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 criteriaComposite of death, nonfatal myocardial infarct (MI), and urgent target vessel revascularization (TVR)
Secondary outcome: Angiographic complicationsFemoral 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
|