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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00932100
Recruitment Status : Completed
First Posted : July 3, 2009
Last Update Posted : March 2, 2012
Sponsor:
Information provided by (Responsible Party):
Regado Biosciences, Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Acute Coronary Syndrome (ACS) Drug: REG1 Drug: Heparin Phase 2

Detailed Description:
Primary Outcome Bleeding Secondary Outcome Ischemia
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 640 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Study Assessing the REG1 Anticoagulation System Compared Heparin in Subjects With Acute Coronary Syndrome
Study Start Date : July 2009
Actual Primary Completion Date : January 2011
Actual Study Completion Date : January 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Thinners

Arms and Interventions
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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:
  • unfractionated heparin
  • low molecular weight heparin


Outcome Measures
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Primary Outcome Measures :
  1. The composite incidence of major and minor bleeding [ Time Frame: Through Day 30 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00932100


Locations
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Sponsors and Collaborators
Regado Biosciences, Inc.
Investigators
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Principal Investigator: John H Alexander, MD MHS FACC Duke Clinical Research Institute
More Information
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Publications of Results:
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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Regado Biosciences, Inc.
ClinicalTrials.gov Identifier: NCT00932100    
Other Study ID Numbers: REG-CLIN211
First Posted: July 3, 2009    Key Record Dates
Last Update Posted: March 2, 2012
Last Verified: March 2012
Keywords provided by Regado Biosciences, Inc.:
ACS
Acute Coronary Syndrome
Catheterization
Additional relevant MeSH terms:
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Acute Coronary Syndrome
Syndrome
Disease
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Heparin
 Calcium heparin
Heparin, Low-Molecular-Weight
Tinzaparin
Dalteparin
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action