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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Regado Biosciences, Inc.
ClinicalTrials.gov Identifier:
NCT00932100
First received: July 1, 2009
Last updated: March 1, 2012
Last verified: March 2012
  Purpose

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.


Condition Intervention Phase
Acute Coronary Syndrome (ACS)
Drug: REG1
Drug: Heparin
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Study Assessing the REG1 Anticoagulation System Compared Heparin in Subjects With Acute Coronary Syndrome

Resource links provided by NLM:


Further study details as provided by Regado Biosciences, Inc.:

Primary Outcome Measures:
  • The composite incidence of major and minor bleeding [ Time Frame: Through Day 30 ] [ Designated as safety issue: Yes ]

Enrollment: 640
Study Start Date: July 2009
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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:
  • unfractionated heparin
  • low molecular weight heparin

Detailed Description:

Primary Outcome Bleeding Secondary Outcome Ischemia

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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:

    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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00932100

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

No publications provided by Regado Biosciences, Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Regado Biosciences, Inc.
ClinicalTrials.gov Identifier: NCT00932100     History of Changes
Other Study ID Numbers: REG-CLIN211
Study First Received: July 1, 2009
Last Updated: March 1, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Regado Biosciences, Inc.:
ACS
Acute Coronary Syndrome
Catheterization

Additional relevant MeSH terms:
Acute Coronary Syndrome
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Angina Pectoris
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms
Calcium heparin
Heparin
Heparin, Low-Molecular-Weight
Dalteparin
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on April 14, 2014