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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Show 43 Study Locations
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 August 18, 2014