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



Status:Completed
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - 80
Updated:10/14/2017
Start Date:July 2009
End Date:January 2011

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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.

Primary Outcome Bleeding Secondary Outcome Ischemia

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
We found this trial at
27
sites
Indianapolis, Indiana 46260
643
mi
from
Indianapolis, IN
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333 South Columbia Street
Chapel Hill, North Carolina 27599
1044
mi
from
Chapel Hill, NC
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455 Pinellas St., Suite 330
Clearwater, Florida 33756
1101
mi
from
Clearwater, FL
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2401 W Belvedere Ave
Baltimore, Maryland 21215
(410) 601-9000
Sinai Hospital of Baltimore Sinai Hospital of Baltimore provides a broad array of high-quality, cost-effective...
1145
mi
from
Baltimore, MD
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1039
mi
from
Boise, ID
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Buffalo, New York 14215
1060
mi
from
Buffalo, NY
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251 E Huron St
Chicago, Illinois 60611
(312) 926-2000
Northwestern Memorial Hospital Northwestern Memorial is an academic medical center hospital where the patient comes...
611
mi
from
Chicago, IL
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2600 Clifton Ave
Cincinnati, Ohio 45267
(513) 556-6000
University of Cincinnati The University of Cincinnati offers students a balance of educational excellence and...
726
mi
from
Cincinnati, OH
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Cypress, Texas 77429
550
mi
from
Cypress, TX
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Detroit, Michigan 48202
841
mi
from
Detroit, MI
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Fort Lauderdale, Florida 33308
1306
mi
from
Fort Lauderdale, FL
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Gainesville, Georgia
816
mi
from
Gainesville, GA
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?
mi
from
Gainsville, FL
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694
mi
from
Houma, LA
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Huntsville, Alabama 35801
660
mi
from
Huntsville, AL
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Jacksonville, Florida 32209
1053
mi
from
Jacksonville, FL
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3525 East Louise Drive
Meridian, Idaho 83642
1048
mi
from
Meridian, ID
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Milwaukee, Wisconsin 53215
633
mi
from
Milwaukee, WI
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1801 N Broad St
Philadelphia, Pennsylvania 19122
(215) 204-7000
Temple University Temple University is many things to many people. A place to pursue life's...
1226
mi
from
Philadelphia, PA
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Philadelphia, Pennsylvania 19104
1223
mi
from
Philadelphia, PA
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Rapid City, South Dakota 57701
520
mi
from
Rapid City, SD
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Sacramento, California 95819
1280
mi
from
Sacramento, CA
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Sacramento, California 95819
1280
mi
from
Sacramento, CA
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San Diego, California 92103
1142
mi
from
San Diego, CA
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550 17th Avenue
Seattle, Washington 98122
1409
mi
from
Seattle, WA
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Spokane, Washington 99204
1202
mi
from
Spokane, WA
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899 West 12th Avenue
Vancouver, British Columbia V5Z 1M9
1485
mi
from
Vancouver,
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