Acute Coronary Syndrome (ACS) Clinical Trial
— RADAROfficial title:
A Study Assessing the REG1 Anticoagulation System Compared Heparin in Subjects With Acute Coronary Syndrome
Verified date | March 2012 |
Source | Regado Biosciences, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 640 |
Est. completion date | January 2011 |
Est. primary completion date | January 2011 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Canada | Hamilton Health Science | Hamilton | Ontario |
Canada | Montreal Heart Institute Research Center | Montreal | Quebec |
Canada | Vancouver Hospital | Vancouver | British Columbia |
France | Nouvelles Cliniques Nantaises | Nantes cedex 2 | |
Germany | 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 | |
Germany | Klinikum Fulda gAG Medizinische Klinik I | Fulda | |
Germany | Universitaetsklinikum Halle/Saale Klinik für Innere Medizin III | Halle/ Saale | |
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 | Muenchen | |
Germany | Klinikum Quedlinburg GmbH Klinik fuer Innere Medizin und Kardiologie | Quedlinburg | |
United States | Sinai Hospital of Baltimore | Baltimore | Maryland |
United States | St. Luke's Idaho Cardiology Associates | Boise | Idaho |
United States | Buffalo Heart Group | Buffalo | New York |
United States | University of North Carolina - School of Medicine | Chapel Hill | North Carolina |
United States | Northwestern Memorial Hospital | Chicago | Illinois |
United States | University of Cincinnati | Cincinnati | Ohio |
United States | Heart & Vascular Institute of Florida | Clearwater | Florida |
United States | North Cypress Medical Center | Cypress | Texas |
United States | Henry Ford Health Systems | Detroit | Michigan |
United States | Jim Moran Heart & Vascular Research Institute | Fort Lauderdale | Florida |
United States | Northeast Georgia Heart Center | Gainesville | Georgia |
United States | University of Florida-Medicine Cardiology Research | Gainsville | Florida |
United States | Cardiovascular Institute of the South - Houma | Houma | Louisiana |
United States | Heart Center Research LLC | Huntsville | Alabama |
United States | The Care Group LLC | Indianapolis | Indiana |
United States | University of Florida at Jacksonville | Jacksonville | Florida |
United States | St. Luke's Idaho Cardiology Associates | Meridian | Idaho |
United States | Aurora Cardiovascular Services | Milwaukee | Wisconsin |
United States | Temple University | Philadelphia | Pennsylvania |
United States | University of Pennsylvania Health System | Philadelphia | Pennsylvania |
United States | Black Hills Clinical Research Center | Rapid City | South Dakota |
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 | Swedish Medical Center - Cardiovascular | Seattle | Washington |
United States | Heart Clinics Northwest | Spokane | Washington |
Lead Sponsor | Collaborator |
---|---|
Regado Biosciences, Inc. |
United States, Canada, France, Germany,
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
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The composite incidence of major and minor bleeding | Through Day 30 |
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