A Study Assessing the REG1 Anticoagulation System Compared Heparin in Subjects With Acute Coronary Syndrome
NCT ID: NCT00932100
Last Updated: 2012-03-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
640 participants
INTERVENTIONAL
2009-07-31
2011-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study To Determine the Efficacy and Safety of REG1 Compared to Bivalirudin in Patients Undergoing PCI
NCT01848106
Feasibility and Safety Study Comparing REG1 Anticoagulation System With Unfractionated Heparin in Elective PCI
NCT00715455
Outcome of Longterm Antithrombotic Therapy in Acute Coronary Syndrome Patients
NCT01623700
Safety and Efficacy of CMX-2043 for Protection of the Heart and Kidneys in Subjects Undergoing Coronary Angiography
NCT02103959
A Study of RTP-026 to Assess Safety, Tolerability and Efficacy in Patients With ST-Elevation Myocardial Infarction (STEMI)
NCT06465303
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
REG1-a
Fixed dose of RB006 (anticoagulant) Variable blinded dose of RB007 (control agent)
REG1
IV form, bolus dose. May be redosed. Control agent given as single re-dose at completion of intervention
REG1-b
Fixed dose of RB006 (anticoagulant) Variable blinded dose of RB007 (control agent)
REG1
IV form, bolus dose. May be redosed. Control agent given as single re-dose at completion of intervention
REG1-c
Fixed dose of RB006 (anticoagulant) Variable blinded dose of RB007 (control agent)
REG1
IV form, bolus dose. May be redosed. Control agent given as single re-dose at completion of intervention
REG1-d
Fixed dose of RB006 (anticoagulant) Variable blinded dose of RB007 (control agent)
REG1
IV form, bolus dose. May be redosed. Control agent given as single re-dose at completion of intervention
Heparin
Heparin per standard of care at the local institution
Heparin
IV dose per standard of care at the local institution
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
REG1
IV form, bolus dose. May be redosed. Control agent given as single re-dose at completion of intervention
Heparin
IV dose per standard of care at the local institution
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
80 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Regado Biosciences, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
John H Alexander, MD MHS FACC
Role: PRINCIPAL_INVESTIGATOR
Duke Clinical Research Institute
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Heart Center Research LLC
Huntsville, Alabama, United States
Mercy Heart & Vascular Institute
Sacramento, California, United States
Sutter Medical Center - Sacramento
Sacramento, California, United States
Scripps Mercy Hospital
San Diego, California, United States
Heart & Vascular Institute of Florida
Clearwater, Florida, United States
Jim Moran Heart & Vascular Research Institute
Fort Lauderdale, Florida, United States
University of Florida-Medicine Cardiology Research
Gainsville, Florida, United States
University of Florida at Jacksonville
Jacksonville, Florida, United States
Northeast Georgia Heart Center
Gainesville, Georgia, United States
St. Luke's Idaho Cardiology Associates
Boise, Idaho, United States
St. Luke's Idaho Cardiology Associates
Meridian, Idaho, United States
Northwestern Memorial Hospital
Chicago, Illinois, United States
The Care Group LLC
Indianapolis, Indiana, United States
Cardiovascular Institute of the South - Houma
Houma, Louisiana, United States
Sinai Hospital of Baltimore
Baltimore, Maryland, United States
Henry Ford Health Systems
Detroit, Michigan, United States
Buffalo Heart Group
Buffalo, New York, United States
University of North Carolina - School of Medicine
Chapel Hill, North Carolina, United States
University of Cincinnati
Cincinnati, Ohio, United States
University of Pennsylvania Health System
Philadelphia, Pennsylvania, United States
Temple University
Philadelphia, Pennsylvania, United States
Black Hills Clinical Research Center
Rapid City, South Dakota, United States
North Cypress Medical Center
Cypress, Texas, United States
Swedish Medical Center - Cardiovascular
Seattle, Washington, United States
Heart Clinics Northwest
Spokane, Washington, United States
Aurora Cardiovascular Services
Milwaukee, Wisconsin, United States
Vancouver Hospital
Vancouver, British Columbia, Canada
Hamilton Health Science
Hamilton, Ontario, Canada
Montreal Heart Institute Research Center
Montreal, Quebec, Canada
Nouvelles Cliniques Nantaises
Nantes, , France
Kerckhoff-Klinik GmbH
Bad Nauheim, , Germany
Kardiologische Praxis
Bad Soden, , Germany
MVZ am Kuechwald GmbH Ambulantes Herzzentrum
Chemnitz, , Germany
Klinikum Coburg GmbH 2. Med. Klinik Ebene 3 Studienbuero
Coburg, , Germany
Universitatsklinikum Freiburg Abt. Innere Medizin III
Freiburg im Breisgau, , Germany
Klinikum Fulda gAG Medizinische Klinik I
Fulda, , Germany
Universitaetsklinikum Halle/Saale Klinik für Innere Medizin III
Halle, , Germany
Universitätsklinikum Schleswig-Holstein Kiel
Kiel, , Germany
Klinikum der Stadt Ludwigshafen am Rhein gGmbH
Ludwigshafen, , Germany
Universitaetsklinik Magdeburg Klinik für Kardiologie Angiologie und Pneumologie
Magdeburg, , Germany
Carl-von-Basedow Klinikum
Merseburg, , Germany
Klinikum der Universitaet Muenchen Großhadern Medizinische Klinik und Poliklinik I der LMU
München, , Germany
Klinikum Quedlinburg GmbH Klinik fuer Innere Medizin und Kardiologie
Quedlinburg, , Germany
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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
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.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
REG-CLIN211
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.