Feasibility and Safety Study Comparing REG1 Anticoagulation System With Unfractionated Heparin in Elective PCI

Completed · Phase 2

Conditions studied: Coronary Artery Disease

In brief

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 subjects with coronary artery disease (CAD).

Key facts

Study ID

NCT00715455

Run by

Regado Biosciences, Inc.

People needed

26

Starts

2007-10-01

Expected to finish

2008-10-01

Last updated by the study team

2013-05-31

Who can join

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

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• The Care Group, LLC — Indianapolis, Indiana, United States
• Henry Ford — Detroit, Michigan, United States
• UNC — Chapel Hill, North Carolina, United States
• Geisinger — Danville, Pennsylvania, United States
• Black Hills Clinical Research Center — Rapid City, South Dakota, United States
• H. Italiano — Buenos Aires, Argentina

Full record on ClinicalTrials.gov

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