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

Coronary Artery Disease Clinical Trial

— REVERSAL-PCI  

Official title:

Phase 2a, Multi-Center, Open Label, Randomized, Feasibility/Safety Study Comparing REG1 Anticoagulation System With Unfractionated Heparin in Subjects Undergoing Elective PCI After Pretreatment With Clopidogrel and Aspirin

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00715455
• Other study ID #: REG1-CLIN210
• Status: Completed
• Phase: Phase 2
• First received: February 14, 2008
• Last updated: May 29, 2013
• Start date: October 2007
• Est. completion date: October 2008

Study information

• Verified date: May 2013
• Source: Regado Biosciences, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationArgentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: October 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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.

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Drug:
• REG1
ii. The REG1 anticoagulation system consists of a drug (RB006) and antidote (RB007). The drug (RB006) is administered via IV bolus to achieve anticoagulation. The antidote (RB007) is administered as an IV bolus dose at approximately 10% the total reversal dose followed by the remaining dose several hours later to counteract RB006 induced anticoagulation.
• REG1
ii. The REG1 anticoagulation system consists of a drug (RB006) and antidote (RB007). The drug (RB006) is administered via IV bolus to achieve anticoagulation. The antidote (RB007) is administered as an IV bolus dose at 100% of the total reversal dose to counteract RB006 induced anticoagulation.
• Unfractionated Heparin
Heparin will be administered per standard of care at sites

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Regado Biosciences, Inc.

Countries where clinical trial is conducted

United States,  Argentina, 

References & Publications (1)

Cohen MG, Purdy DA, Rossi JS, Grinfeld LR, Myles SK, Aberle LH, Greenbaum AB, Fry E, Chan MY, Tonkens RM, Zelenkofske S, Alexander JH, Harrington RA, Rusconi CP, Becker RC. First clinical application of an actively reversible direct factor IXa inhibitor a — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major bleeding using the ACUITY bleeding criteria		until hospital discharge or 48 hours whichever occurs first	Yes
Primary	Composite of death, nonfatal myocardial infarct (MI), and urgent target vessel revascularization (TVR)		through Day 14 (+/- 3 days)	Yes
Secondary	Angiographic complications		through Day 14 (+/- 3 days)	Yes
Secondary	Femoral Sheath Complications		until the sheath is pulled	Yes