Status:
COMPLETED
A Study Assessing the REG1 Anticoagulation System Compared Heparin in Subjects With Acute Coronary Syndrome
Lead Sponsor:
Regado Biosciences, Inc.
Conditions:
Acute Coronary Syndrome (ACS)
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
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
- 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
Exclusion
- 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
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2011
Estimated Enrollment :
640 Patients enrolled
Trial Details
Trial ID
NCT00932100
Start Date
July 1 2009
End Date
January 1 2011
Last Update
March 2 2012
Active Locations (43)
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1
Heart Center Research LLC
Huntsville, Alabama, United States, 35801
2
Mercy Heart & Vascular Institute
Sacramento, California, United States, 95819
3
Sutter Medical Center - Sacramento
Sacramento, California, United States, 95819
4
Scripps Mercy Hospital
San Diego, California, United States, 92103