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

Primary Purpose

Acute Coronary Syndrome (ACS)

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
REG1
Heparin
Sponsored by
Regado Biosciences, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Coronary Syndrome (ACS) focused on measuring ACS, Acute Coronary Syndrome, Catheterization

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Heart Center Research LLC
  • Mercy Heart & Vascular Institute
  • Sutter Medical Center - Sacramento
  • Scripps Mercy Hospital
  • Heart & Vascular Institute of Florida
  • Jim Moran Heart & Vascular Research Institute
  • University of Florida-Medicine Cardiology Research
  • University of Florida at Jacksonville
  • Northeast Georgia Heart Center
  • St. Luke's Idaho Cardiology Associates
  • St. Luke's Idaho Cardiology Associates
  • Northwestern Memorial Hospital
  • The Care Group LLC
  • Cardiovascular Institute of the South - Houma
  • Sinai Hospital of Baltimore
  • Henry Ford Health Systems
  • Buffalo Heart Group
  • University of North Carolina - School of Medicine
  • University of Cincinnati
  • University of Pennsylvania Health System
  • Temple University
  • Black Hills Clinical Research Center
  • North Cypress Medical Center
  • Swedish Medical Center - Cardiovascular
  • Heart Clinics Northwest
  • Aurora Cardiovascular Services
  • Vancouver Hospital
  • Hamilton Health Science
  • Montreal Heart Institute Research Center
  • Nouvelles Cliniques Nantaises
  • Kerckhoff-Klinik GmbH
  • Kardiologische Praxis
  • MVZ am Kuechwald GmbH Ambulantes Herzzentrum
  • Klinikum Coburg GmbH 2. Med. Klinik Ebene 3 Studienbuero
  • Universitatsklinikum Freiburg Abt. Innere Medizin III
  • Klinikum Fulda gAG Medizinische Klinik I
  • Universitaetsklinikum Halle/Saale Klinik für Innere Medizin III
  • Universitätsklinikum Schleswig-Holstein Kiel
  • Klinikum der Stadt Ludwigshafen am Rhein gGmbH
  • Universitaetsklinik Magdeburg Klinik für Kardiologie Angiologie und Pneumologie
  • Carl-von-Basedow Klinikum
  • Klinikum der Universitaet Muenchen Großhadern Medizinische Klinik und Poliklinik I der LMU
  • Klinikum Quedlinburg GmbH Klinik fuer Innere Medizin und Kardiologie

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Active Comparator

Arm Label

REG1-a

REG1-b

REG1-c

REG1-d

Heparin

Arm Description

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

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

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

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

Heparin per standard of care at the local institution

Outcomes

Primary Outcome Measures

The composite incidence of major and minor bleeding

Secondary Outcome Measures

Full Information

First Posted
July 1, 2009
Last Updated
March 1, 2012
Sponsor
Regado Biosciences, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00932100
Brief Title
A Study Assessing the REG1 Anticoagulation System Compared Heparin in Subjects With Acute Coronary Syndrome
Acronym
RADAR
Official Title
A Study Assessing the REG1 Anticoagulation System Compared Heparin in Subjects With Acute Coronary Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
January 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Regado Biosciences, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Primary Outcome Bleeding Secondary Outcome Ischemia

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Coronary Syndrome (ACS)
Keywords
ACS, Acute Coronary Syndrome, Catheterization

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
640 (Actual)

8. Arms, Groups, and Interventions

Arm Title
REG1-a
Arm Type
Experimental
Arm Description
Fixed dose of RB006 (anticoagulant) Variable blinded dose of RB007 (control agent)
Arm Title
REG1-b
Arm Type
Experimental
Arm Description
Fixed dose of RB006 (anticoagulant) Variable blinded dose of RB007 (control agent)
Arm Title
REG1-c
Arm Type
Experimental
Arm Description
Fixed dose of RB006 (anticoagulant) Variable blinded dose of RB007 (control agent)
Arm Title
REG1-d
Arm Type
Experimental
Arm Description
Fixed dose of RB006 (anticoagulant) Variable blinded dose of RB007 (control agent)
Arm Title
Heparin
Arm Type
Active Comparator
Arm Description
Heparin per standard of care at the local institution
Intervention Type
Drug
Intervention Name(s)
REG1
Intervention Description
IV form, bolus dose. May be redosed. Control agent given as single re-dose at completion of intervention
Intervention Type
Drug
Intervention Name(s)
Heparin
Other Intervention Name(s)
unfractionated heparin, low molecular weight heparin
Intervention Description
IV dose per standard of care at the local institution
Primary Outcome Measure Information:
Title
The composite incidence of major and minor bleeding
Time Frame
Through Day 30

