Feasibility and Safety Study Comparing REG1 Anticoagulation System With Unfractionated Heparin in Elective PCI (REVERSAL-PCI)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Regado Biosciences, Inc.
ClinicalTrials.gov Identifier:
NCT00715455
First received: February 14, 2008
Last updated: May 29, 2013
Last verified: May 2013
  Purpose

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).


Condition Intervention Phase
Coronary Artery Disease
Drug: REG1
Drug: Unfractionated Heparin
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Regado Biosciences, Inc.:

Primary Outcome Measures:
  • Major bleeding using the ACUITY bleeding criteria [ Time Frame: until hospital discharge or 48 hours whichever occurs first ] [ Designated as safety issue: Yes ]
  • Composite of death, nonfatal myocardial infarct (MI), and urgent target vessel revascularization (TVR) [ Time Frame: through Day 14 (+/- 3 days) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Angiographic complications [ Time Frame: through Day 14 (+/- 3 days) ] [ Designated as safety issue: Yes ]
  • Femoral Sheath Complications [ Time Frame: until the sheath is pulled ] [ Designated as safety issue: Yes ]

Enrollment: 26
Study Start Date: October 2007
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Unfractionated Heparin
Unfractionated Heparin
Drug: Unfractionated Heparin
Heparin will be administered per standard of care at sites
Other Name: UFH
Experimental: REG1 Partial Rev.
REG1 with partial reversal
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.
Experimental: REG1 Total Rev.
REG1 with total reversal
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 100% of the total reversal dose to counteract RB006 induced anticoagulation.

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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00715455

Locations
United States, Indiana
The Care Group, LLC
Indianapolis, Indiana, United States, 46290
United States, Michigan
Henry Ford
Detroit, Michigan, United States, 48202
United States, North Carolina
UNC
Chapel Hill, North Carolina, United States, 27599
United States, Pennsylvania
Geisinger
Danville, Pennsylvania, United States, 17822
United States, South Dakota
Black Hills Clinical Research Center
Rapid City, South Dakota, United States, 57701
Argentina
H. Italiano
Buenos Aires, Argentina
Sponsors and Collaborators
Regado Biosciences, Inc.
  More Information

Publications:
Cohen MG, Purdy DA, Rossi JS, Grinfeld LR, Aberle LH, Greenbaum AB, Fry ET, Alexander JA, Rusconi CP, Becker RC. First clinical application of an actively reversible direct factor IXa inhibitor in elective percutaneous coronary intervention. Eur Heart J 2009;30:101 (Abstract Supplement)

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Regado Biosciences, Inc.
ClinicalTrials.gov Identifier: NCT00715455     History of Changes
Other Study ID Numbers: REG1-CLIN210
Study First Received: February 14, 2008
Last Updated: May 29, 2013
Health Authority: United States: Food and Drug Administration
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica

Keywords provided by Regado Biosciences, Inc.:
CAD
PCI
ANTICOAGULANT

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Calcium heparin
Heparin
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on September 29, 2014