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

Information source: Regado Biosciences, Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Coronary Artery Disease

Intervention: REG1 (Drug); REG1 (Drug); Unfractionated Heparin (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Regado Biosciences, Inc.

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).

Clinical Details

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

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

Primary outcome:

Major bleeding using the ACUITY bleeding criteria

Composite of death, nonfatal myocardial infarct (MI), and urgent target vessel revascularization (TVR)

Secondary outcome:

Angiographic complications

Femoral Sheath Complications

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.

Eligibility

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.

Criteria:

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.

Locations and Contacts

H. Italiano, Buenos Aires, Argentina

The Care Group, LLC, Indianapolis, Indiana 46290, United States

Henry Ford, Detroit, Michigan 48202, United States

UNC, Chapel Hill, North Carolina 27599, United States

Geisinger, Danville, Pennsylvania 17822, United States

Black Hills Clinical Research Center, Rapid City, South Dakota 57701, United States

Additional Information

Starting date: October 2007
Last updated: May 29, 2013

Page last updated: August 23, 2015

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