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

Primary Purpose

Coronary Artery Disease

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

REG1

Unfractionated Heparin

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring CAD, PCI, ANTICOAGULANT

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

The Care Group, LLC
Henry Ford
UNC
Geisinger
Black Hills Clinical Research Center
H. Italiano

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Arm Label

Unfractionated Heparin

REG1 Partial Rev.

REG1 Total Rev.

Arm Description

Unfractionated Heparin

REG1 with partial reversal

REG1 with total reversal

Outcomes

Primary Outcome Measures

Major bleeding using the ACUITY bleeding criteria

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

Secondary Outcome Measures

Angiographic complications

Femoral Sheath Complications

Full Information

NCT ID

NCT00715455

First Posted

February 14, 2008

Last Updated

May 29, 2013

Sponsor

Regado Biosciences, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT00715455

Brief Title

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

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2013

Overall Recruitment Status

Completed

Study Start Date

October 2007 (undefined)

Primary Completion Date

October 2008 (Actual)

Study Completion Date

October 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Regado Biosciences, Inc.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Coronary Artery Disease

Keywords

CAD, PCI, ANTICOAGULANT

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

26 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Unfractionated Heparin

Arm Type

Active Comparator

Arm Description

Unfractionated Heparin

Arm Title

REG1 Partial Rev.

Arm Type

Experimental

Arm Description

REG1 with partial reversal

Arm Title

REG1 Total Rev.

Arm Type

Experimental

Arm Description

REG1 with total reversal

Intervention Type

Drug

Intervention Name(s)

REG1

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

REG1

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Unfractionated Heparin

Other Intervention Name(s)

UFH

Intervention Description

Heparin will be administered per standard of care at sites

Primary Outcome Measure Information:

Title

Major bleeding using the ACUITY bleeding criteria

Time Frame

until hospital discharge or 48 hours whichever occurs first

Title

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

Time Frame

through Day 14 (+/- 3 days)

Secondary Outcome Measure Information:

Title

Angiographic complications

Time Frame

through Day 14 (+/- 3 days)

Title

Femoral Sheath Complications

Time Frame

until the sheath is pulled

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

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.

Facility Information:

Facility Name

The Care Group, LLC

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46290

Country

United States

Facility Name

Henry Ford

City

Detroit

State/Province

Michigan

ZIP/Postal Code

48202

Country

United States

Facility Name

UNC

City

Chapel Hill

State/Province

North Carolina

ZIP/Postal Code

27599

Country

United States

Facility Name

Geisinger

City

Danville

State/Province

Pennsylvania

ZIP/Postal Code

17822

Country

United States

Facility Name

Black Hills Clinical Research Center

City

Rapid City

State/Province

South Dakota

ZIP/Postal Code

57701

Country

United States

Facility Name

H. Italiano

City

Buenos Aires

Country

Argentina

12. IPD Sharing Statement

Citations:

PubMed Identifier

20660806

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.

Results Reference

result

PubMed Identifier

30957581

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.

Results Reference

derived

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

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