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

Phase 2

Completed

• Conditions: Acute Coronary Syndrome (ACS)
• Interventions: Drug: REG1; Drug: Heparin

• Registration Number: NCT00932100
• Lead Sponsor: Regado Biosciences, Inc.

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

Study Timeline

• Study Start: 2009-07
• Study First Submitted: 2009-07-01
• Study First Submitted QC: 2009-07-02
• Study First Posted: 2009-07-03
• Primary Completion: 2011-01
• Study Completion: 2011-01
• Status Verified: 2012-03
• Last Update Submitted: 2012-03-01
• Last Update Posted: 2012-03-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 640

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
REG1-b	REG1	Fixed dose of RB006 (anticoagulant) Variable blinded dose of RB007 (control agent)
REG1-c	REG1	Fixed dose of RB006 (anticoagulant) Variable blinded dose of RB007 (control agent)
Heparin	Heparin	Heparin per standard of care at the local institution
REG1-a	REG1	Fixed dose of RB006 (anticoagulant) Variable blinded dose of RB007 (control agent)
REG1-d	REG1	Fixed dose of RB006 (anticoagulant) Variable blinded dose of RB007 (control agent)

Primary Outcome Measures

Name	Time	Method
The composite incidence of major and minor bleeding	Through Day 30

Trial Locations

Locations (42)

Northwestern Memorial Hospital; 🇺🇸 Chicago, Illinois, United States

Sinai Hospital of Baltimore; 🇺🇸 Baltimore, Maryland, United States

Temple University; 🇺🇸 Philadelphia, Pennsylvania, United States

Universitätsklinikum Schleswig-Holstein Kiel; 🇩🇪 Kiel, Germany

Swedish Medical Center - Cardiovascular; 🇺🇸 Seattle, Washington, United States

Hamilton Health Science; 🇨🇦 Hamilton, Ontario, Canada

Heart Center Research LLC; 🇺🇸 Huntsville, Alabama, United States

Mercy Heart & Vascular Institute; 🇺🇸 Sacramento, California, United States

Klinikum Coburg GmbH 2. Med. Klinik Ebene 3 Studienbuero; 🇩🇪 Coburg, Germany

University of Pennsylvania Health System; 🇺🇸 Philadelphia, Pennsylvania, United States

North Cypress Medical Center; 🇺🇸 Cypress, Texas, United States

St. Luke's Idaho Cardiology Associates; 🇺🇸 Meridian, Idaho, United States

Klinikum Fulda gAG Medizinische Klinik I; 🇩🇪 Fulda, Germany

Universitaetsklinikum Halle/Saale Klinik für Innere Medizin III; 🇩🇪 Halle/ Saale, Germany

Montreal Heart Institute Research Center; 🇨🇦 Montreal, Quebec, Canada

MVZ am Kuechwald GmbH Ambulantes Herzzentrum; 🇩🇪 Chemnitz, Germany

Universitatsklinikum Freiburg Abt. Innere Medizin III; 🇩🇪 Freiburg, Germany

Klinikum der Universitaet Muenchen Großhadern Medizinische Klinik und Poliklinik I der LMU; 🇩🇪 Muenchen, Germany

Black Hills Clinical Research Center; 🇺🇸 Rapid City, South Dakota, United States

Vancouver Hospital; 🇨🇦 Vancouver, British Columbia, Canada

Scripps Mercy Hospital; 🇺🇸 San Diego, California, United States

University of Florida-Medicine Cardiology Research; 🇺🇸 Gainsville, Florida, United States

The Care Group LLC; 🇺🇸 Indianapolis, Indiana, United States

University of Cincinnati; 🇺🇸 Cincinnati, Ohio, United States

Aurora Cardiovascular Services; 🇺🇸 Milwaukee, Wisconsin, United States

Universitaetsklinik Magdeburg Klinik für Kardiologie Angiologie und Pneumologie; 🇩🇪 Magdeburg, Germany

Klinikum der Stadt Ludwigshafen am Rhein gGmbH; 🇩🇪 Ludwigshafen, Germany

Carl-von-Basedow Klinikum; 🇩🇪 Merseburg, Germany

Henry Ford Health Systems; 🇺🇸 Detroit, Michigan, United States

Sutter Medical Center - Sacramento; 🇺🇸 Sacramento, California, United States

Jim Moran Heart & Vascular Research Institute; 🇺🇸 Fort Lauderdale, Florida, United States

Northeast Georgia Heart Center; 🇺🇸 Gainesville, Georgia, United States

Cardiovascular Institute of the South - Houma; 🇺🇸 Houma, Louisiana, United States

University of North Carolina - School of Medicine; 🇺🇸 Chapel Hill, North Carolina, United States

Heart Clinics Northwest; 🇺🇸 Spokane, Washington, United States

Nouvelles Cliniques Nantaises; 🇫🇷 Nantes cedex 2, France

Kerckhoff-Klinik GmbH; 🇩🇪 Bad Nauheim, Germany

Kardiologische Praxis; 🇩🇪 Bad Soden, Germany

Klinikum Quedlinburg GmbH Klinik fuer Innere Medizin und Kardiologie; 🇩🇪 Quedlinburg, Germany

Heart & Vascular Institute of Florida; 🇺🇸 Clearwater, Florida, United States

University of Florida at Jacksonville; 🇺🇸 Jacksonville, Florida, United States

Buffalo Heart Group; 🇺🇸 Buffalo, New York, United States