Status:
COMPLETED
Feasibility and Safety Study Comparing REG1 Anticoagulation System With Unfractionated Heparin in Elective PCI
Lead Sponsor:
Regado Biosciences, Inc.
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine if it is feasible and safe to use the REG1 Anticoagulation System instead of unfractionated heparin during percutaneous coronary intervention (PCI) in subject...
Detailed Description
The study drug, REG1, is the first specific, direct-acting, antidote-controlled anticoagulant ever described. Regado is developing REG1 for use in patients suffering from acute coronary syndrome who u...
Eligibility Criteria
Inclusion
- Males or females scheduled for non-urgent elective PCI (who do not have certain cardiac parameters) and have not been treated with UHF prior to PCI.
- Subject able to give informed consent and comply with the protocol.
- Negative urine pregnancy test or documented surgical sterilization or menopausal.
Exclusion
- Subject weight \>120 kg.
- Recent acute coronary syndrome with elevated cardiac markers or ST segment depression at rest.
- Evidence of clinical instability
- Angiographic high-risk.
- A contraindication to anticoagulation or increased risk of bleeding.
- Use of prohibited medications or investigational drugs prior to the study.
- Clinically significant abnormal laboratory findings.
- Planned use of femoral sheath greater than a certain size.
- Known allergy or intolerance to drugs mandated by the study.
- Use of devices other than angioplasty balloons and coronary stents.
- A history of licit drug abuse or illicit drug use or current evidence of such abuse.
- Any other factor that the Investigator feels would put the subject at increased risk if participating in the protocol.
- Lactation.
- Currently enrolled in this or another clinical trial (with some exceptions).
- Participation in an investigational drug or device trial in the past 30 days.
Key Trial Info
Start Date :
October 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2008
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT00715455
Start Date
October 1 2007
End Date
October 1 2008
Last Update
May 31 2013
Active Locations (6)
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1
The Care Group, LLC
Indianapolis, Indiana, United States, 46290
2
Henry Ford
Detroit, Michigan, United States, 48202
3
UNC
Chapel Hill, North Carolina, United States, 27599
4
Geisinger
Danville, Pennsylvania, United States, 17822