Clinical trial NCT00715455: Feasibility and Safety Study Comparing REG1 Anticoagulation System With Unfractionated Heparin in Elective 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Coronary Artery Disease
Keywords: CAD
PCI
ANTICOAGULANT
Lead sponsor: Regado Biosciences, Inc.
Sponsor class: INDUSTRY
First posted: 2008-07-15
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Major bleeding using the ACUITY bleeding criteria
timeFrame: until hospital discharge or 48 hours whichever occurs first
measure: Composite of death, nonfatal myocardial infarct (MI), and urgent target vessel revascularization (TVR)
timeFrame: through Day 14 (+/- 3 days)
Secondary outcomes:
measure: Angiographic complications
timeFrame: through Day 14 (+/- 3 days)
measure: Femoral Sheath Complications
timeFrame: until the sheath is pulled
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: The Care Group, LLC
state: Indiana
city: Detroit
country: United States
facility: Henry Ford
state: Michigan
city: Chapel Hill
country: United States
facility: UNC
state: North Carolina
city: Danville
country: United States
facility: Geisinger
state: Pennsylvania
city: Rapid City
country: United States
facility: Black Hills Clinical Research Center
state: South Dakota
city: Buenos Aires
country: Argentina
facility: H. Italiano
Study officials:
References:
citation: 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 as an anticoagulation strategy in patients undergoing percutaneous coronary intervention. Circulation. 2010 Aug 10;122(6):614-22. doi: 10.1161/CIRCULATIONAHA.109.927756. Epub 2010 Jul 26.
citation: Park EJ, Choi J, Lee KC, Na DH. Emerging PEGylated non-biologic drugs. Expert Opin Emerg Drugs. 2019 Jun;24(2):107-119. doi: 10.1080/14728214.2019.1604684. Epub 2019 Apr 19.