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

Completed · Phase 2

Conditions studied: Acute Coronary Syndrome (ACS)

In brief

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.

Key facts

Study ID

NCT00932100

Run by

Regado Biosciences, Inc.

People needed

640

Starts

2009-07-01

Expected to finish

2011-01-01

Last updated by the study team

2012-03-02

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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:
• 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;
• Elevated troponin I, T, or creatine phosphokinase-MB isoenzyme level within 24 hours of signing consent as defined by the universal MI definition
• Documented coronary artery disease as evidenced on prior angiography, or by prior angioplasty, bypass graft surgery, or myocardial infarction

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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