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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

July 1, 2009
March 1, 2012
July 2009
January 2011   (final data collection date for primary outcome measure)
The composite incidence of major and minor bleeding [ Time Frame: Through Day 30 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00932100 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
A Study Assessing the REG1 Anticoagulation System Compared Heparin in Subjects With Acute Coronary Syndrome
A Study Assessing the REG1 Anticoagulation System Compared Heparin in Subjects With Acute Coronary Syndrome

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.

Primary Outcome Bleeding Secondary Outcome Ischemia

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Acute Coronary Syndrome (ACS)
  • Drug: REG1
    IV form, bolus dose. May be redosed. Control agent given as single re-dose at completion of intervention
  • Drug: Heparin
    IV dose per standard of care at the local institution
    Other Names:
    • unfractionated heparin
    • low molecular weight heparin
  • Experimental: REG1-a
    Fixed dose of RB006 (anticoagulant) Variable blinded dose of RB007 (control agent)
    Intervention: Drug: REG1
  • Experimental: REG1-b
    Fixed dose of RB006 (anticoagulant) Variable blinded dose of RB007 (control agent)
    Intervention: Drug: REG1
  • Experimental: REG1-c
    Fixed dose of RB006 (anticoagulant) Variable blinded dose of RB007 (control agent)
    Intervention: Drug: REG1
  • Experimental: REG1-d
    Fixed dose of RB006 (anticoagulant) Variable blinded dose of RB007 (control agent)
    Intervention: Drug: REG1
  • Active Comparator: Heparin
    Heparin per standard of care at the local institution
    Intervention: Drug: Heparin

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
640
January 2011
January 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada,   France,   Germany
 
NCT00932100
REG-CLIN211
Yes
Regado Biosciences, Inc.
Regado Biosciences, Inc.
Not Provided
Principal Investigator: John H Alexander, MD MHS FACC Duke Clinical Research Institute
Regado Biosciences, Inc.
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP