major and minor bleeding
Through Day 30
Study Arms (5)
REG1-a
EXPERIMENTALFixed dose of RB006 (anticoagulant) Variable blinded dose of RB007 (control agent)
REG1-b
EXPERIMENTALFixed dose of RB006 (anticoagulant) Variable blinded dose of RB007 (control agent)
REG1-c
EXPERIMENTALFixed dose of RB006 (anticoagulant) Variable blinded dose of RB007 (control agent)
REG1-d
EXPERIMENTALFixed dose of RB006 (anticoagulant) Variable blinded dose of RB007 (control agent)
Heparin
ACTIVE COMPARATORHeparin per standard of care at the local institution
Interventions
Eligibility Criteria
You may qualify if:
- 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:
- 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;
- Elevated troponin I, T, or creatine phosphokinase-MB isoenzyme level within 24 hours of signing consent as defined by the universal MI definition
- Documented coronary artery disease as evidenced on prior angiography, or by prior angioplasty, bypass graft surgery, or myocardial infarction
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (43)
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, 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 im Breisgau, 79106, Germany
Klinikum Fulda gAG Medizinische Klinik I
Fulda, 36043, Germany
Universitaetsklinikum Halle/Saale Klinik für Innere Medizin III
Halle, 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
München, 81377, Germany
Klinikum Quedlinburg GmbH Klinik fuer Innere Medizin und Kardiologie
Quedlinburg, 6484, Germany
Related Publications (5)
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
RESULTPark 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.
PMID: 30957581DERIVEDPovsic 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.
PMID: 24929350DERIVEDPovsic 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.
PMID: 21503856DERIVEDPovsic 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.
PMID: 21315207DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
John H Alexander, MD MHS FACC
Duke Clinical Research Institute
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 1, 2009
First Posted
July 3, 2009
Study Start
July 1, 2009
Primary Completion
January 1, 2011
Study Completion
January 1, 2011
Last Updated
March 2, 2012
Record last verified: 2012-03