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

Phase 2

Completed

• Conditions: Coronary Artery Disease
• Interventions: Drug: REG1; Drug: Unfractionated Heparin

• Registration Number: NCT00715455
• Lead Sponsor: Regado Biosciences, Inc.

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 subjects with coronary artery disease (CAD).

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 undergo coronary revascularization procedures. These procedures, which include coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI), put patients at high risk for therapy-related bleeding complications. REG1 is being developed initially to increase therapeutic flexibility and improve patient outcomes in coronary revascularization procedures.

REG1 is a two-component system, consisting of an aptamer-based anticoagulant and its matched antidote. The REG1 anticoagulant component (RB006) is a single-stranded, nucleic acid aptamer. RB006 selectively and potently binds to and inhibits Factor IXa, a protein critical to blood coagulation. The antidote component, RB007, is a complementary nucleic acid that binds to and neutralizes RB006. The binding of RB007 to RB006 causes the predictable and rapid reversal of the RB006 effect and allows the patient's blood to return to normal.

Study Timeline

• Study Start: 2007-10
• Study First Submitted: 2008-02-14
• Study First Submitted QC: 2008-07-14
• Study First Posted: 2008-07-15
• Primary Completion: 2008-10
• Study Completion: 2008-10
• Status Verified: 2013-05
• Last Update Submitted: 2013-05-29
• Last Update Posted: 2013-05-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

• 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.

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Exclusion Criteria

• 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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
REG1 Partial Rev.	REG1	REG1 with partial reversal
REG1 Total Rev.	REG1	REG1 with total reversal
Unfractionated Heparin	Unfractionated Heparin	Unfractionated Heparin

Primary Outcome Measures

Name	Time	Method
Major bleeding using the ACUITY bleeding criteria	until hospital discharge or 48 hours whichever occurs first
Composite of death, nonfatal myocardial infarct (MI), and urgent target vessel revascularization (TVR)	through Day 14 (+/- 3 days)

Secondary Outcome Measures

Name	Time	Method
Angiographic complications	through Day 14 (+/- 3 days)
Femoral Sheath Complications	until the sheath is pulled

Trial Locations

Locations (6)

Black Hills Clinical Research Center; 🇺🇸 Rapid City, South Dakota, United States

Henry Ford; 🇺🇸 Detroit, Michigan, United States

The Care Group, LLC; 🇺🇸 Indianapolis, Indiana, United States

Geisinger; 🇺🇸 Danville, Pennsylvania, United States

UNC; 🇺🇸 Chapel Hill, North Carolina, United States

H. Italiano; 🇦🇷 Buenos Aires, Argentina