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

Acute Coronary Syndrome (ACS) Clinical Trial

— RADAR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00932100
• Other study ID #: REG-CLIN211
• Status: Completed
• Phase: Phase 2
• First received: July 1, 2009
• Last updated: March 1, 2012
• Start date: July 2009
• Est. completion date: January 2011

Study information

• Verified date: March 2012
• Source: Regado Biosciences, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Primary Outcome Bleeding Secondary Outcome Ischemia

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Acute Coronary Syndrome (ACS)
• Syndrome

Intervention

Drug:
• 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

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Regado Biosciences, Inc.

Countries where clinical trial is conducted

United States,  Canada,  France,  Germany, 

References & Publications (1)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The composite incidence of major and minor bleeding		Through Day 30