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John H Alexander, MD MHS FACC
Organizational Affiliation
Duke Clinical Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Heart Center Research LLC
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
Mercy Heart & Vascular Institute
City
Sacramento
State/Province
California
ZIP/Postal Code
95819
Country
United States
Facility Name
Sutter Medical Center - Sacramento
City
Sacramento
State/Province
California
ZIP/Postal Code
95819
Country
United States
Facility Name
Scripps Mercy Hospital
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Heart & Vascular Institute of Florida
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33756
Country
United States
Facility Name
Jim Moran Heart & Vascular Research Institute
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33308
Country
United States
Facility Name
University of Florida-Medicine Cardiology Research
City
Gainsville
State/Province
Florida
ZIP/Postal Code
32610-0277
Country
United States
Facility Name
University of Florida at Jacksonville
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32209
Country
United States
Facility Name
Northeast Georgia Heart Center
City
Gainesville
State/Province
Georgia
ZIP/Postal Code
30501
Country
United States
Facility Name
St. Luke's Idaho Cardiology Associates
City
Boise
State/Province
Idaho
ZIP/Postal Code
83712
Country
United States
Facility Name
St. Luke's Idaho Cardiology Associates
City
Meridian
State/Province
Idaho
ZIP/Postal Code
83642
Country
United States
Facility Name
Northwestern Memorial Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
The Care Group LLC
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46290
Country
United States
Facility Name
Cardiovascular Institute of the South - Houma
City
Houma
State/Province
Louisiana
ZIP/Postal Code
70360
Country
United States
Facility Name
Sinai Hospital of Baltimore
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21215
Country
United States
Facility Name
Henry Ford Health Systems
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Buffalo Heart Group
City
Buffalo
State/Province
New York
ZIP/Postal Code
14215
Country
United States
Facility Name
University of North Carolina - School of Medicine
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599-7075
Country
United States
Facility Name
University of Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
Facility Name
University of Pennsylvania Health System
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Temple University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States
Facility Name
Black Hills Clinical Research Center
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57701
Country
United States
Facility Name
North Cypress Medical Center
City
Cypress
State/Province
Texas
ZIP/Postal Code
77429
Country
United States
Facility Name
Swedish Medical Center - Cardiovascular
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122
Country
United States
Facility Name
Heart Clinics Northwest
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
Facility Name
Aurora Cardiovascular Services
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
Country
United States
Facility Name
Vancouver Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1M9
Country
Canada
Facility Name
Hamilton Health Science
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8L 2X2
Country
Canada
Facility Name
Montreal Heart Institute Research Center
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 1C8
Country
Canada
Facility Name
Nouvelles Cliniques Nantaises
City
Nantes cedex 2
ZIP/Postal Code
44277
Country
France
Facility Name
Kerckhoff-Klinik GmbH
City
Bad Nauheim
ZIP/Postal Code
61231
Country
Germany
Facility Name
Kardiologische Praxis
City
Bad Soden
ZIP/Postal Code
65812
Country
Germany
Facility Name
MVZ am Kuechwald GmbH Ambulantes Herzzentrum
City
Chemnitz
ZIP/Postal Code
9113
Country
Germany
Facility Name
Klinikum Coburg GmbH 2. Med. Klinik Ebene 3 Studienbuero
City
Coburg
ZIP/Postal Code
96450
Country
Germany
Facility Name
Universitatsklinikum Freiburg Abt. Innere Medizin III
City
Freiburg
ZIP/Postal Code
79106
Country
Germany
Facility Name
Klinikum Fulda gAG Medizinische Klinik I
City
Fulda
ZIP/Postal Code
36043
Country
Germany
Facility Name
Universitaetsklinikum Halle/Saale Klinik für Innere Medizin III
City
Halle/ Saale
ZIP/Postal Code
6097
Country
Germany
Facility Name
Universitätsklinikum Schleswig-Holstein Kiel
City
Kiel
ZIP/Postal Code
24105
Country
Germany
Facility Name
Klinikum der Stadt Ludwigshafen am Rhein gGmbH
City
Ludwigshafen
ZIP/Postal Code
67063
Country
Germany
Facility Name
Universitaetsklinik Magdeburg Klinik für Kardiologie Angiologie und Pneumologie
City
Magdeburg
ZIP/Postal Code
39120
Country
Germany
Facility Name
Carl-von-Basedow Klinikum
City
Merseburg
ZIP/Postal Code
6217
Country
Germany
Facility Name
Klinikum der Universitaet Muenchen Großhadern Medizinische Klinik und Poliklinik I der LMU
City
Muenchen
ZIP/Postal Code
81377
Country
Germany
Facility Name
Klinikum Quedlinburg GmbH Klinik fuer Innere Medizin und Kardiologie
City
Quedlinburg
ZIP/Postal Code
6484
Country
Germany

12. IPD Sharing Statement

Citations:
Citation
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
Results Reference
result
PubMed Identifier
30957581
Citation
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.
Results Reference
derived
PubMed Identifier
24929350
Citation
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.
Results Reference
derived
PubMed Identifier
21503856
Citation
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.
Results Reference
derived
PubMed Identifier
21315207
Citation
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.
Results Reference
derived

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

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