Clinical trial NCT00932100: A Study Assessing the REG1 Anticoagulation System Compared Heparin in Subjects With Acute Coronary Syndrome
Official title: A Study Assessing the REG1 Anticoagulation System Compared Heparin in Subjects With Acute Coronary Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acute Coronary Syndrome (ACS)
Keywords: ACS
Acute Coronary Syndrome
Catheterization
Lead sponsor: Regado Biosciences, Inc.
Sponsor class: INDUSTRY
First posted: 2009-07-03
Enrollment: 640
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: Primary Outcome Bleeding Secondary Outcome Ischemia

Eligibility 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

Primary outcomes:
measure: The composite incidence of major and minor bleeding
timeFrame: Through Day 30
Secondary outcomes:
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Heart Center Research LLC
state: Alabama
city: Sacramento
country: United States
facility: Mercy Heart & Vascular Institute
state: California
city: Sacramento
country: United States
facility: Sutter Medical Center - Sacramento
state: California
city: San Diego
country: United States
facility: Scripps Mercy Hospital
state: California
city: Clearwater
country: United States
facility: Heart & Vascular Institute of Florida
state: Florida
city: Fort Lauderdale
country: United States
facility: Jim Moran Heart & Vascular Research Institute
state: Florida
city: Gainsville
country: United States
facility: University of Florida-Medicine Cardiology Research
state: Florida
city: Jacksonville
country: United States
facility: University of Florida at Jacksonville
state: Florida
city: Gainesville
country: United States
facility: Northeast Georgia Heart Center
state: Georgia
city: Boise
country: United States
facility: St. Luke's Idaho Cardiology Associates
state: Idaho
city: Meridian
country: United States
facility: St. Luke's Idaho Cardiology Associates
state: Idaho
city: Chicago
country: United States
facility: Northwestern Memorial Hospital
state: Illinois
city: Indianapolis
country: United States
facility: The Care Group LLC
state: Indiana
city: Houma
country: United States
facility: Cardiovascular Institute of the South - Houma
state: Louisiana
city: Baltimore
country: United States
facility: Sinai Hospital of Baltimore
state: Maryland
city: Detroit
country: United States
facility: Henry Ford Health Systems
state: Michigan
city: Buffalo
country: United States
facility: Buffalo Heart Group
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina - School of Medicine
state: North Carolina
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
city: Philadelphia
country: United States
facility: University of Pennsylvania Health System
state: Pennsylvania
city: Philadelphia
country: United States
facility: Temple University
state: Pennsylvania
city: Rapid City
country: United States
facility: Black Hills Clinical Research Center
state: South Dakota
city: Cypress
country: United States
facility: North Cypress Medical Center
state: Texas
city: Seattle
country: United States
facility: Swedish Medical Center - Cardiovascular
state: Washington
city: Spokane
country: United States
facility: Heart Clinics Northwest
state: Washington
city: Milwaukee
country: United States
facility: Aurora Cardiovascular Services
state: Wisconsin
city: Vancouver
country: Canada
facility: Vancouver Hospital
state: British Columbia
city: Hamilton
country: Canada
facility: Hamilton Health Science
state: Ontario
city: Montreal
country: Canada
facility: Montreal Heart Institute Research Center
state: Quebec
city: Nantes cedex 2
country: France
facility: Nouvelles Cliniques Nantaises
city: Bad Nauheim
country: Germany
facility: Kerckhoff-Klinik GmbH
city: Bad Soden
country: Germany
facility: Kardiologische Praxis
city: Chemnitz
country: Germany
facility: MVZ am Kuechwald GmbH Ambulantes Herzzentrum
city: Coburg
country: Germany
facility: Klinikum Coburg GmbH 2. Med. Klinik Ebene 3 Studienbuero
city: Freiburg
country: Germany
facility: Universitatsklinikum Freiburg Abt. Innere Medizin III
city: Fulda
country: Germany
facility: Klinikum Fulda gAG Medizinische Klinik I
city: Halle/ Saale
country: Germany
facility: Universitaetsklinikum Halle/Saale Klinik fÃ¼r Innere Medizin III
city: Kiel
country: Germany
facility: UniversitÃ¤tsklinikum Schleswig-Holstein Kiel
city: Ludwigshafen
country: Germany
facility: Klinikum der Stadt Ludwigshafen am Rhein gGmbH
city: Magdeburg
country: Germany
facility: Universitaetsklinik Magdeburg Klinik fÃ¼r Kardiologie Angiologie und Pneumologie
city: Merseburg
country: Germany
facility: Carl-von-Basedow Klinikum
city: Muenchen
country: Germany
facility: Klinikum der Universitaet Muenchen GroÃŸhadern Medizinische Klinik und Poliklinik I der LMU
city: Quedlinburg
country: Germany
facility: Klinikum Quedlinburg GmbH Klinik fuer Innere Medizin und Kardiologie
Study officials:
affiliation: Duke Clinical Research Institute
name: John H Alexander, MD MHS FACC
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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
citation: 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.
citation: 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.
citation: 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.
citation: 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.